Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-24 @ 10:54 AM
Study NCT ID:
NCT04123405
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2019-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096825', 'term': 'Rhinosinusitis'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.', 'description': 'Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)', 'otherNumAtRisk': 235, 'deathsNumAtRisk': 235, 'otherNumAffected': 9, 'seriousNumAtRisk': 235, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)', 'otherNumAtRisk': 238, 'deathsNumAtRisk': 238, 'otherNumAffected': 15, 'seriousNumAtRisk': 238, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)', 'otherNumAtRisk': 238, 'deathsNumAtRisk': 238, 'otherNumAffected': 15, 'seriousNumAtRisk': 238, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).', 'otherNumAtRisk': 233, 'deathsNumAtRisk': 233, 'otherNumAffected': 8, 'seriousNumAtRisk': 233, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Ear congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Otitis media bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinusitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Human chorionic gonadotropin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasal crusting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.8213', 'spread': '1.98247', 'groupId': 'OG000'}, {'value': '-4.7394', 'spread': '1.99090', 'groupId': 'OG001'}, {'value': '-4.7758', 'spread': '1.96938', 'groupId': 'OG002'}, {'value': '-5.0180', 'spread': '1.98262', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.\n\nMean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.9085', 'spread': '1.92431', 'groupId': 'OG000'}, {'value': '-4.8688', 'spread': '1.84448', 'groupId': 'OG001'}, {'value': '-4.8002', 'spread': '1.90569', 'groupId': 'OG002'}, {'value': '-5.1256', 'spread': '1.95072', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.\n\nMean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Action, Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'There was no statistically significant improvement of the drug from placebo on any day', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'There was no statistically significant improvement of the drug from placebo on any day', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'There was no statistically significant improvement of the drug from placebo on any day', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value\\<0.05) improvement from placebo.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Action, Per-Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'There was no statistically significant improvement of the drug from placebo on any day', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'There was no statistically significant improvement of the drug from placebo on any day', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'There was no statistically significant improvement of the drug from placebo on any day', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value\\<0.05) improvement from placebo.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'title': 'Day 1 (Baseline)', 'categories': [{'measurements': [{'value': '9.634', 'spread': '1.1181', 'groupId': 'OG000'}, {'value': '9.640', 'spread': '1.0647', 'groupId': 'OG001'}, {'value': '9.702', 'spread': '1.0101', 'groupId': 'OG002'}, {'value': '9.683', 'spread': '1.0652', 'groupId': 'OG003'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '9.021', 'spread': '2.0348', 'groupId': 'OG000'}, {'value': '9.004', 'spread': '1.9883', 'groupId': 'OG001'}, {'value': '9.038', 'spread': '2.1235', 'groupId': 'OG002'}, {'value': '9.074', 'spread': '1.9866', 'groupId': 'OG003'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '8.485', 'spread': '2.3376', 'groupId': 'OG000'}, {'value': '8.513', 'spread': '2.2303', 'groupId': 'OG001'}, {'value': '8.416', 'spread': '2.4390', 'groupId': 'OG002'}, {'value': '8.609', 'spread': '2.1298', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '7.821', 'spread': '2.4482', 'groupId': 'OG000'}, {'value': '7.695', 'spread': '2.5130', 'groupId': 'OG001'}, {'value': '7.723', 'spread': '2.7156', 'groupId': 'OG002'}, {'value': '7.761', 'spread': '2.5058', 'groupId': 'OG003'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '6.983', 'spread': '2.7284', 'groupId': 'OG000'}, {'value': '6.979', 'spread': '2.5706', 'groupId': 'OG001'}, {'value': '7.013', 'spread': '2.7490', 'groupId': 'OG002'}, {'value': '6.917', 'spread': '2.6312', 'groupId': 'OG003'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '6.323', 'spread': '2.7807', 'groupId': 'OG000'}, {'value': '6.203', 'spread': '2.8719', 'groupId': 'OG001'}, {'value': '6.315', 'spread': '2.7980', 'groupId': 'OG002'}, {'value': '6.039', 'spread': '2.7838', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '5.528', 'spread': '2.9747', 'groupId': 'OG000'}, {'value': '5.538', 'spread': '2.7449', 'groupId': 'OG001'}, {'value': '5.576', 'spread': '2.8508', 'groupId': 'OG002'}, {'value': '5.126', 'spread': '2.7096', 'groupId': 'OG003'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '4.766', 