Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT05938920
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2023-06-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Insilico-Clinicaltrial@insilico.ai', 'phone': '+86-21-50831718', 'title': 'Yujin Tian', 'organization': 'InSilico Medicine Hong Kong Limited'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).', 'description': 'An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator).\n\nWithin a system organ class and preferred term, participants may report \\>1 AE. Participants are counted once per relationship, preferred term, and system organ class.', 'eventGroups': [{'id': 'EG000', 'title': 'INS018_055 30 mg QD', 'description': 'Group 1: INS018\\_055 once daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 13, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'INS018_055 30 mg BID', 'description': 'Group 2: INS018\\_055 twice daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'INS018_055 60 mg QD', 'description': 'Group 3: INS018\\_055 once daily up to 12 weeks, high dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Group 4: Placebo once or twice daily up to 12 weeks INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 12, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Carbohydrate antigen 19-9 increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Red blood cell sedimentation rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alpha hydroxybutyrate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bile acids increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood creatine phosphokinase MB increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood fibrinogen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Carbon dioxide decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Carotid intima-media thickness increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Electrocardiogram ST segment abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Electrocardiogram T wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Electrocardiogram high voltage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Glutamate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hepatic enzyme abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Immunoglobulins increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Interferon gamma level increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'QRS axis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Red blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Reticulocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Throxine free decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tri-iodothyronine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 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'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Prostatic calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'INS018_055 30 mg QD', 'description': 'Group 1: INS018\\_055 once daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG001', 'title': 'INS018_055 30 mg BID', 'description': 'Group 2: INS018\\_055 twice daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG002', 'title': 'INS018_055 60 mg QD', 'description': 'Group 3: INS018\\_055 once daily up to 12 weeks, high dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Group 4: Placebo once or twice daily up to 12 weeks\n\nPlacebo: Pharmaceutical formulation: Capsules\n\nMode of Administration: Oral'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'TEAE with CTCAE grade ≥3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'TEAE Leading to discontinuation of treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'TEAE Leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)', 'description': 'TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT.\n\nCTCAE=Common Terminology Criteria for Adverse Events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Relative Change From Baseline in Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'INS018_055 30 mg QD', 'description': 'Group 1: INS018\\_055 once daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG001', 'title': 'INS018_055 30 mg BID', 'description': 'Group 2: INS018\\_055 twice daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG002', 'title': 'INS018_055 60 mg QD', 'description': 'Group 3: INS018\\_055 once daily up to 12 weeks, high dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Group 4: Placebo once or twice daily up to 12 weeks\n\nPlacebo: Pharmaceutical formulation: Capsules\n\nMode of Administration: Oral'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7923', 'spread': '3.90508', 'groupId': 'OG000'}, {'value': '0.6821', 'spread': '6.09585', 'groupId': 'OG001'}, {'value': '3.2253', 'spread': '5.27457', 'groupId': 'OG002'}, {'value': '-0.7126', 'spread': '8.17452', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6098', 'ciLowerLimit': '-4.1026', 'ciUpperLimit': '2.8831', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.78193', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6721', 