Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-29 @ 5:36 PM
Study NCT ID:
NCT04067492
Status:
TERMINATED
Last Update Posted:
2022-07-25
First Post:
2019-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D015210', 'term': 'Arthritis, Gouty'}, {'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bukhanova@rpharm.ru', 'phone': '0074959567', 'title': 'D.V. Bukhanova, Medical Adviser', 'phoneExt': '3838', 'organization': 'R-Pharm'}, 'certainAgreement': {'otherDetails': 'Any study related information could be made public available only after Sponsors written permission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The safety of the investigational product was assessed over a 60-day period of therapy and follow-up. The tables show AEs that developed from the start of therapy.', 'description': 'The safety population included all subjects who received at least one dose of the investigational product. This population was used for all treatment safety assessments. The safety analysis of data was performed based on the actual treatment received by the patients.', 'eventGroups': [{'id': 'EG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 11, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastric disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastrointestinal scarring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Administration site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Genitourinary chlamydia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Mycoplasma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ureaplasma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lymphocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Mycobacterium tuberculosis complex test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neutrophil percentage decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Daydreaming', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Micturition disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Balanoposthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Mycobacterium tuberculosis complex test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Intensity in the Assessed Joint 72 Hours After the Initiation of Treatment in Comparison to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.88', 'groupId': 'OG000', 'lowerLimit': '-22.26', 'upperLimit': '6.50'}, {'value': '-38.56', 'groupId': 'OG001', 'lowerLimit': '-60.39', 'upperLimit': '-16.72'}, {'value': '-19.80', 'groupId': 'OG002', 'lowerLimit': '-41.83', 'upperLimit': '2.22'}, {'value': '-33.39', 'groupId': 'OG003', 'lowerLimit': '-55.53', 'upperLimit': '-11.24'}, {'value': '-30.55', 'groupId': 'OG004', 'lowerLimit': '-54.46', 'upperLimit': '-6.64'}, {'value': '-36.51', 'groupId': 'OG005', 'lowerLimit': '-55.11', 'upperLimit': '-17.90'}]}]}], 'analyses': [{'pValue': '0.1331', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.63', 'ciLowerLimit': '4.21', 'ciUpperLimit': '53.05', 'pValueComment': 'p-value, group', 'estimateComment': 'Adjusted mean difference. Comparison with the control group \\[RPH-104 - Diclofenac\\].', 'groupDescription': 'It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.\n\nThe sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours.'}, {'pValue': '0.1331', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.05', 'ciLowerLimit': '-30.60', 'ciUpperLimit': '26.50', 'pValueComment': 'p-value, group', 'estimateComment': 'Adjusted mean difference. Comparison with the control group \\[RPH-104 - Diclofenac\\].', 'groupDescription': 'It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.\n\nThe sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours.'}, {'pValue': '0.1331', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.70', 'ciLowerLimit': '-12.67', 'ciUpperLimit': '46.08', 'pValueComment': 'p-value, group', 'estimateComment': 'Adjusted mean difference. Comparison with the control group \\[RPH-104 - Diclofenac\\].', 'groupDescription': 'It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.\n\nThe sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours.'}, {'pValue': '0.1331', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.12', 'ciLowerLimit': '-25.10', 'ciUpperLimit': '31.33', 'pValueComment': 'p-value, group', 'estimateComment': 'Adjusted mean difference. Comparison with the control group \\[RPH-104 - Diclofenac\\]', 'groupDescription': 'It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.\n\nThe sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours.'}, {'pValue': '0.1331', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.96', 'ciLowerLimit': '-24.22', 'ciUpperLimit': '36.14', 'pValueComment': 'p-value, group', 'estimateComment': 'Adjusted mean difference. Comparison with the control group \\[RPH-104 - Diclofenac\\].', 'groupDescription': 'It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.\n\nThe sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 4 (72 hours after the initiation of treatment with the test drug)', 'description': 'Change in pain intensity in the assessed joint 72 hours after the initiation of treatment with the test drug measured using the Visual Analogue Scale (VAS) in comparison to baseline. VAS is a hard copy 100 mm scale with the indications: "Absence of pain" on the left side of the scale (0 mm point) and "The most severe pain ever experienced" on the right side of the scale (100 mm point)) The better outcome would be "Absence of pain", the worse outcome would be "The most severe pain ever experienced".', 'unitOfMeasure': 'mm (VAS scale)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline observation carried forward method (BOCF) was used to impute missing data for the main efficacy analysis. Missing patient data were replaced with baseline values from the time of patient discontinuation or use of the rescue medication.'}, {'type': 'SECONDARY', 'title': 'Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Day 1/15 minutes', 'categories': [{'measurements': [{'value': '-2.00', 'groupId': 'OG000', 'lowerLimit': '-6.38', 'upperLimit': '2.38'}, {'value': '-6.97', 'groupId': 'OG001', 'lowerLimit': '-13.81', 'upperLimit': '-0.14'}, {'value': '-5.91', 'groupId': 'OG002', 'lowerLimit': '-12.76', 'upperLimit': '0.94'}, {'value': '-1.52', 'groupId': 'OG003', 'lowerLimit': '-8.39', 'upperLimit': '5.34'}, {'value': '-5.75', 'groupId': 'OG004', 'lowerLimit': '-13.23', 'upperLimit': '1.74'}, {'value': '-3.78', 'groupId': 'OG005', 'lowerLimit': '-9.44', 'upperLimit': '1.88'}]}]}, {'title': 'Day 1/30 minutes', 'categories': [{'measurements': [{'value': '-10.00', 'groupId': 'OG000', 'lowerLimit': '-16.81', 'upperLimit': '-3.19'}, {'value': '-14.16', 'groupId': 'OG001', 'lowerLimit': '-24.87', 'upperLimit': '-3.45'}, {'value': '-6.43', 'groupId': 'OG002', 'lowerLimit': '-17.15', 'upperLimit': '4.29'}, {'value': '-5.19', 'groupId': 'OG003', 'lowerLimit': '-15.92', 'upperLimit': '5.54'}, {'value': '-10.57', 'groupId': 'OG004', 'lowerLimit': '-22.30', 'upperLimit': '1.16'}, {'value': '-5.45', 'groupId': 'OG005', 'lowerLimit': '-14.24', 'upperLimit': '3.35'}]}]}, {'title': 'Day 1/45 minutes', 'categories': [{'measurements': [{'value': '-16.20', 'groupId': 'OG000', 'lowerLimit': '-24.71', 'upperLimit': '-7.69'}, {'value': '-16.14', 'groupId': 'OG001', 'lowerLimit': '-29.55', 'upperLimit': '-2.73'}, {'value': '-7.91', 'groupId': 'OG002', 'lowerLimit': '-21.33', 'upperLimit': '5.51'}, {'value': '-9.36', 'groupId': 'OG003', 'lowerLimit': '-22.78', 'upperLimit': '4.07'}, {'value': '-11.77', 'groupId': 'OG004', 'lowerLimit': '-26.45', 'upperLimit': '2.92'}, {'value': '-8.56', 'groupId': 'OG005', 'lowerLimit': '-19.55', 'upperLimit': '2.43'}]}]}, {'title': 'Day 1/ 1 hour', 'categories': [{'measurements': [{'value': '-19.67', 'groupId': 'OG000', 'lowerLimit': '-30.12', 'upperLimit': '-9.21'}, {'value': '-15.81', 'groupId': 'OG001', 'lowerLimit': '-32.30', 'upperLimit': '0.69'}, {'value': '-11.76', 'groupId': 'OG002', 'lowerLimit': '-28.27', 'upperLimit': '4.74'}, {'value': '-12.52', 'groupId': 'OG003', 'lowerLimit': '-29.03', 'upperLimit': '3.99'}, {'value': '-15.99', 'groupId': 'OG004', 'lowerLimit': '-34.06', 'upperLimit': '2.09'}, {'value': '-12.67', 'groupId': 'OG005', 'lowerLimit': '-26.17', 'upperLimit': '0.83'}]}]}, {'title': 'Day 1/ 1.5 hours', 'categories': [{'measurements': [{'value': '-22.47', 'groupId': 'OG000', 'lowerLimit': '-32.96', 'upperLimit': '-11.97'}, {'value': '-15.14', 'groupId': 'OG001', 'lowerLimit': '-31.70', 'upperLimit': '1.42'}, {'value': '-21.26', 'groupId': 'OG002', 'lowerLimit': '-37.82', 'upperLimit': '-4.70'}, {'value': '-14.69', 'groupId': 'OG003', 'lowerLimit': '-31.26', 'upperLimit': '1.88'}, {'value': '-17.79', 'groupId': 'OG004', 'lowerLimit': '-35.92', 'upperLimit': '0.35'}, {'value': '-13.67', 'groupId': 'OG005', 'lowerLimit': '-27.22', 'upperLimit': '-0.12'}]}]}, {'title': 'Day 1/ 2 hours', 'categories': [{'measurements': [{'value': '-22.07', 'groupId': 'OG000', 'lowerLimit': '-33.65', 'upperLimit': '-10.48'}, {'value': '-25.14', 'groupId': 'OG001', 'lowerLimit': '-43.42', 'upperLimit': '-6.86'}, {'value': '-24.63', 'groupId': 'OG002', 'lowerLimit': '-42.92', 'upperLimit': '-6.34'}, {'value': '-13.86', 'groupId': 'OG003', 'lowerLimit': '-32.15', 'upperLimit': '4.44'}, {'value': '-19.59', 'groupId': 'OG004', 'lowerLimit': '-39.62', 'upperLimit': '0.44'}, {'value': '-20.56', 'groupId': 'OG005', 'lowerLimit': '-35.52', 'upperLimit': '-5.60'}]}]}, {'title': 'Day 1/ 4 hours', 'categories': [{'measurements': [{'value': '-21.87', 'groupId': 'OG000', 'lowerLimit': '-34.63', 'upperLimit': '-9.10'}, {'value': '-27.27', 'groupId': 'OG001', 'lowerLimit': '-47.43', 'upperLimit': '-7.12'}, {'value': '-21.44', 'groupId': 'OG002', 'lowerLimit': '-41.61', 'upperLimit': '-1.28'}, {'value': '-14.36', 'groupId': 'OG003', 'lowerLimit': '-34.52', 'upperLimit': '5.81'}, {'value': '-20.35', 'groupId': 'OG004', 'lowerLimit': '-42.43', 'upperLimit': '1.73'}, {'value': '-22.67', 'groupId': 'OG005', 'lowerLimit': '-39.15', 'upperLimit': '-6.19'}]}]}, {'title': 'Day 1/ 8 hours', 'categories': [{'measurements': [{'value': '-14.20', 'groupId': 'OG000', 'lowerLimit': '-27.05', 'upperLimit': '-1.35'}, {'value': '-29.61', 'groupId': 'OG001', 'lowerLimit': '-49.89', 'upperLimit': '-9.32'}, {'value': '-18.93', 'groupId': 'OG002', 'lowerLimit': '-39.22', 'upperLimit': '1.36'}, {'value': '-16.52', 'groupId': 'OG003', 'lowerLimit': '-36.82', 'upperLimit': '3.77'}, {'value': '-25.35', 'groupId': 'OG004', 'lowerLimit': '-47.57', 'upperLimit': '-3.13'}, {'value': '-25.67', 'groupId': 'OG005', 'lowerLimit': '-42.26', 'upperLimit': '-9.08'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '-10.60', 'groupId': 'OG000', 'lowerLimit': '-23.27', 'upperLimit': '2.07'}, {'value': '-37.77', 'groupId': 'OG001', 'lowerLimit': '-57.77', 'upperLimit': '-17.78'}, {'value': '-20.94', 'groupId': 'OG002', 'lowerLimit': '-40.95', 'upperLimit': '-0.94'}, {'value': '-25.52', 'groupId': 'OG003', 'lowerLimit': '-45.53', 'upperLimit': '-5.52'}, {'value': '-30.35', 'groupId': 'OG004', 'lowerLimit': '-52.25', 