Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT04799158
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2021-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006356', 'term': 'Heartburn'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552956', 'term': '1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinformation@phathompharma.com', 'phone': '1-888-775-PHAT', 'title': 'Phathom Medical Information', 'phoneExt': '7426', 'organization': 'Phathom Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49', 'description': 'Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period.\n\nOn-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Run-In Period', 'description': 'Participants received oral vonoprazan 20 mg QD for up to 4 weeks.', 'otherNumAtRisk': 457, 'deathsNumAtRisk': 457, 'otherNumAffected': 29, 'seriousNumAtRisk': 457, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 8, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 9, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 8, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 10, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nail avulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Post-traumatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urine analysis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 457, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}, {'units': 'evaluable heartburn episodes', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}, {'value': '370', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG001', 'title': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG002', 'title': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG003', 'title': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}, {'value': '60.6', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}, {'value': '27.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.7', 'ciLowerLimit': '21.84', 'ciUpperLimit': '35.55', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.3', 'ciLowerLimit': '26.28', 'ciUpperLimit': '40.23', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.7', 'ciLowerLimit': '35.92', 'ciUpperLimit': '49.42', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'description': 'An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.\n\nFor a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.', 'unitOfMeasure': 'percentage of heartburn episodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'evaluable heartburn episodes', 'denomUnitsSelected': 'evaluable heartburn episodes', 'populationDescription': 'Intent-to-Treat (ITT) On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours After Taking Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}, {'units': 'evaluable heartburn episodes', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}, {'value': '370', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG001', 'title': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG002', 'title': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG003', 'title': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000'}, {'value': '65.7', 'groupId': 'OG001'}, {'value': '79.6', 'groupId': 'OG002'}, {'value': '41.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.3', 'ciLowerLimit': '23.41', 'ciUpperLimit': '37.09', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.9', 'ciLowerLimit': '16.67', 'ciUpperLimit': '31.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.7', 'ciLowerLimit': '31.00', 'ciUpperLimit': '44.35', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'description': 'An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.\n\nFor a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug.', 'unitOfMeasure': 'percentage of heartburn episodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'evaluable heartburn episodes', 'denomUnitsSelected': 'evaluable heartburn episodes', 'populationDescription': 'ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Evaluable Heartburn Episodes for Each Participant That Are Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG001', 'title': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG002', 'title': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG003', 'title': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.08', 'spread': '38.452', 'groupId': 'OG000'}, {'value': '60.78', 'spread': '37.458', 'groupId': 'OG001'}, {'value': '71.99', 'spread': '28.894', 'groupId': 'OG002'}, {'value': '47.77', 'spread': '40.998', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1771', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1551', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0094', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'description': 'An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.\n\nFor a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.', 'unitOfMeasure': '% of heartburn episodes per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period. Only participants with at least one evaluable heartburn episode during the On-Demand Treatment Period are included.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Tablets of Rescue Antacid Taken Per Day Over the On-Demand Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG001', 'title': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG002', 'title': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG003', 'title': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '0.87', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3395', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4882', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0722', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'unitOfMeasure': 'tablets of rescue antacid per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Relief of Heartburn Within 3 Hours After the First Episode and With No Further Heartburn Reported for 24 Hours After Taking Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG001', 'title': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG002', 'title': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG003', 'title': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000'}, {'value': '61.9', 'groupId': 'OG001'}, {'value': '62.8', 'groupId': 'OG002'}, {'value': '60.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8300', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-24.41', 'ciUpperLimit': '16.52', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-19.28', 'ciUpperLimit': '22.16', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-18.22', 'ciUpperLimit': '22.88', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'description': 'An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.