'spread': '2.8631', 'groupId': 'OG000'}, {'value': '4.750', 'spread': '2.6755', 'groupId': 'OG001'}, {'value': '4.891', 'spread': '2.7598', 'groupId': 'OG002'}, {'value': '4.387', 'spread': '2.6004', 'groupId': 'OG003'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '4.204', 'spread': '2.8149', 'groupId': 'OG000'}, {'value': '4.322', 'spread': '2.7254', 'groupId': 'OG001'}, {'value': '4.445', 'spread': '2.7381', 'groupId': 'OG002'}, {'value': '3.839', 'spread': '2.5924', 'groupId': 'OG003'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '3.634', 'spread': '2.6815', 'groupId': 'OG000'}, {'value': '3.763', 'spread': '2.6391', 'groupId': 'OG001'}, {'value': '3.845', 'spread': '2.6634', 'groupId': 'OG002'}, {'value': '3.404', 'spread': '2.6805', 'groupId': 'OG003'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '3.051', 'spread': '2.5229', 'groupId': 'OG000'}, {'value': '3.284', 'spread': '2.6658', 'groupId': 'OG001'}, {'value': '3.256', 'spread': '2.5716', 'groupId': 'OG002'}, {'value': '2.843', 'spread': '2.6469', 'groupId': 'OG003'}]}]}, {'title': 'Day 12', 'categories': [{'measurements': [{'value': '2.609', 'spread': '2.5200', 'groupId': 'OG000'}, {'value': '2.754', 'spread': '2.5680', 'groupId': 'OG001'}, {'value': '2.756', 'spread': '2.3795', 'groupId': 'OG002'}, {'value': '2.413', 'spread': '2.5608', 'groupId': 'OG003'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '2.038', 'spread': '2.4202', 'groupId': 'OG000'}, {'value': '2.246', 'spread': '2.5296', 'groupId': 'OG001'}, {'value': '2.218', 'spread': '2.4293', 'groupId': 'OG002'}, {'value': '1.943', 'spread': '2.4174', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '1.583', 'spread': '2.3289', 'groupId': 'OG000'}, {'value': '1.941', 'spread': '2.5375', 'groupId': 'OG001'}, {'value': '1.836', 'spread': '2.3300', 'groupId': 'OG002'}, {'value': '1.596', 'spread': '2.3637', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '1.332', 'spread': '2.1485', 'groupId': 'OG000'}, {'value': '1.614', 'spread': '2.4459', 'groupId': 'OG001'}, {'value': '1.634', 'spread': '2.3178', 'groupId': 'OG002'}, {'value': '1.352', 'spread': '2.1882', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.\n\nMean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'title': 'Day 1 (Baseline)', 'categories': [{'measurements': [{'value': '9.657', 'spread': '1.1201', 'groupId': 'OG000'}, {'value': '9.628', 'spread': '1.0595', 'groupId': 'OG001'}, {'value': '9.698', 'spread': '1.0319', 'groupId': 'OG002'}, {'value': '9.676', 'spread': '1.0823', 'groupId': 'OG003'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '9.080', 'spread': '2.0160', 'groupId': 'OG000'}, {'value': '8.935', 'spread': '2.0268', 'groupId': 'OG001'}, {'value': '9.127', 'spread': '2.0089', 'groupId': 'OG002'}, {'value': '9.068', 'spread': '2.0278', 'groupId': 'OG003'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '8.545', 'spread': '2.2890', 'groupId': 'OG000'}, {'value': '8.395', 'spread': '2.2583', 'groupId': 'OG001'}, {'value': '8.528', 'spread': '2.2591', 'groupId': 'OG002'}, {'value': '8.594', 'spread': '2.1921', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '7.803', 'spread': '2.4779', 'groupId': 'OG000'}, {'value': '7.577', 'spread': '2.5472', 'groupId': 'OG001'}, {'value': '7.816', 'spread': '2.5849', 'groupId': 'OG002'}, {'value': '7.739', 'spread': '2.5750', 'groupId': 'OG003'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '6.962', 'spread': '2.7401', 'groupId': 'OG000'}, {'value': '6.874', 'spread': '2.5865', 'groupId': 'OG001'}, {'value': '7.061', 'spread': '2.6522', 'groupId': 'OG002'}, {'value': '6.821', 'spread': '2.6717', 'groupId': 'OG003'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '6.315', 'spread': '2.7914', 'groupId': 'OG000'}, {'value': '6.093', 'spread': '2.8809', 'groupId': 'OG001'}, {'value': '6.349', 'spread': '2.7000', 'groupId': 'OG002'}, {'value': '5.937', 'spread': '2.8354', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '5.479', 'spread': '2.9550', 'groupId': 'OG000'}, {'value': '5.400', 'spread': '2.7151', 'groupId': 'OG001'}, {'value': '5.604', 'spread': '2.7800', 'groupId': 'OG002'}, {'value': '4.981', 'spread': '2.7163', 'groupId': 'OG003'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '4.685', 'spread': '2.8250', 'groupId': 'OG000'}, {'value': '4.605', 'spread': '2.6399', 'groupId': 'OG001'}, {'value': '4.892', 'spread': '2.7421', 'groupId': 'OG002'}, {'value': '4.237', 'spread': '2.5914', 'groupId': 'OG003'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '4.117', 'spread': '2.7558', 'groupId': 'OG000'}, {'value': '4.181', 'spread': '2.6773', 'groupId': 'OG001'}, {'value': '4.382', 'spread': '2.6734', 'groupId': 'OG002'}, {'value': '3.652', 'spread': '2.5495', 'groupId': 'OG003'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '3.521', 'spread': '2.6127', 'groupId': 'OG000'}, {'value': '3.628', 'spread': '2.5174', 'groupId': 'OG001'}, {'value': '3.741', 'spread': '2.5507', 'groupId': 'OG002'}, {'value': '3.222', 'spread': '2.6197', 'groupId': 'OG003'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '2.934', 'spread': '2.4039', 