'ciLowerLimit': '-3.0738', 'ciUpperLimit': '4.4179', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.91075', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8232', 'ciLowerLimit': '-1.6970', 'ciUpperLimit': '7.3433', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.30479', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2933', 'ciLowerLimit': '-4.5273', 'ciUpperLimit': '3.9408', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.15954', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0/Visit 2 up to Week 12', 'description': 'Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.', 'unitOfMeasure': 'percentage change in FVC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Population: The ITT population included any randomized participant. The ITT Population was used for summary of demographic and baseline characteristics, and it was used for analysis of secondary endpoints except PK analysis'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in FVC in L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'INS018_055 30 mg QD', 'description': 'Group 1: INS018\\_055 once daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG001', 'title': 'INS018_055 30 mg BID', 'description': 'Group 2: INS018\\_055 twice daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG002', 'title': 'INS018_055 60 mg QD', 'description': 'Group 3: INS018\\_055 once daily up to 12 weeks, high dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Group 4: Placebo once or twice daily up to 12 weeks\n\nPlacebo: Pharmaceutical formulation: Capsules\n\nMode of Administration: Oral'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0270', 'spread': '0.11368', 'groupId': 'OG000'}, {'value': '0.0197', 'spread': '0.14177', 'groupId': 'OG001'}, {'value': '0.0984', 'spread': '0.14113', 'groupId': 'OG002'}, {'value': '-0.0203', 'spread': '0.18300', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0242', 'ciLowerLimit': '-0.1050', 'ciUpperLimit': '0.0566', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04121', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0194', 'ciLowerLimit': '-0.0687', 'ciUpperLimit': '0.1074', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04492', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0892', 'ciLowerLimit': '-0.0087', 'ciUpperLimit': '0.1872', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04994', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0082', 'ciLowerLimit': '-0.0981', 'ciUpperLimit': '0.0817', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04585', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0/Visit 2 up to Week 12', 'description': 'Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Population: The ITT population included any randomized participants. The ITT Population was used for summary of demographic and baseline characteristics, and it was used for analysis of secondary endpoints except PK analysis'}, {'type': 'SECONDARY', 'title': 'Absolute Change in FVC % Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'INS018_055 30 mg QD', 'description': 'Group 1: INS018\\_055 once daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG001', 'title': 'INS018_055 30 mg BID', 'description': 'Group 2: INS018\\_055 twice daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG002', 'title': 'INS018_055 60 mg QD', 'description': 'Group 3: INS018\\_055 once daily up to 12 weeks, high dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Group 4: Placebo once or twice daily up to 12 weeks\n\nPlacebo: Pharmaceutical formulation: Capsules\n\nMode of Administration: Oral'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6729', 'spread': '2.92554', 'groupId': 'OG000'}, {'value': '0.6455', 'spread': '3.73482', 'groupId': 'OG001'}, {'value': '3.0461', 'spread': '4.38853', 'groupId': 'OG002'}, {'value': '-0.5675', 'spread': '5.44712', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6043', 'ciLowerLimit': '-2.9549', 'ciUpperLimit': '1.7462', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.19916', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6510', 'ciLowerLimit': '-1.9603', 'ciUpperLimit': '3.2624', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.33193', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4975', 'ciLowerLimit': '-0.3187', 'ciUpperLimit': '5.3136', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.43617', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0209', 'ciLowerLimit': '-2.8142', 'ciUpperLimit': '2.7724', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.42470', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0/Visit 2 up to Week 12', 'description': 'Absolute change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment', 'unitOfMeasure': 'Percent predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Population: The ITT population included any randomized participant. The ITT Population was used for summary of demographic and baseline characteristics, and it was used for analysis of secondary endpoints except PK analysis.'