\n\nFor a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period. Only participants with at least one evaluable heartburn episode during the On-Demand Treatment Period are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days Study Drug Was Taken Over the On-Demand Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG001', 'title': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG002', 'title': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG003', 'title': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.93', 'spread': '19.241', 'groupId': 'OG000'}, {'value': '20.75', 'spread': '16.950', 'groupId': 'OG001'}, {'value': '21.01', 'spread': '17.302', 'groupId': 'OG002'}, {'value': '22.15', 'spread': '23.266', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4684', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6560', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6324', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Percentage of 24-Hour Heartburn-Free Days Over the On-Demand Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG001', 'title': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG002', 'title': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}, {'id': 'OG003', 'title': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.95', 'spread': '21.410', 'groupId': 'OG000'}, {'value': '73.57', 'spread': '21.465', 'groupId': 'OG001'}, {'value': '74.01', 'spread': '22.277', 'groupId': 'OG002'}, {'value': '71.22', 'spread': '28.867', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9896', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6916', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9316', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'description': 'A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Run-In Period', 'description': 'Participants received oral vonoprazan 20 mg once daily (QD) for up to 4 weeks.'}, {'id': 'FG001', 'title': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.'}, {'id': 'FG002', 'title': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.'}, {'id': 'FG003', 'title': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.'}, {'id': 'FG004', 'title': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.'}], 'periods': [{'title': 'Run-In Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '458'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Significant Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Did not meet On-Demand Eligibility Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'On-Demand Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'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': '1'}]}, {'type': 'Significant Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was performed at 54 sites in the United States between 25 March 2021 and 17 January 2022. Of the 1115 participants screened for the study, 458 participants were enrolled into the Run-In Period. Of these participants, 207 participants were randomized to receive study drug in the On-Demand treatment period.', 'preAssignmentDetails': 'Eligible participants who had symptomatic NERD were initially dosed during an open-label Run-In Period with vonoprazan 20 mg once per day (QD) for 4 weeks. Participants with stable disease (defined by those who had no heartburn on the last 7 consecutive days of the Run-In Period) and were compliant with the electronic diary and study drug were randomized using a 1:1:1:1 allocation ratio to receive either vonoprazan 10 mg, 20 mg, or 40 mg or placebo during the 6-week On-Demand Treatment Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '193', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.'}, {'id': 'BG001', 'title': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.'}, {'id': 'BG002', 'title': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.'}, {'id': 'BG003', 'title': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '11.89', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '12.87', 'groupId': 'BG001'}, {'value': '52.0', 'spread': '14.60', 'groupId': 'BG002'}, {'value': '52.7', 'spread': '15.20', 'groupId': 'BG003'}, {'value': '53.7', 'spread': '13.65', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '133', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '136', 'groupId': 'BG004'}]}, {'title': 'Black or African-American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'On-Demand Treatment Period: The Safety On-Demand Set included all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-16', 'size': 2079445, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-31T08:38', 'hasProtocol': True}, {'date': '2022-01-25', 'size': 1230675, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-31T08:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'During the Run-In Period, participants will receive open-label vonoprazan.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 458}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-08', 'studyFirstSubmitDate': '2021-03-11', 'resultsFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-08', 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'description': 'An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.\n\nFor a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours After Taking Study Drug', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'description': 'An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.\n\nFor a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug.'}, {'measure': 'Percentage of Evaluable Heartburn Episodes for Each Participant That Are Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'description': 'An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.\n\nFor a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.'}, {'measure': 'Mean Number of Tablets of Rescue Antacid Taken Per Day Over the On-Demand Treatment Period', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42'}, {'measure': 'Percentage of Participants With Complete Relief of Heartburn Within 3 Hours After the First Episode and With No Further Heartburn Reported for 24 Hours After Taking Study Drug', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'description': 'An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.\n\nFor a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.'}, {'measure': 'Percentage of Days Study Drug Was Taken Over the On-Demand Treatment Period', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42'}, {'measure': 'Percentage of 24-Hour Heartburn-Free Days Over the On-Demand Treatment Period', 'timeFrame': 'On-Demand Treatment Period: Day 1 to Day 42', 'description': 'A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Symptomatic Non-Erosive Gastroesophageal Reflux Disease', 'NERD', 'Vonoprazan', 'Heartburn'], 'conditions': ['Non-Erosive Gastro-Esophageal Reflux Disease', 'Heartburn']}, 'referencesModule': {'references': [{'pmid': '37750406', 'type': 'DERIVED', 'citation': 'Fass R, Vaezi M, Sharma P, Yadlapati R, Hunt B, Harris T, Smith N, Leifke E, Armstrong D. Randomised clinical trial: Efficacy and safety of on-demand vonoprazan versus placebo for non-erosive reflux disease. Aliment Pharmacol Ther. 2023 Nov;58(10):1016-1027. doi: 10.1111/apt.17728. Epub 2023 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in participants with symptomatic NERD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for Run-In Period\n\n1. The participant is ≥18 years of age at the time of informed consent signing.