'upperLimit': '-8.44'}, {'value': '-30.34', 'groupId': 'OG005', 'lowerLimit': '-46.69', 'upperLimit': '-13.98'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '-3.33', 'groupId': 'OG000', 'lowerLimit': '-16.21', 'upperLimit': '9.54'}, {'value': '-35.77', 'groupId': 'OG001', 'lowerLimit': '-56.10', 'upperLimit': '-15.45'}, {'value': '-27.94', 'groupId': 'OG002', 'lowerLimit': '-48.28', 'upperLimit': '-7.61'}, {'value': '-34.69', 'groupId': 'OG003', 'lowerLimit': '-55.03', 'upperLimit': '-14.35'}, {'value': '-30.15', 'groupId': 'OG004', 'lowerLimit': '-52.41', 'upperLimit': '-7.88'}, {'value': '-38.67', 'groupId': 'OG005', 'lowerLimit': '-55.29', 'upperLimit': '-22.05'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '-6.67', 'groupId': 'OG000', 'lowerLimit': '-20.38', 'upperLimit': '7.05'}, {'value': '-38.77', 'groupId': 'OG001', 'lowerLimit': '-60.43', 'upperLimit': '-17.11'}, {'value': '-18.91', 'groupId': 'OG002', 'lowerLimit': '-40.58', 'upperLimit': '2.76'}, {'value': '-34.52', 'groupId': 'OG003', 'lowerLimit': '-56.19', 'upperLimit': '-12.85'}, {'value': '-30.75', 'groupId': 'OG004', 'lowerLimit': '-54.47', 'upperLimit': '-7.02'}, {'value': '-38.12', 'groupId': 'OG005', 'lowerLimit': '-55.83', 'upperLimit': '-20.40'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '-4.73', 'groupId': 'OG000', 'lowerLimit': '-18.62', 'upperLimit': '9.15'}, {'value': '-31.27', 'groupId': 'OG001', 'lowerLimit': '-53.20', 'upperLimit': '-9.35'}, {'value': '-13.64', 'groupId': 'OG002', 'lowerLimit': '-35.57', 'upperLimit': '8.28'}, {'value': '-35.86', 'groupId': 'OG003', 'lowerLimit': '-57.79', 'upperLimit': '-13.92'}, {'value': '-31.35', 'groupId': 'OG004', 'lowerLimit': '-55.36', 'upperLimit': '-7.33'}, {'value': '-42.78', 'groupId': 'OG005', 'lowerLimit': '-60.71', 'upperLimit': '-24.86'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '-4.80', 'groupId': 'OG000', 'lowerLimit': '-18.42', 'upperLimit': '8.82'}, {'value': '-34.44', 'groupId': 'OG001', 'lowerLimit': '-55.95', 'upperLimit': '-12.93'}, {'value': '-12.43', 'groupId': 'OG002', 'lowerLimit': '-33.95', 'upperLimit': '9.09'}, {'value': '-22.86', 'groupId': 'OG003', 'lowerLimit': '-44.38', 'upperLimit': '-1.33'}, {'value': '-29.15', 'groupId': 'OG004', 'lowerLimit': '-52.71', 'upperLimit': '-5.58'}, {'value': '-42.45', 'groupId': 'OG005', 'lowerLimit': '-60.04', 'upperLimit': '-24.86'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '-6.73', 'groupId': 'OG000', 'lowerLimit': '-21.29', 'upperLimit': '7.82'}, {'value': '-37.27', 'groupId': 'OG001', 'lowerLimit': '-60.26', 'upperLimit': '-14.29'}, {'value': '-12.43', 'groupId': 'OG002', 'lowerLimit': '-35.42', 'upperLimit': '10.57'}, {'value': '-23.52', 'groupId': 'OG003', 'lowerLimit': '-46.52', 'upperLimit': '-0.53'}, {'value': '-29.15', 'groupId': 'OG004', 'lowerLimit': '-54.33', 'upperLimit': '-3.96'}, {'value': '-37.78', 'groupId': 'OG005', 'lowerLimit': '-56.57', 'upperLimit': '-18.99'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-4.13', 'groupId': 'OG000', 'lowerLimit': '-18.21', 'upperLimit': '9.94'}, {'value': '-41.77', 'groupId': 'OG001', 'lowerLimit': '-64.00', 'upperLimit': '-19.55'}, {'value': '-12.41', 'groupId': 'OG002', 'lowerLimit': '-34.64', 'upperLimit': '9.82'}, {'value': '-12.69', 'groupId': 'OG003', 'lowerLimit': '-34.93', 'upperLimit': '9.55'}, {'value': '-28.95', 'groupId': 'OG004', 'lowerLimit': '-53.30', 'upperLimit': '-4.60'}, {'value': '-38.34', 'groupId': 'OG005', 'lowerLimit': '-56.51', 'upperLimit': '-20.16'}]}]}, {'title': 'Day 18', 'categories': [{'measurements': [{'value': '-4.07', 'groupId': 'OG000', 'lowerLimit': '-18.18', 'upperLimit': '10.05'}, {'value': '-42.61', 'groupId': 'OG001', 'lowerLimit': '-64.90', 'upperLimit': '-20.31'}, {'value': '-12.74', 'groupId': 'OG002', 'lowerLimit': '-35.04', 'upperLimit': '9.55'}, {'value': '-12.69', 'groupId': 'OG003', 'lowerLimit': '-34.99', 'upperLimit': '9.61'}, {'value': '-29.75', 'groupId': 'OG004', 'lowerLimit': '-54.17', 'upperLimit': '-5.33'}, {'value': '-28.45', 'groupId': 'OG005', 'lowerLimit': '-46.67', 'upperLimit': '-10.22'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '-3.20', 'groupId': 'OG000', 'lowerLimit': '-17.43', 'upperLimit': '11.03'}, {'value': '-44.61', 'groupId': 'OG001', 'lowerLimit': '-67.08', 'upperLimit': '-22.14'}, {'value': '-13.58', 'groupId': 'OG002', 'lowerLimit': '-36.05', 'upperLimit': '8.90'}, {'value': '-12.69', 'groupId': 'OG003', 'lowerLimit': '-35.17', 'upperLimit': '9.79'}, {'value': '-28.35', 'groupId': 'OG004', 'lowerLimit': '-52.96', 'upperLimit': '-3.73'}, {'value': '-30.34', 'groupId': 'OG005', 'lowerLimit': '-48.71', 'upperLimit': '-11.97'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '-4.07', 'groupId': 'OG000', 'lowerLimit': '-18.36', 'upperLimit': '10.23'}, {'value': '-44.94', 'groupId': 'OG001', 'lowerLimit': '-67.52', 'upperLimit': '-22.36'}, {'value': '-13.58', 'groupId': 'OG002', 'lowerLimit': '-36.16', 'upperLimit': '9.01'}, {'value': '-12.69', 'groupId': 'OG003', 'lowerLimit': '-35.28', 'upperLimit': '9.90'}, {'value': '-17.95', 'groupId': 'OG004', 'lowerLimit': '-42.68', 'upperLimit': '6.79'}, {'value': '-23.89', 'groupId': 'OG005', 'lowerLimit': '-42.35', 'upperLimit': '-5.43'}]}]}, {'title': 'Day 45', 'categories': [{'measurements': [{'value': '-2.60', 'groupId': 'OG000', 'lowerLimit': '-16.67', 'upperLimit': '11.48'}, {'value': '-46.94', 'groupId': 'OG001', 'lowerLimit': '-69.17', 'upperLimit': '-24.71'}, {'value': '-13.58', 'groupId': 'OG002', 'lowerLimit': '-35.81', 'upperLimit': '8.66'}, {'value': '-12.69', 'groupId': 'OG003', 'lowerLimit': '-34.93', 'upperLimit': '9.55'}, {'value': '-19.75', 'groupId': 'OG004', 'lowerLimit': '-44.09', 'upperLimit': '4.60'}, {'value': '-23.34', 'groupId': 'OG005', 'lowerLimit': '-41.51', 'upperLimit': '-5.16'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment', 'description': 'Change in pain intensity in the assessed joint in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug measured using the Visual Analogue Scale (VAS) and compared to baseline. VAS is a hard copy 100 mm scale with the indications: "Absence of pain" on the left side of the scale (0 mm point) and "The most severe pain ever experienced" on the right side of the scale (100 mm point)) The better outcome would be "Absence of pain", the worse outcome would be "The most severe pain ever experienced".', 'unitOfMeasure': 'mm (VAS scale)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline observation carried forward method (BOCF) was used to impute missing data for the main efficacy analysis. Missing patient data were replaced with baseline values from the time of patient discontinuation or use of the rescue medication.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as "Excellent" or "Good"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Day 1/15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Day 1/30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 1/45 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 1/ 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Day 1/ 1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Day 1/ 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Day 1/ 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 1/ 8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment with the test drug', 'description': 'Proportion of patients who assessed the response to therapy with the test drug as "Excellent" or "Good" in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug.\n\nThe patient\'s response to therapy was assessed in the form of frequency tables by assessment point and therapy group. The rates of the response were specified in the evaluation form as: "Excellent", "Good", "Fair", "Weak", "Poor" (where "excellent" represents the best possible response to treatment and "poor" indicates the worst treatment response).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The table shows the frequencies and proportions (%) of the number of valid observations. Values after the use of rescue medication and after withdrawal were imputed as failure.'}, {'type': 'SECONDARY', 'title': 'Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 3/ 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the rate of swelling of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. The rates of swelling were specified in the evaluation form as: "absence" = no swelling, "mild" = palpable swelling, "moderate" = visible swelling, "severe" = bulging outside the joint (where "severe" represented the worst possible degree of swelling and "absence" was the best outcome).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics, therefore, the number of patients with analyzable data in treatment groups decreased over time.'}, {'type': 'SECONDARY', 'title': 'Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 3/ 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the rate of tenderness of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. Tenderness degrees: "absent" = no tenderness, "mild" = tenderness when touched, "moderate" = pain and flinching, "severe" = pain, flinching and withdrawal of the limb (where "severe" represents the worst possible degree of tenderness and "absent" is the best outcome).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics, therefore, the number of patients with analyzable data in treatment groups decreased over time.'}, {'type': 'SECONDARY', 'title': 'Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 3/ 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': 'absence', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'presence', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'evaluation impossible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the rate of erythema of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline.The rates of "erythema" were specified as "absence", "presence", "impossible to evaluate".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics, therefore, the number of patients with analyzable data in treatment groups decreased over time.'}, {'type': 'SECONDARY', 'title': 'Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 3/ 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the rate of movement restrictions in the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. For the assessment, the categorical scale consistent with the Form for evaluation (Investigator\'s Assessment) of the restriction of movements was used. The rates of movement restrictions (amplitude of movements) were specified in the evaluation form as "1 - Normal range", "2 - Slightly limited range", " 3 - Moderately limited range" ,"4 - Severely limited range" and "5 - Joint movement is impossible " (where higher score means worse outcome).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics, therefore, the number of patients with analyzable data in treatment groups decreased over time.