'groupId': 'OG000'}, {'value': '3.144', 'spread': '2.5214', 'groupId': 'OG001'}, {'value': '3.146', 'spread': '2.4538', 'groupId': 'OG002'}, {'value': '2.705', 'spread': '2.6042', 'groupId': 'OG003'}]}]}, {'title': 'Day 12', 'categories': [{'measurements': [{'value': '2.493', 'spread': '2.3485', 'groupId': 'OG000'}, {'value': '2.572', 'spread': '2.3785', 'groupId': 'OG001'}, {'value': '2.608', 'spread': '2.2228', 'groupId': 'OG002'}, {'value': '2.300', 'spread': '2.4902', 'groupId': 'OG003'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '1.897', 'spread': '2.2146', 'groupId': 'OG000'}, {'value': '2.065', 'spread': '2.2949', 'groupId': 'OG001'}, {'value': '2.085', 'spread': '2.2013', 'groupId': 'OG002'}, {'value': '1.816', 'spread': '2.3077', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '1.432', 'spread': '2.0812', 'groupId': 'OG000'}, {'value': '1.749', 'spread': '2.2779', 'groupId': 'OG001'}, {'value': '1.708', 'spread': '2.1128', 'groupId': 'OG002'}, {'value': '1.444', 'spread': '2.2198', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '1.221', 'spread': '1.9530', 'groupId': 'OG000'}, {'value': '1.409', 'spread': '2.1312', 'groupId': 'OG001'}, {'value': '1.524', 'spread': '2.0846', 'groupId': 'OG002'}, {'value': '1.193', 'spread': '1.9636', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.\n\nMean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'title': 'Day 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.8', 'spread': '16.89', 'groupId': 'OG000'}, {'value': '36.3', 'spread': '15.82', 'groupId': 'OG001'}, {'value': '36.7', 'spread': '16.21', 'groupId': 'OG002'}, {'value': '36.3', 'spread': '17.00', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.6', 'spread': '15.01', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '13.14', 'groupId': 'OG001'}, {'value': '22.3', 'spread': '13.95', 'groupId': 'OG002'}, {'value': '21.1', 'spread': '13.56', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '10.80', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '11.15', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '10.07', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '10.28', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 7 and Day 14', 'description': 'SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'title': 'Day 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '188', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.7', 'spread': '16.64', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '15.89', 'groupId': 'OG001'}, {'value': '36.4', 'spread': '15.86', 'groupId': 'OG002'}, {'value': '36.2', 'spread': '16.88', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '190', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.3', 'spread': '14.92', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '13.32', 'groupId': 'OG001'}, {'value': '22.2', 'spread': '14.27', 'groupId': 'OG002'}, {'value': '21.0', 'spread': '13.78', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '193', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '10.49', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '11.43', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '9.67', 'groupId': 'OG002'}, {'value': '6.6', 'spread': '10.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 7 and Day 14', 'description': 'SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-35.8', 'spread': '33.25', 'groupId': 'OG000'}, {'value': '-38.2', 'spread': '37.48', 'groupId': 'OG001'}, {'value': '-36.7', 'spread': '34.61', 'groupId': 'OG002'}, {'value': '-39.6', 'spread': '30.42', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-79.3', 'spread': '31.27', 'groupId': 'OG000'}, {'value': '-78.9', 'spread': '31.11', 'groupId': 'OG001'}, {'value': '-78.6', 'spread': '30.53', 'groupId': 'OG002'}, {'value': '-81.5', 'spread': '26.54', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 7 and Day 14', 'description': 'SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}, {'value': '188', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-36.4', 'spread': '32.64', 'groupId': 'OG000'}, {'value': '-39.5', 'spread': '36.68', 'groupId': 'OG001'}, {'value': '-36.7', 'spread': '33.44', 'groupId': 'OG002'}, {'value': '-39.6', 'spread': '30.60', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}, {'value': '188', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-79.8', 'spread': '30.90', 'groupId': 'OG000'}, {'value': '-78.6', 'spread': '31.77', 'groupId': 'OG001'}, {'value': '-79.1', 'spread': '30.16', 'groupId': 'OG002'}, {'value': '-81.0', 'spread': '27.10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 7 and Day 14', 'description': 'SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Responders and Non-responders to Treatment, Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '229', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Responders', 'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}, {'title': 'Non-responders', 'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '227', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Responders', 