}, {'type': 'SECONDARY', 'title': 'Relative Change in FVC % Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'INS018_055 30 mg QD', 'description': 'Group 1: INS018\\_055 once daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG001', 'title': 'INS018_055 30 mg BID', 'description': 'Group 2: INS018\\_055 twice daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'OG002', 'title': 'INS018_055 60 mg QD', 'description': 'Group 3: INS018\\_055 once daily up to 12 weeks, high dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration:Oral'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Group 4: Placebo once or twice daily up to 12 weeks\n\nPlacebo: Pharmaceutical formulation: Capsules\n\nMode of Administration: Oral'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6724', 'spread': '4.05537', 'groupId': 'OG000'}, {'value': '0.4434', 'spread': '5.96895', 'groupId': 'OG001'}, {'value': '3.2194', 'spread': '5.28129', 'groupId': 'OG002'}, {'value': '-0.8414', 'spread': '8.31651', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5762', 'ciLowerLimit': '-4.0035', 'ciUpperLimit': '2.8511', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.74854', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5884', 'ciLowerLimit': '-3.1449', 'ciUpperLimit': '4.3216', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.90433', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6554', 'ciLowerLimit': '-1.8486', 'ciUpperLimit': '7.1593', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.29650', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0625', 'ciLowerLimit': '-4.3227', 'ciUpperLimit': '4.1977', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.17274', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0/Visit 2 up to Week 12', 'description': 'Relative change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment', 'unitOfMeasure': 'Percent predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Population: The ITT population included any randomized participant. The ITT Population was used for summary of demographic and baseline characteristics, and it was used for analysis of secondary endpoints except PK analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'INS018_055 30 mg QD', 'description': 'Group 1: INS018\\_055 once daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'FG001', 'title': 'INS018_055 30 mg BID', 'description': 'Group 2: INS018\\_055 twice daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'FG002', 'title': 'INS018_055 60 mg QD', 'description': 'Group 3: INS018\\_055 once daily up to 12 weeks, high dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Group 4: Placebo once or twice daily up to 12 weeks INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participant Asked to Withdraw from the Trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participant Withdrew from Treatment and Refused to do Visit 7 Follow Up Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participant Refused to Come In', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'INS018_055 30 mg QD', 'description': 'Group 1: INS018\\_055 once daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'BG001', 'title': 'INS018_055 30 mg BID', 'description': 'Group 2: INS018\\_055 twice daily up to 12 weeks, low dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'BG002', 'title': 'INS018_055 60 mg QD', 'description': 'Group 3: INS018\\_055 once daily up to 12 weeks, high dose INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Group 4: Placebo once or twice daily up to 12 weeks INS018\\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'spread': '6.99', 'groupId': 'BG000'}, {'value': '67.2', 'spread': '7.77', 'groupId': 'BG001'}, {'value': '65.7', 'spread': '6.82', 'groupId': 'BG002'}, {'value': '68.3', 'spread': '5.28', 'groupId': 'BG003'}, {'value': '66.7', 'spread': '6.73', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≤ 65 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}, {'title': '> 65 to ≤ 75 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}, {'title': '>75 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '167.77', 'spread': '5.549', 'groupId': 'BG000'}, {'value': '165.78', 'spread': '7.869', 'groupId': 'BG001'}, {'value': '166.29', 'spread': '6.470', 'groupId': 'BG002'}, {'value': '164.50', 'spread': '7.874', 'groupId': 'BG003'}, {'value': '166.11', 'spread': '6.944', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '72.27', 'spread': '7.395', 'groupId': 'BG000'}, {'value': '67.36', 'spread': '12.141', 'groupId': 'BG001'}, {'value': '73.32', 'spread': '13.547', 'groupId': 'BG002'}, {'value': '67.69', 'spread': '12.117', 'groupId': 'BG003'}, {'value': '70.20', 'spread': '11.593', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '25.66', 'spread': '2.080', 'groupId': 'BG000'}, {'value': '24.41', 'spread': '3.399', 'groupId': 'BG001'}, {'value': '26.41', 'spread': '4.128', 'groupId': 'BG002'}, {'value': '24.96', 'spread': '3.733', 'groupId': 'BG003'}, {'value': '25.36', 'spread': '3.429', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Forced