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve the 50% Decrease in Pain Intensity in the Assessed Joint Relative to the Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'No median estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': 'NA'}, {'value': '6.0', 'comment': 'No CI estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No median estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No median estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': 'NA'}, {'value': '8.0', 'comment': 'No CI estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': 'NA'}, {'value': '47.3', 'comment': 'No CI estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG005', 'lowerLimit': '0.8', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.5995', 'groupIds': ['OG001', 'OG005'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9012', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and one of the pain intensity measurements in accordance with the schedule: 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment', 'description': 'Time to achieve the 50% decrease in pain intensity in the assessed joint relative to the baseline VAS level.\n\nVAS is a hard copy 100 mm scale with the indications: "Absence of pain" on the left side of the scale (0 mm point) and "The most severe pain ever experienced" on the right side of the scale (100 mm point)). The better outcome would be "Absence of pain", the worse outcome would be "The most severe pain ever experienced".', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Use of the Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '24.5'}, {'value': 'NA', 'comment': 'No median estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': 'NA'}, {'value': '71.8', 'comment': 'No CI estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG002', 'lowerLimit': '24.4', 'upperLimit': 'NA'}, {'value': '84.6', 'comment': 'No CI estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG003', 'lowerLimit': '22.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No median estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No median estimate was obtained due to the small group sizes and the small number of events assessed.', 'groupId': 'OG005', 'lowerLimit': '4.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from the date/time of IP administration (first dose) to the date/time of the first use of the rescue medication, up to day 60', 'description': 'Time to use of the rescue medication was calculated as the time in hours from the date/time of administration (first dose) of the investigational product to the date/time of the first use of the rescue medication.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient 01003 was excluded from the analysis of the endpoint due to the use of prohibited therapy (methylprednisolone 125 mg, IV, daily from the 2nd day of therapy until the end of the study).'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Received a Rescue Therapy Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0066', 'groupIds': ['OG000', 'OG005'], 'paramType': 'difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '63.5', 'ciLowerLimit': '19.9', 'ciUpperLimit': '88.6', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '>0.9999', 'groupIds': ['OG001', 'OG005'], 'paramType': 'difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.6', 'ciLowerLimit': '-50.1', 'ciUpperLimit': '45.5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3287', 'groupIds': ['OG002', 'OG005'], 'paramType': 'difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.8', 'ciLowerLimit': '-26.8', 'ciUpperLimit': '71.8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3287', 'groupIds': ['OG003', 'OG005'], 'paramType': 'difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.8', 'ciLowerLimit': '-26.8', 'ciUpperLimit': '71.8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5804', 'groupIds': ['OG004', 'OG005'], 'paramType': 'difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.8', 'ciLowerLimit': '-33.7', 'ciUpperLimit': '67.8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours after the initiation of treatment with the test drug', 'description': 'The proportion of patients who received the rescue medication within 72 hours of starting the investigational product therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient 01003 was excluded from the analysis of the endpoint due to the use of prohibited therapy (methylprednisolone 125 mg, IV, daily from the 2nd day of therapy until the end of the study).'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Received a Rescue Therapy Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to day 60', 'description': 'The proportion of patients who received the rescue medication over the entire treatment period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient 01003 was excluded from the analysis of the endpoint due to the use of prohibited therapy (methylprednisolone 125 mg, IV, daily from the 2nd day of therapy until the end of the study).'}, {'type': 'SECONDARY', 'title': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.802', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.578', 'groupId': 'OG001'}, {'value': '1.75', 'spread': '0.806', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '0.649', 'groupId': 'OG003'}, {'value': '1.6', 'spread': '0.615', 'groupId': 'OG004'}, {'value': '1.32', 'spread': '0.577', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.685', 'groupId': 'OG001'}, {'value': '-0.88', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-0.63', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-1.06', 'spread': '0.619', 'groupId': 'OG004'}, {'value': '-0.56', 'spread': '0.342', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.672', 'groupId': 'OG001'}, {'value': '-1.25', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-0.63', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.53', 'groupId': 'OG004'}, {'value': '-0.38', 'spread': '0.144', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '0.382', 'groupId': 'OG001'}, {'value': '-1.38', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-0.63', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.56', 'spread': '0.619', 'groupId': 'OG004'}, {'value': '-0.44', 'spread': '0.298', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\n(The result for each of the 8 categories ("Dressing and Grooming", "Arising", "Eating", "Walking", "Hygiene", "Reach", "Grip", "Activities") of the HAQ questionnaire was calculated as the maximum score of responses (on an ordinal scale from 0 (best) to 3 (worst): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3)) to questions included in this category. If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2". The sum of points for the evaluated categories was calculated and divided by the number of categories, which gives a disability index in the range of 0 to 3.)', 'unitOfMeasure': 'units of the HAQ index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetics (PK) - Area Under the Plasma concentration-of RPH-104 Under the Subcutaneous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}], 'classes': [{'categories': [{'measurements': [{'value': '38000', 'spread': '124', 'groupId': 'OG000'}, {'value': '762000', 'spread': '152', 'groupId': 'OG001'}, {'value': '845000', 'spread': '45', 'groupId': 'OG002'}, {'value': '1620000', 'spread': '36.5', 'groupId': 'OG003'}, {'value': '3230000', 'spread': '38.2', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including area under the plasma concentration-time curve over the dosing interval (AUC0-tau)', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetics (PK) - Area Under the Active Substance Concentration- of RPH-104 Under the Subcutaneous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}], 'classes': [{'categories': [{'measurements': [{'value': '47900', 'spread': '97.9', 'groupId': 'OG000'}, {'value': '816000', 'spread': '155', 'groupId': 'OG001'}, {'value': '901000', 'spread': '44.3', 'groupId': 'OG002'}, {'value': '1720000', 'spread': '37.1', 'groupId': 'OG003'}, {'value': '3380000', 'spread': '38.1', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including Area under the active substance concentration-time curve from zero (before drug administration) to infinity (AUC0-∞)', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetics (PK) - Maximum Concentration of the Active Substance -of RPH-104 Under the Subcutaneous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'spread': '110', 'groupId': 'OG000'}, {'value': '2220', 'spread': '155', 'groupId': 'OG001'}, {'value': '2380', 'spread': '47.7', 'groupId': 'OG002'}, {'value': '4860', 'spread': '18', 'groupId': 'OG003'}, {'value': '9760', 'spread': '38.2', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including Maximum concentration of the active substance (Cmax)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetics (PK) of RPH-104 Under the Subcutaneous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00298', 'spread': '0.000573', 'groupId': 'OG000'}, {'value': '0.00314', 'spread': '0.000622', 'groupId': 'OG001'}, {'value': '0.00304', 'spread': '0.000241', 'groupId': 'OG002'}, {'value': '0.00317', 'spread': '0.000575', 'groupId': 'OG003'}, {'value': '0.00294', 'spread': '0.000311', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including elimination constant (Kel)', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetics (PK) -Time to Reach Maximum Concentration of the Active Substance - of RPH-104 Under the Subcutaneous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 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'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '120'}, {'value': '47.5', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '72.1'}, {'value': '84.8', 'groupId': 'OG002', 'lowerLimit': '47.1', 'upperLimit': '120'}, {'value': '82.7', 'groupId': 'OG003', 'lowerLimit': '24', 'upperLimit': '122'}, {'value': '94.4', 'groupId': 'OG004', 'lowerLimit': '72', 'upperLimit': '96.