'measurements': [{'value': '209', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}, {'title': 'Non-responders', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}, {'value': '225', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Responders', 'measurements': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}, {'value': '219', 'groupId': 'OG003'}]}, {'title': 'Non-responders', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '228', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Responders', 'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}, {'value': '224', 'groupId': 'OG003'}]}, {'title': 'Non-responders', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 4, 7, 10 and 15', 'description': 'Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Responders and Non-responders to Treatment, Per-Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'OG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}], 'classes': [{'title': 'Day 4', 'categories': [{'title': 'Responders', 'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}, {'title': 'Non-responders', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'categories': [{'title': 'Responders', 'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}]}, {'title': 'Non-responders', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Day 10', 'categories': [{'title': 'Responders', 'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}]}, {'title': 'Non-responders', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'categories': [{'title': 'Responders', 'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}, {'title': 'Non-responders', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 4, 7, 10 and 15', 'description': 'Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'FG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'FG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'FG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '238'}, {'groupId': 'FG002', 'numSubjects': '238'}, {'groupId': 'FG003', 'numSubjects': '233'}]}, {'type': 'Full Analysis Set', 'comment': 'all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '236'}, {'groupId': 'FG002', 'numSubjects': '238'}, {'groupId': 'FG003', 'numSubjects': '230'}]}, {'type': 'Per-protocol Set', 'comment': 'all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '215'}, {'groupId': 'FG002', 'numSubjects': '212'}, {'groupId': 'FG003', 'numSubjects': '207'}]}, {'type': 'Safety Set', 'comment': 'all randomized patients who received at least one dose of the trial medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '238'}, {'groupId': 'FG002', 'numSubjects': '238'}, {'groupId': 'FG003', 'numSubjects': '233'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '231'}, {'groupId': 'FG002', 'numSubjects': '235'}, {'groupId': 'FG003', 'numSubjects': '225'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Exclusion criteria met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Contact to subject lost', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'screening failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 42 clinical centers located in Bulgaria, Germany, Moldova and Russia.', 'preAssignmentDetails': 'Participants were randomized in 1:1:1:1 ratio'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}, {'value': '944', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: 600 mg Acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'BG001', 'title': 'Group B: 1200 mg Acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'BG002', 'title': 'Group C: 2400 mg Acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)'}, {'id': 'BG003', 'title': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '40.7', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '41.3', 'spread': '13.1', 'groupId': 'BG002'}, {'value': '41.1', 'spread': '14.0', 'groupId': 'BG003'}, {'value': '41.0', 'spread': '13.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '556', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '388', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Caucasian', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}, {'value': '928', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-14', 'size': 1334621, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-20T06:51', 'hasProtocol': True}, {'date': '2020-10-07', 'size': 1480761, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-20T06:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 944}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2019-10-09', 'resultsFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-20', 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.\n\nMean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.'}, {'measure': 'Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.\n\nMean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.'}], 'secondaryOutcomes': [{'measure': 'Time to Onset of Action, Full Analysis Set', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value\\<0.05) improvement from placebo.'}, {'measure': 'Time to Onset of Action, Per-Protocol Set', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value\\<0.05) improvement from placebo.'