vital capacity (FVC) at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '2.6961', 'spread': '0.44422', 'groupId': 'BG000'}, {'value': '2.6170', 'spread': '0.66740', 'groupId': 'BG001'}, {'value': '2.7616', 'spread': '0.68415', 'groupId': 'BG002'}, {'value': '2.2456', 'spread': '0.47359', 'groupId': 'BG003'}, {'value': '2.5848', 'spread': '0.60040', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Decline (change) in FVC was assessed from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.', 'unitOfMeasure': 'liters (L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diffusion capacity of the lung for carbon monoxide (DLCO) (actual) at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '3.7832', 'spread': '1.03476', 'groupId': 'BG000'}, {'value': '3.4291', 'spread': '0.93188', 'groupId': 'BG001'}, {'value': '3.7561', 'spread': '1.25320', 'groupId': 'BG002'}, {'value': '3.6085', 'spread': '1.08683', 'groupId': 'BG003'}, {'value': '3.6447', 'spread': '1.06898', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'DLCO was assessed during the single breath diffusion test. Each study site used its own equipment and conducted all measurements using the same equipment. Baseline measurement (Visit 2) was the reference visit and change in DLCO (actual) from Week 0/Visit 2 to Week 12 was assessed. No more than 3 DLCO sessions were performed during the screening period.', 'unitOfMeasure': 'mmol/min/kPa', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diffusion capacity of the lung for carbon monoxide (DLCO) (% predicted) at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '47.6952', 'spread': '12.41070', 'groupId': 'BG000'}, {'value': '45.1767', 'spread': '10.55849', 'groupId': 'BG001'}, {'value': '48.9831', 'spread': '16.53697', 'groupId': 'BG002'}, {'value': '49.1347', 'spread': '15.72199', 'groupId': 'BG003'}, {'value': '47.7279', 'spread': '13.78235', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "DLCO (% predicted) is the percentage of the DLCO that is predicted based on the participant's hemoglobin level. DLCO was assessed during the single breath diffusion test. Each study site used its own equipment and conducted all measurements using the same equipment. Baseline measurement (Visit 2) was the reference visit and change in DLCO% predicted from Week 0/Visit 2 to Week 12 was assessed. No more than 3 DLCO sessions were performed during the screening period.", 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '6-minute walk distance (6-MWD) test (in meters) at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '420.81', 'spread': '122.020', 'groupId': 'BG000'}, {'value': '387.26', 'spread': '80.066', 'groupId': 'BG001'}, {'value': '378.04', 'spread': '76.252', 'groupId': 'BG002'}, {'value': '393.21', 'spread': '73.022', 'groupId': 'BG003'}, {'value': '394.85', 'spread': '89.806', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Participants had to rest for 30 minutes prior to performing the 6-minute walk test. The participant was instructed to walk on a flat, hard surface. The walk for 6 minutes was timed. After 6 minutes the distance the participant had walked was measured. Participants graded their level of dyspnea on a scale of 0 (no dyspnea) to 10 (maximal dyspnea) before walking. After walking, they were reminded of the level they selected pre-walk and then asked to grade again their level of dyspnea. Change in 6-MWD in meters, from Week 0 to Week 12 was assessed.', 'unitOfMeasure': 'meters (m)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Leicester Cough Questionnaire (LCQ) total score at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '17.1290', 'spread': '3.08860', 'groupId': 'BG000'}, {'value': '16.1677', 'spread': '3.51858', 'groupId': 'BG001'}, {'value': '15.7431', 'spread': '3.70099', 'groupId': 'BG002'}, {'value': '16.4370', 'spread': '3.05011', 'groupId': 'BG003'}, {'value': '16.3682', 'spread': '3.32222', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The LCQ is a 19-item self-administered questionnaire that assesses cough-related quality of life (QoL). Change in LCQ from Week 0 to Weeks 4, 8, and 12 was assessed. It examines 3 domains: physical, psychological, and social. The range for the total score on the LCQ is 3 to 21, and each domain score ranges from 1 to 7. The overall score for the LCQ for each participant was calculated by adding the individual domain scores. A higher score indicates a better QoL.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat (ITT) Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-02', 'size': 4126961, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-06T05:38', 'hasProtocol': True}, {'date': '2024-09-06', 'size': 2516210, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-29T09:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2023-06-28', 'resultsFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-14', 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)', 'description': 'TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT.\n\nCTCAE=Common Terminology Criteria for Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Relative Change From Baseline in Forced Vital Capacity (FVC)', 'timeFrame': 'Week 0/Visit 2 up to Week 12', 'description': 'Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.'}, {'measure': 'Absolute Change From Baseline in FVC in L', 'timeFrame': 'Week 0/Visit 2 up to Week 12', 'description': 'Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.'}, {'measure': 'Absolute Change in FVC % Predicted', 'timeFrame': 'Week 0/Visit 2 up to Week 12', 'description': 'Absolute change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment'}, {'measure': 'Relative Change in FVC % Predicted', 'timeFrame': 'Week 0/Visit 2 up to Week 12', 'description': 'Relative change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Fibrosis', 'Idiopathic Pulmonary Fibrosis', 'Fibrosis', 'Pathologic Processes', 'Lung Diseases, Interstitial', 'Lung Diseases', 'Respiratory Tract Diseases'], 'conditions': ['Idiopathic Pulmonary Fibrosis (IPF)']}, 'referencesModule': {'references': [{'pmid': '40461817', 'type': 'DERIVED', 'citation': 'Xu Z, Ren F, Wang P, Cao J, Tan C, Ma D, Zhao L, Dai J, Ding Y, Fang H, Li H, Liu H, Luo F, Meng Y, Pan P, Xiang P, Xiao Z, Rao S, Satler C, Liu S, Lv Y, Zhao H, Chen S, Cui H, Korzinkin M, Gennert D, Zhavoronkov A. A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial. Nat Med. 2025 Aug;31(8):2602-2610. doi: 10.1038/s41591-025-03743-2. Epub 2025 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about INS018\\_055 in adults with Idiopathic Pulmonary Fibrosis (IPF).\n\nThe primary objective is to evaluate the safety and tolerability of INS018\\_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients aged ≥40 years based on the date of the written informed consent form\n2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines\n3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation\n4. Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for \\> 8 weeks prior to Visit 1\n5. Meeting all of the following criteria during the screening period:\n\n 1. FVC ≥40% predicted of normal\n 2. DLCO corrected for Hgb ≥25% and \\<80% predicted of normal.\n 3. forced expiratory volume in the first second/FVC (FEV1/FVC) ratio \\>0.7 based on pre-bronchodilator value\n\nExclusion Criteria:\n\n1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or during the screening period, as determined by the investigator\n2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study\n3. Female patients who are pregnant or nursing\n4. Abnormal ECG findings\n\nOther protocol inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05938920', 'briefTitle': 'Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'InSilico Medicine Hong Kong Limited'}, 'officialTitle': 'A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)', 'orgStudyIdInfo': {'id': 'INS018-055-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INS018_055 30 mg QD', 'description': 'Group 1: INS018\\_055 once daily up to 12 weeks, low dose', 'interventionNames': ['Drug: INS018_055']}, {'type': 'EXPERIMENTAL', 'label': 'INS018_055 30 mg BID', 'description': 'Group 2: INS018\\_055 twice daily up to 12 weeks, low dose', 'interventionNames': ['Drug: INS018_055']}, {'type': 'EXPERIMENTAL', 'label': 'INS018_055 60 mg QD', 'description': 'Group 3: INS018\\_055 once daily up to 12 weeks, high dose', 'interventionNames': ['Drug: INS018_055']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group 4: Placebo once or twice daily up to 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'INS018_055', 'type': 'DRUG', 'description': 'Pharmaceutical formulation: Capsules\n\nMode of Administration: Oral', 'armGroupLabels': ['INS018_055 30 mg BID', 'INS018_055 30 mg QD', 'INS018_055 60 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical formulation: Capsules\n\nMode of Administration: Oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230031', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Chest Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '230601', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100041', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Shougang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '570311', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Hainan General Hospital', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': "Jiangxi Provincial People's Hospital", 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The Shengjing Hospital of China medical university', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250013', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201800', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '030032', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Bethune Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'The West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'General Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital - Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 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