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including Time to reach maximum concentration of the active substance (tmax)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetics (PK) - Terminal Half-life -of RPH-104 Under the Subcutaneous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection 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Timeframes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '36.673', 'spread': '31.3545', 'groupId': 'OG000'}, {'value': '8.295', 'spread': '6.6212', 'groupId': 'OG001'}, {'value': '10.105', 'spread': '14.2834', 'groupId': 'OG002'}, {'value': '37.908', 'spread': 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'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '33.894', 'spread': '35.0873', 'groupId': 'OG000'}, {'value': '3.408', 'spread': '0.8120', 'groupId': 'OG001'}, {'value': '12.900', 'spread': '9.3579', 'groupId': 'OG002'}, {'value': '11.846', 'spread': '6.1780', 'groupId': 'OG003'}, {'value': '8.678', 'spread': '10.5037', 'groupId': 'OG004'}, {'value': '9.279', 'spread': '8.1642', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '32.279', 'spread': '32.6858', 'groupId': 'OG000'}, {'value': '3.090', 'spread': '0.9076', 'groupId': 'OG001'}, {'value': '7.142', 'spread': '5.7071', 'groupId': 'OG002'}, {'value': '8.696', 'spread': '3.6468', 'groupId': 'OG003'}, {'value': '6.178', 'spread': '6.4262', 'groupId': 'OG004'}, {'value': '8.877', 'spread': '6.3308', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '29.065', 'spread': '28.1288', 'groupId': 'OG000'}, {'value': '2.710', 'spread': '1.6140', 'groupId': 'OG001'}, {'value': '3.650', 'spread': '2.8445', 'groupId': 'OG002'}, {'value': '4.604', 'spread': '1.3871', 'groupId': 'OG003'}, {'value': '3.190', 'spread': '3.0165', 'groupId': 'OG004'}, {'value': '8.417', 'spread': '7.0440', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21.017', 'spread': '28.4384', 'groupId': 'OG000'}, {'value': '2.642', 'spread': '1.4322', 'groupId': 'OG001'}, {'value': '3.304', 'spread': '5.8018', 'groupId': 'OG002'}, {'value': '5.115', 'spread': '3.5382', 'groupId': 'OG003'}, {'value': '4.042', 'spread': '6.1199', 'groupId': 'OG004'}, {'value': '6.579', 'spread': '4.4134', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '16.811', 'spread': '26.3922', 'groupId': 'OG000'}, {'value': '7.532', 'spread': '13.0615', 'groupId': 'OG001'}, {'value': '2.750', 'spread': '2.9068', 'groupId': 'OG002'}, {'value': '5.014', 'spread': '2.8480', 'groupId': 'OG003'}, {'value': '10.998', 'spread': '17.3463', 'groupId': 'OG004'}, {'value': '7.595', 'spread': '7.9870', 'groupId': 'OG005'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '24.958', 'spread': '29.4450', 'groupId': 'OG000'}, {'value': '3.570', 'spread': '2.1907', 'groupId': 'OG001'}, {'value': '2.445', 'spread': '1.8315', 'groupId': 'OG002'}, {'value': '3.093', 'spread': '0.5652', 'groupId': 'OG003'}, {'value': '14.500', 'spread': '19.2882', 'groupId': 'OG004'}, {'value': '11.734', 'spread': '11.4627', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and in 24, 72 hours, on Days 5, 6, 15, 29 and 45 after the initiation of treatment with the test drug', 'description': 'Change in the serum rate of high-sensitive CRP (hs-CRP) in 24, 72 hours, on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug compared to baseline', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of valid observations is presented.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 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daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '13493.687', 'spread': '14565.0449', 'groupId': 'OG000'}, {'value': '2516.606', 'spread': '1367.7981', 'groupId': 'OG001'}, {'value': '16764.020', 'spread': '14525.1072', 'groupId': 'OG002'}, {'value': '16168.130', 'spread': '12937.7377', 'groupId': 'OG003'}, {'value': '16291.605', 'spread': '17949.6741', 'groupId': 'OG004'}, {'value': '5033.151', 'spread': '3384.3761', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '17424.060', 'spread': '17167.2073', 'groupId': 'OG000'}, {'value': '11078.300', 'spread': '19281.3822', 'groupId': 'OG001'}, {'value': '20104.555', 'spread': '15608.3760', 'groupId': 'OG002'}, {'value': '15581.486', 'spread': '13271.7115', 'groupId': 'OG003'}, {'value': '3659.778', 'spread': '3244.2099', 'groupId': 'OG004'}, {'value': '7294.631', 'spread': '5163.5001', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '17588.735', 'spread': '16623.4301', 'groupId': 'OG000'}, {'value': '1171.203', 'spread': '400.3851', 'groupId': 'OG001'}, {'value': '12162.612', 'spread': '12060.2753', 'groupId': 'OG002'}, {'value': '14419.760', 'spread': '11828.2546', 'groupId': 'OG003'}, {'value': '10596.423', 'spread': '16813.3253', 'groupId': 'OG004'}, {'value': '7362.322', 'spread': '9834.7459', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '17360.201', 'spread': '15874.5237', 'groupId': 'OG000'}, {'value': '1195.975', 'spread': '393.6981', 'groupId': 'OG001'}, {'value': '5680.190', 'spread': '5708.9022', 'groupId': 'OG002'}, {'value': '8228.272', 'spread': '7624.1329', 'groupId': 'OG003'}, {'value': '5952.460', 'spread': '10455.6856', 'groupId': 'OG004'}, {'value': '8252.633', 'spread': '8121.6203', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18553.955', 'spread': '15454.2373', 'groupId': 'OG000'}, {'value': '1847.923', 'spread': '1646.0125', 'groupId': 'OG001'}, {'value': '4781.173', 'spread': '6120.5728', 'groupId': 'OG002'}, {'value': '5799.608', 'spread': '5562.9980', 'groupId': 'OG003'}, {'value': '6117.777', 'spread': '8569.9756', 'groupId': 'OG004'}, {'value': '6165.779', 'spread': '5356.4841', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9272.782', 'spread': '11297.9676', 'groupId': 'OG000'}, {'value': '1525.612', 'spread': '502.8845', 'groupId': 'OG001'}, {'value': '8899.982', 'spread': '17399.0042', 'groupId': 'OG002'}, {'value': '4582.338', 'spread': '5995.5993', 'groupId': 'OG003'}, {'value': '2732.598', 'spread': '1325.3698', 'groupId': 'OG004'}, {'value': '6031.146', 'spread': '10261.9489', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8918.439', 'spread': '12001.1492', 'groupId': 'OG000'}, {'value': '4255.756', 'spread': '6845.1947', 'groupId': 'OG001'}, {'value': '1645.107', 'spread': '1044.8811', 'groupId': 'OG002'}, {'value': '3626.702', 'spread': '2740.1283', 'groupId': 'OG003'}, {'value': '3618.843', 'spread': '3147.2319', 'groupId': 'OG004'}, {'value': '3779.410', 'spread': '2727.9500', 'groupId': 'OG005'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '13858.845', 'spread': '16512.5575', 'groupId': 'OG000'}, {'value': '2086.198', 'spread': '2799.5039', 'groupId': 'OG001'}, {'value': '1269.680', 'spread': '695.3511', 'groupId': 'OG002'}, {'value': '1567.040', 'spread': '1421.4541', 'groupId': 'OG003'}, {'value': '9885.230', 'spread': '15228.9607', 'groupId': 'OG004'}, {'value': '7289.553', 'spread': '7189.8429', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and in 24, 72 hours and on Day 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the rate of serum amyloid protein A in 24, 72 hours and on Day 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of valid observations is presented.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Serum Rates of Cytokines: IL-1α', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.090', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '1.752', 'spread': '1.5390', 'groupId': 'OG003'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.090', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '1.097', 'spread': '0.0163', 'groupId': 'OG002'}, {'value': '1.782', 'spread': '1.5474', 'groupId': 'OG003'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.090', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '1.688', 'spread': '1.3372', 'groupId': 'OG003'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.090', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '1.790', 'spread': '1.5652', 'groupId': 'OG003'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.090', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '1.612', 'spread': '1.1672', 'groupId': 'OG003'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.132', 'spread': '0.1525', 'groupId': 'OG000'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.097', 'spread': '0.0258', 'groupId': 'OG000'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.090', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '1.090', 'spread': '0.0000', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of IL-1α in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of valid observations is presented. (IL-1a values \\<1.10 were replaced with 1.09 for graphical representation and statistical analysis.)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Serum Rates of Cytokines: IL-1β', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '39.035', 'spread': '138.5078', 'groupId': 'OG000'}, {'value': '1.080', 'spread': '1.9351', 'groupId': 'OG001'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.558', 'spread': '3.5248', 'groupId': 'OG003'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '33.885', 'spread': '128.9519', 'groupId': 'OG000'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '1.100', 'spread': '1.8112', 'groupId': 'OG003'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '33.759', 'spread': '128.9859', 'groupId': 'OG000'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.112', 'spread': '4.0741', 'groupId': 'OG003'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '33.753', 'spread': '128.9873', 'groupId': 'OG000'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '33.998', 'spread': '128.9231', 'groupId': 'OG000'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.362', 'spread': '4.6331', 'groupId': 'OG003'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '38.730', 'spread': '138.5974', 'groupId': 'OG000'}, {'value': '1.222', 'spread': '2.0840', 'groupId': 'OG001'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '1.965', 'spread': '3.3500', 'groupId': 'OG003'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '33.811', 'spread': '128.9724', 'groupId': 'OG000'}, {'value': '1.320', 'spread': '2.3032', 'groupId': 'OG001'}, {'value': '0.417', 'spread': '0.3103', 'groupId': 'OG002'}, {'value': '1.746', 'spread': '3.2557', 'groupId': 'OG003'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.290', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '0.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of IL-1β in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of valid observations is presented. (IL-1β \\<0.30 values were replaced with 0.29, IL-1β \\> 500.00 values were replaced with 500.01 for graphical presentation and statistical analysis.)