}, {'measure': 'Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.\n\nMean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.'}, {'measure': 'Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set', 'timeFrame': 'Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.\n\nMean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.'}, {'measure': 'Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set', 'timeFrame': 'Baseline (Day 1), Day 7 and Day 14', 'description': 'SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL.'}, {'measure': 'Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set', 'timeFrame': 'Baseline (Day 1), Day 7 and Day 14', 'description': 'SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL.'}, {'measure': 'Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set', 'timeFrame': 'Baseline (Day 1), Day 7 and Day 14', 'description': 'SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome.'}, {'measure': 'Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set', 'timeFrame': 'Baseline (Day 1), Day 7 and Day 14', 'description': 'SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome.'}, {'measure': 'Number of Responders and Non-responders to Treatment, Full Analysis Set', 'timeFrame': 'Day 4, 7, 10 and 15', 'description': 'Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported.'}, {'measure': 'Number of Responders and Non-responders to Treatment, Per-Protocol Set', 'timeFrame': 'Day 4, 7, 10 and 15', 'description': 'Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute uncomplicated rhinosinusitis, acetylcysteine'], 'conditions': ['Rhinosinusitis']}, 'descriptionModule': {'briefSummary': 'The trial was conducted as a prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients.', 'detailedDescription': 'The study was the prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients.\n\nPatients underwent screening examinations at Visit 1. Patients who met all inclusion/ no exclusion criteria were randomized at the baseline visit (Day 1) to the double-blind treatment for a duration of 14 days but in case of delayed final visit (Day 15) the patient could voluntarily take reserve study medication for a maximum of 3 additional days.\n\nAfter the end of the double-blind treatment phase, the patients underwent an end-of-treatment (EOT) examinations on Day 15 (+3).\n\nA follow-up phone call within 7 days after Day 15 (or earlier in case of premature termination) was performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female subjects aged between 14 and 75 years inclusive on the date of consent\n2. Diagnosis of acute, uncomplicated rhinosinusitis defined at screening visit 1 and at Visit 2 as:\n\n 1. major symptom score (MSS) assessed by the patient ≥8 and ≤12 points for the following: rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure, whereupon the nasal congestion is mandatory and no more than 3 of the 5 symptoms are rated as severe\n 2. individual score for facial pain/pressure ≥1 (mild) and ≤2 (moderate)\n 3. presence of symptoms ≤3 days prior to screening visit\n3. For adults (≥18 years): Informed consent to participate in the trial provided in written form; For adolescents (≥14 - \\<18 years): own subject informed consent/ assent to participate in the trial and the informed consent from all parent(s)/ legal guardian(s) provided in written form.\n\nExclusion Criteria:\n\n1. History of hypersensitivity or intolerance to the active substance or any of the excipients of the trial medication\n2. Patient with history of hereditary fructose intolerance, galactose intolerance, lactase deficiency or glucose-galactose malabsorption\n3. Chronic rhinosinusitis (symptoms lasting longer than 3 months)\n4. Subjects who have undergone sinus or nasal surgery for chronic rhinosinusitis in the 6 months prior to screening visit\n5. Sinus lavage within 7 days prior to screening visit\n6. Odontogenic rhinosinusitis\n7. Allergic (perennial or seasonal) rhinitis\n8. Bronchial asthma or chronic obstructive pulmonary disease\n9. Nasal polyposis or clinically relevant nasal septum deviation\n10. Concomitant otitis\n11. Intranasal or systemic use of corticosteroids within 30 days prior to screening visit\n12. Intranasal or systemic use of antibiotics within 30 days prior to screening visit\n13. Use of nasal decongestants within 2 days prior to screening visit\n14. Concomitant treatment of common cold-like symptoms within 7 days prior to screening visit with any of the following:\n\n 1. Analgesics\n 2. Non-steroidal anti-inflammatory drugs\n 3. Antihistamines\n15. Concomitant use of intranasal saline irrigation\n16. Use of immunosuppressive agents within 30 days prior to screening visit\n17. Immunocompromised state\n18. Suspicion for acute bacterial rhinosinusitis (defined as presence of purulence for 3 to 4 days with fever ≥ 38.3°C)\n19. Pregnant or breast-feeding female patient\n20. Female patient of childbearing potential (not surgically sterilized/hysterectomized or postmenopausal for at least 1 year) who is not currently using (documented at screening visit) and not willing to use medically reliable methods of contraception for the entire trial duration such as oral, injectable or implantable contraceptives, intrauterine contraceptive devices (IUD), sexual abstinence or vasectomized partner\n21. Any other condition of the patient (e.g. serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardize patient's safety, compliance or adherence to protocol requirements\n22. Participation in ANY research study involving another investigational medicinal product (IMP) within 30 days prior to screening visit, or simultaneous participation in another clinical study or previous participation in present study\n23. Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20 cigarettes daily)\n24. Use of snuff tobacco\n25. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial\n26. Subjects who are known or suspected:\n\n * not to comply with the trial directives\n * not to be reliable or trustworthy\n * to be a dependent person, e.g. a relative, family member, or member/employee of the investigator's or sponsor's staff\n * subject is in custody or submitted to an institution due to a judicial order."}, 'identificationModule': {'nctId': 'NCT04123405', 'briefTitle': 'Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis: a Prospective, Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '2018-08-EFT-1'}, 'secondaryIdInfos': [{'id': '2019-000060-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: 600 mg acetylcysteine', 'description': 'one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)', 'interventionNames': ['Drug: acetylcysteine', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: 1200 mg acetylcysteine', 'description': 'two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)', 'interventionNames': ['Drug: acetylcysteine', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group C: 2400 mg acetylcysteine', 'description': 'four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)', 'interventionNames': ['Drug: acetylcysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group D: Placebo', 'description': 'four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'acetylcysteine', 'type': 'DRUG', 'description': '600 mg tablet', 'armGroupLabels': ['Group A: 600 mg acetylcysteine', 'Group B: 1200 mg acetylcysteine', 'Group C: 2400 mg acetylcysteine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to acetylcysteine', 'armGroupLabels': ['Group A: 600 mg acetylcysteine', 'Group B: 1200 mg acetylcysteine', 'Group D: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Burgas', 'country': 'Bulgaria', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 42.50651, 'lon': 27.46886}}, {'zip': '5300', 'city': 'Gabrovo', 'country': 'Bulgaria', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 42.87419, 'lon': 25.31823}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '8800', 'city': 'Sliven', 'country': 'Bulgaria', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 42.68607, 'lon': 26.32558}}, {'zip': '1000', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1408', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1527', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '8600', 'city': 'Yambol', 'country': 'Bulgaria', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 42.48243, 'lon': 26.50006}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '01139', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '47051', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '2012', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '2025', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '2032', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '2044', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '2051', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '37', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '3005', 'city': 'Orhei', 'country': 'Moldova', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 47.38503, 'lon': 28.82535}}, {'zip': '420029', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '650066', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '117552', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119571', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123184', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '142190', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '630051', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '191025', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '191186', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '192283', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '195197', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196084', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196158', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197376', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '214031', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '150000', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}], 'overallOfficials': [{'name': 'Sandoz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sandoz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}