\n2. In the opinion of the investigator or sub investigators, the participant is capable of understanding and complying with protocol requirements.\n3. The participant signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.\n4. The participant identified their main symptom as heartburn, a burning sensation in the retrosternal area (behind the breastbone).\n5. History of episodes of heartburn for 6 months or longer prior to screening.\n6. Heartburn reported on 4 or more days during any 7 consecutive days in the Screening Period as recorded in the electronic diary.\n7. A female participant of childbearing potential who is or may be sexually active with a non sterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.\n\nInclusion Criteria for On-Demand Treatment Period\n\n1. The participant completes the Run-In Period, during which the participant was at least 80% compliant with open-label study drug.\n2. The participant has stable disease, ie, no heartburn the last 7 days of the Run-In Period.\n3. The participant continues to fulfill all eligibility criteria for the Run-In Period (except Inclusion Criteria 4).\n4. Participant completes at least 80% of diary entries during Run-In Period, including 80% of diary entries over the last 7 days.\n\nExclusion Criteria for Run-In Period\n\n1. Endoscopically confirmed erosive esophagitis (EE) during the Screening Period assessed by the investigator. Endoscopy should be performed after participants meet Inclusion Criteria 6. Any endoscopic confirmation performed in a routine clinical setting within 7 days before signing the informed consent is acceptable to use for the purpose of fulfilling the screening requirement.\n2. The participant has active irritable bowel syndrome (IBS) or had a flare of IBS requiring therapy within the prior 6 months.\n3. The participant has a history of or is suspected of having functional heartburn diagnosed by the Rome IV criteria.\n4. The participant has a history of or is suspected of having functional dyspepsia diagnosed by the Rome IV criteria.\n5. The participant has endoscopic Barrett's esophagus (\\>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.\n6. The participant has any other clinically significant condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) or hiatal hernia are eligible to participate.\n7. The participant has scleroderma (systemic sclerosis).\n8. The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).\n9. The participant has an active gastric or duodenal ulcer within 4 weeks before the first dose of study drug.\n10. Use of prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) throughout the study.\n11. The participant has received vonoprazan in a clinical trial at any time or any other investigational compound (including those in post-marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.\n12. The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.\n13. The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.\n14. The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to screening.\n15. The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.\n16. The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red or yellow ferric oxide). Skin testing may be performed according to local standard practice to confirm hypersensitivity.\n17. The participant has a history of alcohol abuse, illegal drug use, drug addiction, or regularly consumes \\>21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report within the 12 months prior to screening. Participants must have a negative urine drug screen for cannabinoids/ tetrahydrocannabinol and nonprescribed medications at screening. Participants taking prescription drugs (except prescription cannabinoids/tetrahydrocannabinol) will be allowed.\n18. The participant is taking any excluded medications or treatments listed in the protocol.\n19. If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study, or intending to donate ova during such time period.\n20. The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.\n21. The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.\n22. The participant has a history of malignancy or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has recovered from cutaneous basal cell carcinoma or cervical carcinoma in situ).\n23. The participant has acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection, or tests positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or HCV ribonucleic acid (HCV-RNA). However, participants who test positive for HCV antibody but negative for HCV-RNA are permitted to participate.\n24. The participant has any of the following abnormal laboratory test values at the start of the Screening Period:\n\n 1. Creatinine levels: \\>2 mg/dL (\\>177 μmol/L)\n 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2 × the upper limit of normal (ULN) or total bilirubin \\>2 × ULN (except participants with Gilbert Syndrome)"}, 'identificationModule': {'nctId': 'NCT04799158', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Phathom Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg, 20 mg, and 40 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'NERD-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Run-In Period', 'description': 'Participants will receive vonoprazan 20 mg once daily for up to 4 weeks.', 'interventionNames': ['Drug: Vonoprazan']}, {'type': 'EXPERIMENTAL', 'label': 'Vonoprazan 10 mg: On-Demand Treatment Period', 'description': 'Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 10 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.', 'interventionNames': ['Drug: Vonoprazan']}, {'type': 'EXPERIMENTAL', 'label': 'Vonoprazan 20 mg: On-Demand Treatment Period', 'description': 'Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 20 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.', 'interventionNames': ['Drug: Vonoprazan']}, {'type': 'EXPERIMENTAL', 'label': 'Vonoprazan 40 mg: On-Demand Treatment Period', 'description': 'Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 40 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.', 'interventionNames': ['Drug: Vonoprazan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo: On-Demand Treatment Period', 'description': 'Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take a placebo when heartburn occurs during the 6 week On-Demand Treatment Period. 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'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Phathom Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data from this study will be published; however, it is undecided if patient level data will be made available at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phathom Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}