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2400.500', 'spread': '1495.1100', 'groupId': 'OG000'}, {'value': '1448.978', 'spread': '527.8658', 'groupId': 'OG001'}, {'value': '1671.010', 'spread': '1225.2673', 'groupId': 'OG002'}, {'value': '2240.155', 'spread': '937.1988', 'groupId': 'OG003'}, {'value': '2619.456', 'spread': '2706.3397', 'groupId': 'OG004'}, {'value': '2090.721', 'spread': '1240.5717', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1700.180', 'spread': '1448.4981', 'groupId': 'OG000'}, {'value': '229.842', 'spread': '291.9887', 'groupId': 'OG001'}, {'value': '153.098', 'spread': '145.3780', 'groupId': 'OG002'}, {'value': '29.990', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '29.990', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2483.891', 'spread': '1786.0361', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1295.743', 'spread': '916.8659', 'groupId': 'OG000'}, {'value': '156.216', 'spread': '110.6281', 'groupId': 'OG001'}, {'value': '140.108', 'spread': '123.8956', 'groupId': 'OG002'}, {'value': '157.654', 'spread': '227.2334', 'groupId': 'OG003'}, {'value': '29.990', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2297.651', 'spread': '1361.7429', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1364.993', 'spread': '1106.8245', 'groupId': 'OG000'}, {'value': '187.223', 'spread': '109.9846', 'groupId': 'OG001'}, {'value': '154.463', 'spread': '124.6690', 'groupId': 'OG002'}, {'value': '87.214', 'spread': '79.7269', 'groupId': 'OG003'}, {'value': '29.990', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2417.991', 'spread': '1416.8428', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1407.230', 'spread': '927.8243', 'groupId': 'OG000'}, {'value': '214.610', 'spread': '125.9518', 'groupId': 'OG001'}, {'value': '203.688', 'spread': '133.0562', 'groupId': 'OG002'}, {'value': '180.492', 'spread': '112.2664', 'groupId': 'OG003'}, {'value': '29.990', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2426.761', 'spread': '1452.6687', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1620.332', 'spread': '935.4363', 'groupId': 'OG000'}, {'value': '374.900', 'spread': '96.9459', 'groupId': 'OG001'}, {'value': '474.542', 'spread': '214.5880', 'groupId': 'OG002'}, {'value': '645.085', 'spread': '300.6542', 'groupId': 'OG003'}, {'value': '257.492', 'spread': '166.0738', 'groupId': 'OG004'}, {'value': '2249.794', 'spread': '1459.3243', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1928.417', 'spread': '1048.0875', 'groupId': 'OG000'}, {'value': '563.892', 'spread': '142.6097', 'groupId': 'OG001'}, {'value': '583.062', 'spread': '269.1237', 'groupId': 'OG002'}, {'value': '686.992', 'spread': '305.9470', 'groupId': 'OG003'}, {'value': '471.178', 'spread': '267.8262', 'groupId': 'OG004'}, {'value': '1870.815', 'spread': '1032.8765', 'groupId': 'OG005'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1806.647', 'spread': '858.8185', 'groupId': 'OG000'}, {'value': '915.010', 'spread': '177.2813', 'groupId': 'OG001'}, {'value': '808.212', 'spread': '354.6509', 'groupId': 'OG002'}, {'value': '711.997', 'spread': '285.9941', 'groupId': 'OG003'}, {'value': '518.063', 'spread': '201.1455', 'groupId': 'OG004'}, {'value': '1969.547', 'spread': '1352.6193', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of IL-1RA in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of valid observations is presented. (IL-1RA values \\<30.00 were replaced with 29.99 for graphical representation and statistical analysis.)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Serum Rates of Cytokines: IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '26.035', 'spread': '39.1257', 'groupId': 'OG000'}, {'value': '5.005', 'spread': '4.6022', 'groupId': 'OG001'}, {'value': '34.307', 'spread': '54.3264', 'groupId': 'OG002'}, {'value': '5.623', 'spread': '6.8564', 'groupId': 'OG003'}, {'value': '13.666', 'spread': '11.9695', 'groupId': 'OG004'}, {'value': '6.058', 'spread': '6.9686', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '27.030', 'spread': '42.9908', 'groupId': 'OG000'}, {'value': '2.084', 'spread': '1.8930', 'groupId': 'OG001'}, {'value': '37.788', 'spread': '72.3187', 'groupId': 'OG002'}, {'value': '6.284', 'spread': '11.1153', 'groupId': 'OG003'}, {'value': '9.065', 'spread': '12.5843', 'groupId': 'OG004'}, {'value': '2.361', 'spread': '1.2039', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '14.943', 'spread': '29.9008', 'groupId': 'OG000'}, {'value': '2.236', 'spread': '1.8533', 'groupId': 'OG001'}, {'value': '2.145', 'spread': '0.9961', 'groupId': 'OG002'}, {'value': '3.142', 'spread': '3.7290', 'groupId': 'OG003'}, {'value': '4.698', 'spread': '7.3223', 'groupId': 'OG004'}, {'value': '1.702', 'spread': '1.1067', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '23.999', 'spread': '37.5678', 'groupId': 'OG000'}, {'value': '2.695', 'spread': '2.2949', 'groupId': 'OG001'}, {'value': '2.378', 'spread': '1.9432', 'groupId': 'OG002'}, {'value': '1.396', 'spread': '0.5031', 'groupId': 'OG003'}, {'value': '4.905', 'spread': '7.5114', 'groupId': 'OG004'}, {'value': '1.823', 'spread': '1.6473', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.391', 'spread': '13.3742', 'groupId': 'OG000'}, {'value': '3.565', 'spread': '3.5282', 'groupId': 'OG001'}, {'value': '2.965', 'spread': '3.4991', 'groupId': 'OG002'}, {'value': '1.272', 'spread': '0.3636', 'groupId': 'OG003'}, {'value': '6.220', 'spread': '9.8491', 'groupId': 'OG004'}, {'value': '2.157', 'spread': '2.1250', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '10.595', 'spread': '14.4444', 'groupId': 'OG000'}, {'value': '2.870', 'spread': '1.5838', 'groupId': 'OG001'}, {'value': '2.434', 'spread': '1.7929', 'groupId': 'OG002'}, {'value': '1.793', 'spread': '0.5907', 'groupId': 'OG003'}, {'value': '12.858', 'spread': '25.3149', 'groupId': 'OG004'}, {'value': '2.036', 'spread': '1.2089', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18.643', 'spread': '50.4658', 'groupId': 'OG000'}, {'value': '2.758', 'spread': '1.7315', 'groupId': 'OG001'}, {'value': '3.278', 'spread': '4.2245', 'groupId': 'OG002'}, {'value': '1.482', 'spread': '0.5334', 'groupId': 'OG003'}, {'value': '17.903', 'spread': '31.1335', 'groupId': 'OG004'}, {'value': '5.304', 'spread': '7.4387', 'groupId': 'OG005'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.466', 'spread': '9.1261', 'groupId': 'OG000'}, {'value': '4.608', 'spread': '5.8999', 'groupId': 'OG001'}, {'value': '3.370', 'spread': '4.5051', 'groupId': 'OG002'}, {'value': '1.537', 'spread': '0.3911', 'groupId': 'OG003'}, {'value': '3.753', 'spread': '1.6094', 'groupId': 'OG004'}, {'value': '2.607', 'spread': '1.9663', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of IL-6 in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of valid observations is presented. (IL-6 values \\<0.92 were replaced with 0.913, IL-6 values \\>200.00 were replaced with 200.01 for graphical representation and statistical analysis.)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Serum Rates of Cytokines: IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '12.384', 'spread': '5.8297', 'groupId': 'OG000'}, {'value': '21.964', 'spread': '24.8759', 'groupId': 'OG001'}, {'value': '9.277', 'spread': '4.5347', 'groupId': 'OG002'}, {'value': '18.305', 'spread': '21.8921', 'groupId': 'OG003'}, {'value': '12.318', 'spread': '12.5702', 'groupId': 'OG004'}, {'value': '10.863', 'spread': '7.1505', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.228', 'spread': '7.1217', 'groupId': 'OG000'}, {'value': '9.304', 'spread': '9.7609', 'groupId': 'OG001'}, {'value': '9.030', 'spread': '5.5014', 'groupId': 'OG002'}, {'value': '12.304', 'spread': '9.9136', 'groupId': 'OG003'}, {'value': '2.668', 'spread': '1.3550', 'groupId': 'OG004'}, {'value': '17.141', 'spread': '13.6494', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '15.601', 'spread': '19.4714', 'groupId': 'OG000'}, {'value': '8.708', 'spread': '5.8951', 'groupId': 'OG001'}, {'value': '9.020', 'spread': '6.2030', 'groupId': 'OG002'}, {'value': '5.952', 'spread': '4.4991', 'groupId': 'OG003'}, {'value': '8.148', 'spread': '5.6025', 'groupId': 'OG004'}, {'value': '15.980', 'spread': '11.7350', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '13.521', 'spread': '7.8988', 'groupId': 'OG000'}, {'value': '4.313', 'spread': '2.6941', 'groupId': 'OG001'}, {'value': '8.032', 'spread': '4.9402', 'groupId': 'OG002'}, {'value': '10.518', 'spread': '6.8098', 'groupId': 'OG003'}, {'value': '11.190', 'spread': '4.4376', 'groupId': 'OG004'}, {'value': '15.188', 'spread': '12.3696', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '16.969', 'spread': '16.9723', 'groupId': 'OG000'}, {'value': '8.015', 'spread': '4.6897', 'groupId': 'OG001'}, {'value': '7.937', 'spread': '5.3199', 'groupId': 'OG002'}, {'value': '7.594', 'spread': '5.9449', 'groupId': 'OG003'}, {'value': '10.745', 'spread': '6.3010', 'groupId': 'OG004'}, {'value': '19.881', 'spread': '21.0673', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9.765', 'spread': '9.3536', 'groupId': 'OG000'}, {'value': '20.884', 'spread': '31.6507', 'groupId': 'OG001'}, {'value': '11.520', 'spread': '7.4313', 'groupId': 'OG002'}, {'value': '16.395', 'spread': '19.5556', 'groupId': 'OG003'}, {'value': '3.060', 'spread': '2.3926', 'groupId': 'OG004'}, {'value': '34.770', 'spread': '66.4033', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '19.766', 'spread': '20.8879', 'groupId': 'OG000'}, {'value': '25.622', 'spread': '36.4743', 'groupId': 'OG001'}, {'value': '8.003', 'spread': '6.1368', 'groupId': 'OG002'}, {'value': '8.596', 'spread': '9.2114', 'groupId': 'OG003'}, {'value': '9.243', 'spread': '5.1441', 'groupId': 'OG004'}, {'value': '8.554', 'spread': '7.6207', 'groupId': 'OG005'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '12.664', 'spread': '7.2467', 'groupId': 'OG000'}, {'value': '5.468', 'spread': '4.1120', 'groupId': 'OG001'}, {'value': '5.807', 'spread': '5.8272', 'groupId': 'OG002'}, {'value': '7.223', 'spread': '3.0891', 'groupId': 'OG003'}, {'value': '7.927', 'spread': '5.3051', 'groupId': 'OG004'}, {'value': '11.763', 'spread': '11.1239', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of IL-8 in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of valid observations is presented. (IL-8 values \\<2.00 were replaced with 1.99 for graphical representation and statistical analysis.)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.290', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 2/ 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.290', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 4/ 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.290', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.290', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.290', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.290', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.290', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.290', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '2.290', 'spread': '0.0000', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of TNF-α in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of valid observations is presented. (TNF-α values \\<2.30 were replaced with 2.29 for graphical representation and statistical analysis.)'}, {'type': 'SECONDARY', 'title': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.05', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.82', 'groupId': 'OG003'}, {'value': '1.4', 'spread': '0.55', 'groupId': 'OG004'}, {'value': '1.2', 'spread': '0.97', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-1.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-0.5', 'spread': '0.55', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.82', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\nThe result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst).\n\nIf the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2".', 'unitOfMeasure': 'units of the HAQ index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.'}, {'type': 'SECONDARY', 'title': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.37', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.17', 'groupId': 'OG003'}, {'value': '1.0', 'spread': '1.00', 'groupId': 'OG004'}, {'value': '0.7', 'spread': '1.00', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '0.52', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '0.50', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '0.5', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\nThe result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst).\n\nIf the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2".', 'unitOfMeasure': 'units of the HAQ index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.'}, {'type': 'SECONDARY', 'title': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.75', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '0.82', 'groupId': 'OG003'}, {'value': '1.6', 'spread': '1.14', 'groupId': 'OG004'}, {'value': '1.8', 'spread': '0.67', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-1.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '-0.7', 'spread': '0.82', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '0.50', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '-0.8', 'spread': '0.96', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\nThe result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst).\n\nIf the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2".', 'unitOfMeasure': 'units of the HAQ index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.'}, {'type': 'SECONDARY', 'title': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '1.05', 'groupId': 'OG003'}, {'value': '2.2', 'spread': '0.45', 'groupId': 'OG004'}, {'value': '1.3', 'spread': '0.50', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-2.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '-0.5', 'spread': '0.55', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '-0.5', 'spread': '0.58', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '-1.0', 'spread': '0.82', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\nThe result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst).\n\nIf the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2".', 'unitOfMeasure': 'units of the HAQ index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.'}, {'type': 'SECONDARY', 'title': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'OG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'OG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '1.10', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '1.10', 'groupId': 'OG004'}, {'value': '0.4', 'spread': '0.73', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-0.2', 'spread': '0.41', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '0.5', 'groupId': 'OG005'}]}]}, {'title': 'Change Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'small group size', 'groupId': 'OG003'}, {'value': '-1.0', 'spread': '1.41', 'groupId': 'OG004'}, {'value': '0.3', 'spread': '1.26', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\nThe result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst).\n\nIf the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2".', 'unitOfMeasure': 'units of the HAQ index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'FG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'FG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'FG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'FG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'FG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'closure of city borders because of COVID-19 quarantine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COVID-19 epidemiological situation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment was conducted at 11 clinical sites in Russian Federation. 54 subjects were screened and 47 subjects were enrolled (randomized) and treated, 44 subjects completed the study.\n\nThe Safety Population and Efficacy Population included data from all 47 randomized patients to assess safety, treatment efficacy and pharmacodynamics.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'RPH - 4 mg', 'description': 'RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'BG001', 'title': 'RPH - 20 mg', 'description': 'RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'BG002', 'title': 'RPH - 40 mg', 'description': 'RPH-104, 40 mg, subcutaneous single-dose injection.\n\n1 mL of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'BG003', 'title': 'RPH - 80 mg', 'description': 'RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected.'}, {'id': 'BG004', 'title': 'RPH - 160 mg', 'description': 'RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.\n\n1 vial of 2mL 40 mg/mL solution per each site'}, {'id': 'BG005', 'title': 'Voltaren® (Diclofenac)', 'description': 'Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '63'}, {'value': '51.7', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '60'}, {'value': '42.8', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '57'}, {'value': '56.5', 'groupId': 'BG003', 'lowerLimit': '41', 'upperLimit': '78'}, {'value': '53.6', 'groupId': 'BG004', 'lowerLimit': '50', 'upperLimit': '59'}, {'value': '52.2', 'groupId': 'BG005', 'lowerLimit': '42', 'upperLimit': '61'}, {'value': '51.5', 'groupId': 'BG006', 'lowerLimit': '31', 'upperLimit': '78'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Caucasian/White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}]}, {'title': 'other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease duration', 'classes': [{'categories': [{'measurements': [{'value': '8.13', 'groupId': 'BG000', 'lowerLimit': '0.9', 'upperLimit': '17.2'}, {'value': '7.65', 'groupId': 'BG001', 'lowerLimit': '0.1', 'upperLimit': '17.3'}, {'value': '8.04', 'groupId': 'BG002', 'lowerLimit': '2.4', 'upperLimit': '19.4'}, {'value': '9.16', 'groupId': 'BG003', 'lowerLimit': '0.9', 'upperLimit': '15.9'}, {'value': '13.55', 'groupId': 'BG004', 'lowerLimit': '7.4', 'upperLimit': '29.3'}, {'value': '6.41', 'groupId': 'BG005', 'lowerLimit': '0.1', 'upperLimit': '12.5'}, {'value': '8.82', 'groupId': 'BG006', 'lowerLimit': '0.1', 'upperLimit': '29.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Exact number of affected joints', 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '23'}, {'value': '3.0', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '5.7', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '25'}, {'value': '2.7', 'groupId': 'BG003', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '6.2', 'groupId': 'BG004', 'lowerLimit': '2', 'upperLimit': '16'}, {'value': '3.0', 'groupId': 'BG005', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '4.32', 'groupId': 'BG006', 'lowerLimit': '1', 'upperLimit': '25'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number (of joints)', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-19', 'size': 2490560, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-01T07:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'whyStopped': 'In view of the continuing insufficient patient recruitment in the study due to the difficult epidemiological situation and the need for rational allocation of company resources, as well as based on the results of the interim analysis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2019-08-05', 'resultsFirstSubmitDate': '2022-03-23', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-23', 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pharmacokinetics (PK) - Area Under the Plasma concentration-of RPH-104 Under the Subcutaneous Administration', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including area under the plasma concentration-time curve over the dosing interval (AUC0-tau)'}, {'measure': 'Pharmacokinetics (PK) - Area Under the Active Substance Concentration- of RPH-104 Under the Subcutaneous Administration', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including Area under the active substance concentration-time curve from zero (before drug administration) to infinity (AUC0-∞)'}, {'measure': 'Pharmacokinetics (PK) - Maximum Concentration of the Active Substance -of RPH-104 Under the Subcutaneous Administration', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including Maximum concentration of the active substance (Cmax)'}, {'measure': 'Pharmacokinetics (PK) of RPH-104 Under the Subcutaneous Administration', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including elimination constant (Kel)'}, {'measure': 'Pharmacokinetics (PK) -Time to Reach Maximum Concentration of the Active Substance - of RPH-104 Under the Subcutaneous Administration', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including Time to reach maximum concentration of the active substance (tmax)'}, {'measure': 'Pharmacokinetics (PK) - Terminal Half-life -of RPH-104 Under the Subcutaneous Administration', 'timeFrame': 'Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)', 'description': 'Including terminal half-life (T 1/2)'}, {'measure': 'Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes', 'timeFrame': 'Baseline and in 24, 72 hours, on Days 5, 6, 15, 29 and 45 after the initiation of treatment with the test drug', 'description': 'Change in the serum rate of high-sensitive CRP (hs-CRP) in 24, 72 hours, on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug compared to baseline'}, {'measure': 'Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes', 'timeFrame': 'Baseline and in 24, 72 hours and on Day 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the rate of serum amyloid protein A in 24, 72 hours and on Day 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline'}, {'measure': 'Change in the Serum Rates of Cytokines: IL-1α', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of IL-1α in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline'}, {'measure': 'Change in the Serum Rates of Cytokines: IL-1β', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of IL-1β in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline'}, {'measure': 'Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA)', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of IL-1RA in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline'}, {'measure': 'Change in the Serum Rates of Cytokines: IL-6', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of IL-6 in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline'}, {'measure': 'Change in the Serum Rates of Cytokines: IL-8', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of IL-8 in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline'}, {'measure': 'Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α)', 'timeFrame': 'Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the serum rates of TNF-α in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline'}], 'primaryOutcomes': [{'measure': 'Change in Pain Intensity in the Assessed Joint 72 Hours After the Initiation of Treatment in Comparison to Baseline', 'timeFrame': 'Baseline and Day 4 (72 hours after the initiation of treatment with the test drug)', 'description': 'Change in pain intensity in the assessed joint 72 hours after the initiation of treatment with the test drug measured using the Visual Analogue Scale (VAS) in comparison to baseline. VAS is a hard copy 100 mm scale with the indications: "Absence of pain" on the left side of the scale (0 mm point) and "The most severe pain ever experienced" on the right side of the scale (100 mm point)) The better outcome would be "Absence of pain", the worse outcome would be "The most severe pain ever experienced".'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline', 'timeFrame': 'Baseline and 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment', 'description': 'Change in pain intensity in the assessed joint in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug measured using the Visual Analogue Scale (VAS) and compared to baseline. VAS is a hard copy 100 mm scale with the indications: "Absence of pain" on the left side of the scale (0 mm point) and "The most severe pain ever experienced" on the right side of the scale (100 mm point)) The better outcome would be "Absence of pain", the worse outcome would be "The most severe pain ever experienced".'}, {'measure': 'Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as "Excellent" or "Good"', 'timeFrame': '15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment with the test drug', 'description': 'Proportion of patients who assessed the response to therapy with the test drug as "Excellent" or "Good" in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug.\n\nThe patient\'s response to therapy was assessed in the form of frequency tables by assessment point and therapy group. The rates of the response were specified in the evaluation form as: "Excellent", "Good", "Fair", "Weak", "Poor" (where "excellent" represents the best possible response to treatment and "poor" indicates the worst treatment response).'}, {'measure': 'Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug', 'timeFrame': 'Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the rate of swelling of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. The rates of swelling were specified in the evaluation form as: "absence" = no swelling, "mild" = palpable swelling, "moderate" = visible swelling, "severe" = bulging outside the joint (where "severe" represented the worst possible degree of swelling and "absence" was the best outcome).'}, {'measure': 'Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug', 'timeFrame': 'Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the rate of tenderness of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. Tenderness degrees: "absent" = no tenderness, "mild" = tenderness when touched, "moderate" = pain and flinching, "severe" = pain, flinching and withdrawal of the limb (where "severe" represents the worst possible degree of tenderness and "absent" is the best outcome).'}, {'measure': 'Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug', 'timeFrame': 'Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the rate of erythema of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline.The rates of "erythema" were specified as "absence", "presence", "impossible to evaluate".'}, {'measure': 'Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment', 'timeFrame': 'Baseline and in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug', 'description': 'Change in the rate of movement restrictions in the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. For the assessment, the categorical scale consistent with the Form for evaluation (Investigator\'s Assessment) of the restriction of movements was used. The rates of movement restrictions (amplitude of movements) were specified in the evaluation form as "1 - Normal range", "2 - Slightly limited range", " 3 - Moderately limited range" ,"4 - Severely limited range" and "5 - Joint movement is impossible " (where higher score means worse outcome).'}, {'measure': 'Time to Achieve the 50% Decrease in Pain Intensity in the Assessed Joint Relative to the Baseline', 'timeFrame': 'Baseline and one of the pain intensity measurements in accordance with the schedule: 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment', 'description': 'Time to achieve the 50% decrease in pain intensity in the assessed joint relative to the baseline VAS level.\n\nVAS is a hard copy 100 mm scale with the indications: "Absence of pain" on the left side of the scale (0 mm point) and "The most severe pain ever experienced" on the right side of the scale (100 mm point)). The better outcome would be "Absence of pain", the worse outcome would be "The most severe pain ever experienced".'}, {'measure': 'Time to Use of the Rescue Medication', 'timeFrame': 'from the date/time of IP administration (first dose) to the date/time of the first use of the rescue medication, up to day 60', 'description': 'Time to use of the rescue medication was calculated as the time in hours from the date/time of administration (first dose) of the investigational product to the date/time of the first use of the rescue medication.'}, {'measure': 'Proportion of Patients Who Received a Rescue Therapy Agent', 'timeFrame': '72 hours after the initiation of treatment with the test drug', 'description': 'The proportion of patients who received the rescue medication within 72 hours of starting the investigational product therapy'}, {'measure': 'Proportion of Patients Who Received a Rescue Therapy Agent', 'timeFrame': 'up to day 60', 'description': 'The proportion of patients who received the rescue medication over the entire treatment period'}, {'measure': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\n(The result for each of the 8 categories ("Dressing and Grooming", "Arising", "Eating", "Walking", "Hygiene", "Reach", "Grip", "Activities") of the HAQ questionnaire was calculated as the maximum score of responses (on an ordinal scale from 0 (best) to 3 (worst): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3)) to questions included in this category. If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2". The sum of points for the evaluated categories was calculated and divided by the number of categories, which gives a disability index in the range of 0 to 3.)'}, {'measure': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\nThe result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst).\n\nIf the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2".'}, {'measure': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\nThe result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst).\n\nIf the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2".'}, {'measure': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\nThe result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst).\n\nIf the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2".'}, {'measure': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\nThe result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst).\n\nIf the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2".'}, {'measure': 'Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip', 'timeFrame': 'Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug', 'description': 'Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline.\n\nThe result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst).\n\nIf the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned "2" points, if the point was not equal to "3", i.e. points "0" and "1" increased to "2".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyperuricemia', 'acute arthritis', 'gouty arthritis', 'gout'], 'conditions': ['Gout Attack']}, 'descriptionModule': {'briefSummary': 'The primary goal of the study was to evaluate the parameters of efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of RPH-104 in adult patients with acute gout attack.', 'detailedDescription': 'The study consisted of two periods:\n\nPeriod 1. In Study Period 1, eligible patients were enrolled in a group of 22 patients and randomized to receive either RPH-104 4 mg or Voltaren® (diclofenac) in the 15:7 ratio (15 RPH-104: 7 Voltaren® (diclofenac)). In order to prevent damage to the gastric and duodenal mucosa caused by Voltaren® (diclofenac), all patients receiving Voltaren® (diclofenac) had to simultaneously take Ortanol® (omeprazole) 20 mg, orally (1 capsule) daily before breakfast throughout the course of Voltaren® (diclofenac) treatment\n\nPeriod 2. Upon completion of the enrollment of 22 patients, Study Period 2 started. In Period 2, newly enrolled patients were randomly assigned to one of 5 treatment groups: RPH-104 20 mg, 40 mg, 80 mg and 160 mg and active control (Voltaren® (diclofenac)). It was planned to include 14 patients in the RPH-104 groups in Period 2, and 7 patients in the Voltaren® (diclofenac) group.\n\nThe enrollment of patients in Period 1 and Period 2 was sequential. There was no pause between the enrollment of patients in Period 1 and Period 2. The study design included screening (24 hours), 11 visits to the study site, and a phone call at the end of the 60-day follow-up period.\n\nTotal number of patients which were planned to be enrolled for the study: 85 (15 patients in the group of treatment with RPH-104 4 mg and 14 patients in the each of the other treatment groups). Due to the low patient recruitment rate in the study and the negative impact of the COVID-19 pandemic on the recruitment, at the decision of the sponsor, an interim analysis of the data of 47 patients included in the study as of November 2020 was carried out in order to assess the feasibility of continuing recruitment and further conducting the study.\n\nPatients who did not tolerate pain were allowed to receive a rescue medication, triamcinolone acetonide 40 mg intramuscularly, to intensify therapy 2 hours after the test product was administered. If the attack recurred after the use of the rescue medication, treatment was carried out in accordance with the standard practice of the hospital.\n\nThe primary efficacy endpoints were evaluated 72 hours after the end of administration of the test drug. The secondary efficacy endpoints were evaluated for 45 days of the treatment period and follow-up. The safety parameters were evaluated for 60 days of the treatment period and follow-up. Total duration of the study for a volunteer was not more than 70 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. The subject has given his / her informed consent to participate in this study; the Informed Consent Form has been signed both by the patient and the Investigator;\n* 2\\. Established diagnosis of gout according to Gout Classification Criteria established by the American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) in 2015;\n* 3\\. Pain in at least one joint at the screening and immediately prior to initiation of therapy with the study drugs, with intensity 50 mm to 100 mm according to the Visual Analogue Scale (VAS);\n* 4\\. Development of acute gout attack within 120 hours (5 days) prior to the randomization date;\n* 5\\. History of 1 or more acute gout attacks prior to the Screening Visit;\n* 6.The patients receiving uric acid-lowering drugs should continue receiving these drugs at a constant dose for at least 4 weeks prior to enrolment to the study and throughout the entire study period; the patients not receiving uric acid-lowering drugs may start receiving this treatment after the end of the study;\n* 7\\. Body mass index ≤40 kg/m2;\n* 8\\. QTcF interval ≤450 msec for male subjects and ≤470 msec for females on ECG at the screening;\n* 9\\. For women of child-bearing potential: negative result of the serum pregnancy test performed at the screening;\n* 10\\. The consent of a woman of child-bearing potential, as well as of a man who has female partners of child-bearing potential, to abstain from sexual intercourses or to use effective birth control methods throughout the entire study period and for 60 days after RPH-104 administration (if the patient received RPH-104);\n* 11\\. The patient is able to fulfil the requirements of the Study Protocol as judged by the Investigator\n\nExclusion Criteria:\n\n* 1\\. The patient received therapy with ibuprofen in a dose of up to 400 mg inclusive within 4 hours or \\>400 mg within 8 hours prior to randomization.\n* 2\\. The patient received therapy with diclofenac in a dose of up to 50 mg inclusive within 8 hours or \\>50 mg within 24 hours prior to randomization.\n* 3\\. The patient received any other non-steroidal anti-inflammatory drug (NSAID) within 24 hours prior to the randomization;\n* 4.The patient received opioids within 48 hours prior to the randomization;\n* 5\\. The patient received metamizole or metamizole-containing drugs within 12 hours prior to the randomization;\n* 6\\. The patient received any drug with analgesic activity (including paracetamol) within 6 hours prior to the randomization;\n* 7\\. The patient received a long-acting NSAID (half-life ≥24 hours) within 5 half-life periods or 1 month prior to the randomization whichever is longer;\n* 8\\. The patient received extended-release naproxen, meloxicam, nabumetone, celecoxib, etoricoxib or indomethacin within 5 days prior to the randomization;\n* 9 . The patient received corticosteroids (including their intra-articular administration and inhalations) within 4 weeks prior to the randomization;\n* 10\\. The patient received colchicine within 7 days prior to the randomization;\n* 11\\. Intolerance or contraindications for NSAID use;\n* 12\\. Contraindications for the use of Ortanol® capsules 20 mg;\n* 13\\. Chronic heart failure functional class II-IV (classification of NYHA);\n* 14\\. A history of or current clinically significant ventricular arrhythmias or clinically significant atrial tachyarrhythmias;\n* 15\\. Unstable angina or stable exercise-induced angina of functional class III or IV;\n* 16\\. Secondary gout, chemotherapy-induced gout, lead- or transplantation-induced gout;\n* 17\\. Rheumatoid arthritis, confirmed or suspected infectious septic arthritis or any other type of acute inflammatory arthritis;\n* 18\\. Clinically significant renal impairment determined based on creatinine clearance (estimated using the Cockcroft-Gault equation) \\<60 mL/min, or patients on hemodialysis;\n* 19\\. Blood coagulation disorders; history of gastrointestinal bleedings or perforation;\n* 20\\. Pregnant or breast-feeding women;\n* 21\\. Elective surgery or major surgical intervention (minor surgical procedures, such as catheter placement or bone marrow biopsy, are not exclusion criteria) within 14 days before the first dose of the investigational medicinal product;\n* 22\\. Current or suspected HIV-infection, HBsAg, Hepatitis C Virus antibodies (HCVAb), other acute or chronic bacterial, fungal or viral infections at the moment of subject's enrolment to the study;\n* 23\\. Presence of any risk factors for tuberculosis based on the results of assessment using Tuberculosis Risk Assessment Questionnaire at the screening or confirmed tuberculosis or any other infectious disease of the lungs or bronchi based on findings of the chest X-ray exam in two views performed within 3 months prior to the screening visit, or the need for using therapy with tuberculosis medications, such as isoniazid in the course of the study;\n* 24\\. Neutropenia, leukopenia, or thrombocytopenia determined based on the following laboratory parameters assessed during the screening:\n\n 1. Absolute neutrophil count (ANC) \\<1.5 x 10\\^9/L;\n 2. White blood cell count \\<4.0 х 10\\^9/L\n 3. Platelet count \\<150 х 10\\^9/L;\n* 25\\. Immunization with live vaccines within 3 months prior to the subject's enrolment to the study or planned vaccination within 60 days after the expected date of the first dose of the test drug;\n* 26\\. History of allergic reactions to biologicals, Voltaren® (diclofenac) or Ortanol® (omeprazole);\n* 27\\. Contraindications for subcutaneous, intramuscular, intravenous or intra-articular injections;\n* 28\\. History of malignancy (except for patients with localized in situ basal cell carcinoma of the skin or in situ cervical cancer, who can be enrolled to the study immediately after the therapy for this disease), unless it is in remission for ≥5 years, as well as patients who are being examined for cancer or patients with suspected malignancy;\n* 29\\. A condition or disease, which, in the Investigator's opinion, could put the patient's safety at risk or affect the test drug safety assessment;\n* 30\\. Any other conditions and diseases, such as uncontrolled diabetes mellitus, uncontrolled hypertension, congestive heart failure, exacerbation of peptic ulcer disease, clinically significant liver diseases, kidney diseases, uncontrolled thyroid dysfunction, unhealed wounds, ulcers or bone fractures, psychiatric disorders, uncontrolled epilepsy, drug dependence, which could prevent the patient from complying with this Study Protocol.\n* 31\\. The patient received biologicals or investigational medicinal products within 5 half-life periods of these drugs or 3 month prior to the randomization whichever is longer;\n* 32\\. Blood donation or blood loss of ≥400 mL within 8 weeks prior to the randomization.\n* 33\\. The patient was already randomized in this clinical study."}, 'identificationModule': {'nctId': 'NCT04067492', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack', 'organization': {'class': 'INDUSTRY', 'fullName': 'R-Pharm'}, 'officialTitle': 'An Open-label, Single-dose, Active-controlled Randomized Phase IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RPH-104 (RPH-104/L04018) Administered at Different Doses to Patients With Acute Gout Attack', 'orgStudyIdInfo': {'id': 'CL04018054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RPH - 4 mg', 'description': 'Subjects randomized to receive RPH-104, 4 mg, subcutaneous single-dose injection. In order to administer RPH-104 at the dose of 4 mg, 0.1 mL of RPH-104 solution is injected.', 'interventionNames': ['Drug: RPH - 104']}, {'type': 'EXPERIMENTAL', 'label': 'RPH - 20 mg', 'description': 'Subjects randomized to receive RPH-104, 20 mg, subcutaneous single-dose injection. In order to administer RPH-104 at the dose of 20 mg, 0.5 mL of RPH-104 solution is injected.', 'interventionNames': ['Drug: RPH - 104']}, {'type': 'EXPERIMENTAL', 'label': 'RPH - 40 mg', 'description': 'Subjects randomized to receive RPH-104, 40 mg, subcutaneous single-dose injection. In order to administer RPH-104 at the dose of 40 mg, 1 mL of RPH-104 solution is injected.', 'interventionNames': ['Drug: RPH - 104']}, {'type': 'EXPERIMENTAL', 'label': 'RPH - 80 mg', 'description': 'Subjects randomized to receive RPH-104, 80 mg, subcutaneous single-dose injection. In order to administer RPH-104 at the dose of 80 mg, 2 mL (whole vial) of RPH-104 solution is injected.', 'interventionNames': ['Drug: RPH - 104']}, {'type': 'EXPERIMENTAL', 'label': 'RPH - 160 mg', 'description': 'Subjects randomized to receive RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites. (1 vial of 2mL solution per each site)', 'interventionNames': ['Drug: RPH - 104']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voltaren® (diclofenac)', 'description': 'Subjects randomized to receive Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose)', 'interventionNames': ['Drug: Voltaren®']}], 'interventions': [{'name': 'RPH - 104', 'type': 'DRUG', 'description': 'solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial', 'armGroupLabels': ['RPH - 160 mg', 'RPH - 20 mg', 'RPH - 4 mg', 'RPH - 40 mg', 'RPH - 80 mg']}, {'name': 'Voltaren®', 'type': 'DRUG', 'otherNames': ['Diclofenac'], 'description': 'Enteric-coated tablets, 25 mg and 50 mg', 'armGroupLabels': ['Voltaren® (diclofenac)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111539', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow City State Healthcare Institution "O.M. Filatov Municipal Clinical Hospital No. 15" of the Moscow Department of Healthcare', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119049', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution of Moscow City "Municipal Clinical Hospital No.1 named after N.I. Pirogov" of Moscow Department of Healthcare', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Autonomous Educational Institution of Higher Education "I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123182', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution of Moscow City "Municipal Clinical Hospital No.52" of Moscow Department of Healthcare', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603018', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'State Budgetary Institution of Healthcare of Nizhny Novgorod region "City Clinical hospital #13 of Avozavodskiy district"', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '460000', 'city': 'Orenburg', 'country': 'Russia', 'facility': 'Federal State Budgetary Education Institution of Higher Education "Orenburg State Medical University" under Ministry of Healthcare of Russian Federation', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'zip': '190068', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg State Budgetary Healthcare Institution "Clinical Rheumatological Hospital No.25"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '192242', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'State Budget Institution "Saint Petersburg Research Insitute of emergency care named after I.I. Dzhanelidze', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196143', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Limited Liability company "Scientific Research Center Eco-safety"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '300053', 'city': 'Tula', 'country': 'Russia', 'facility': 'State Insitution of healthcare "Tula regional clinical dermatovenerologic dispensary"', 'geoPoint': {'lat': 54.19609, 'lon': 37.61822}}, {'zip': '150003', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'State Autonomous Healthcare Institution of the Yaroslavl Region "N.V. Solovyev Clinical Emergency Hospital"', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}], 'overallOfficials': [{'name': 'Mikhail Samsonov', 'role': 'STUDY_DIRECTOR', 'affiliation': 'R-Pharm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R-Pharm', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Covance', 'class': 'INDUSTRY'}, {'name': 'Unimed Laboratories', 'class': 'INDUSTRY'}, {'name': 'Data Matrix Solutions', 'class': 'OTHER'}, {'name': 'Center of Pharmaceutical Analytics LLC', 'class': 'INDUSTRY'}, {'name': 'OCT LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}