Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT02250651
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2014-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'Portugal', 'Saudi Arabia', 'Thailand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009339', 'term': 'Needles'}, {'id': 'D013999', 'term': 'Timolol'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug to last visit (Up to approximately 20 months)', 'description': 'All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \\[fellow-eye\\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.', 'eventGroups': [{'id': 'EG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'otherNumAtRisk': 176, 'deathsNumAtRisk': 176, 'otherNumAffected': 133, 'seriousNumAtRisk': 176, 'deathsNumAffected': 1, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'otherNumAtRisk': 175, 'deathsNumAtRisk': 176, 'otherNumAffected': 103, 'seriousNumAtRisk': 175, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 176, 'otherNumAffected': 72, 'seriousNumAtRisk': 173, 'deathsNumAffected': 1, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Conjunctival hyperaemia', 'notes': '138 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=71, Bimatoprost SR 10 ug=48, and Timolol 0.5%=19); 86 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 20}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal endothelial cell loss', 'notes': '50 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=38, Bimatoprost SR 10 ug=11, and Timolol 0.5%=1); 4 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Eye pain', 'notes': '40 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=21, Bimatoprost SR 10 ug=11, and Timolol 0.5%=8); 16 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal oedema', 'notes': '26 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=21, Bimatoprost SR 10 ug=5).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Foreign body sensation in eyes', 'notes': '37 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=18, Bimatoprost SR 10 ug=17, and Timolol 0.5%=2); 17 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dry eye', 'notes': '33 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=16, Bimatoprost SR 10 ug=10, and Timolol 0.5%=7); 31 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Conjunctival haemorrhage', 'notes': '42 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=14, Bimatoprost SR 10 ug=16, and Timolol 0.5%=12); 22 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Punctate keratitis', 'notes': '28 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=13, Bimatoprost SR 10 ug=8, and Timolol 0.5%=7); 26 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Photophobia', 'notes': '26 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=13, Bimatoprost SR 10 ug=13); 13 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Eye irritation', 'notes': '28 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=12, Bimatoprost SR 10 ug=9, and Timolol 0.5%=7); 23 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anterior chamber cell', 'notes': '19 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=12, Bimatoprost SR 10 ug=6, and Timolol 0.5%=1); 1 adverse event occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ocular discomfort', 'notes': '15 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=11, Bimatoprost SR 10 ug=3, and Timolol 0.5%=1); 4 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Iritis', 'notes': '17 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=9, Bimatoprost SR 10 ug=8); 1 adverse event occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lacrimation increased', 'notes': '16 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=9, Bimatoprost SR 10 ug=6, and Timolol 0.5%=1); 12 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vision blurred', 'notes': '17 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=7, Bimatoprost SR 10 ug=9, and Timolol 0.5%=1); 11 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blepharitis', 'notes': '21 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=7, Bimatoprost SR 10 ug=9, and Timolol 0.5%=5); 18 adverse events occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Prostate cancer', 'notes': 'Number of participants at risk are male participants as this adverse event is specific to males.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Breast cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Natural killer-cell leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': "Waldenstrom's macroglobulinaemia", 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Oropharyngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Follicular thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Small intestine carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Menorrhagia', 'notes': 'Number of participants at risk are female participants as this adverse event is specific to females.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ovarian cyst', 'notes': 'Number of participants at risk are female participants as this adverse event is specific to females.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Penetrating aortic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal endothelial cell loss', 'notes': '12 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=9, Bimatoprost SR 10 ug=3).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal oedema', 'notes': '3 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=2, Bimatoprost SR 10 ug=1).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Macular oedema', 'notes': '1 adverse event occurred in the study eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Product administered at inappropriate site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pterygium', 'notes': '1 adverse event occurred in the study eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'VIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal decompensation', 'notes': '1 adverse event occurred in the study eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Retinal detachment', 'notes': '1 adverse event occurred in the study eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Visual impairment', 'notes': '1 adverse event occurred in the study eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Retinal tear', 'notes': '1 adverse event occurred in the fellow (non-study) eye.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'title': 'Change from Baseline at Week 12, Hour 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.47', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-6.18', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-6.11', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12, Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.16', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-6.72', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-6.36', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3738', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.8514', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0401', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.3621', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT Population, all randomized participants, with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 2 (Hour 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.74', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '16.92', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '17.50', 'spread': '0.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0382', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.1133', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 2 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT Population, all randomized participants, with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 2 (Hour 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.09', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '16.48', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '17.19', 'spread': '0.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '-0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0364', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '-0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 2 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT Population, all randomized participants, with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 6 (Hour 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.05', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '16.93', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '17.51', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2304', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'groupDescription': 'Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.1272', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'groupDescription': 'Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT Population, all randomized participants, with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 6 (Hour 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.13', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '16.53', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '17.18', 'spread': '0.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0741', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.36', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT Population, all randomized participants, with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 12 (Hour 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.39', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '17.68', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '17.75', 'spread': '0.30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3738', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.8514', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT Population, all randomized participants, with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 12 (Hour 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.70', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '17.15', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '17.50', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0401', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.3621', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT Population, all randomized participants, with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IOP in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'title': 'Change from Baseline at Week 2, Hour 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.12', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-6.94', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '-6.36', 'spread': '0.27', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 2, Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.77', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-7.38', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '-6.67', 'spread': '0.25', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 6, Hour 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.81', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-6.93', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-6.35', 'spread': '0.29', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 6, Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.74', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-7.33', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-6.69', 'spread': '0.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0382', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.1133', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '-0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0364', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '-0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.2304', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'groupDescription': 'Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.1272', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'groupDescription': 'Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0038', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0741', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.36', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT Population, all randomized participants, with data available for analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'FG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'FG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'periods': [{'title': 'Treatment Period 1 (Day 1 to Week 15)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '176'}]}, {'type': 'Received Sham or Bimatoprost SR', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '173'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '170'}, {'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Randomized but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}, {'title': 'Treatment Period 2 (Week 16 to Week 31)', 'milestones': [{'type': 'STARTED', 'comment': 'Started=received administration (Sham or Bimatoprost SR) in the cycle', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '168'}, {'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3 (Week 32 to Week 52)', 'milestones': [{'type': 'STARTED', 'comment': 'Started=received administration (Sham or Bimatoprost SR) in the cycle', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '152'}, {'groupId': 'FG002', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '528', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'BG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'BG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '528', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '63.8', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '62.5', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '12.4', 'groupId': 'BG002'}, {'value': '62.6', 'spread': '12.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '528', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '259', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '528', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '335', 'groupId': 'BG003'}]}, {'title': 'Black or African and American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Hispanic', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intraocular Pressure (IOP)', 'classes': [{'title': 'Hour 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '527', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24.39', 'groupId': 'BG000', 'lowerLimit': '18.0', 'upperLimit': '32.0'}, {'value': '24.28', 'groupId': 'BG001', 'lowerLimit': '15.0', 'upperLimit': '32.0'}, {'value': '24.46', 'groupId': 'BG002', 'lowerLimit': '17.0', 'upperLimit': '32.0'}, {'value': '24.38', 'groupId': 'BG003', 'lowerLimit': '15.0', 'upperLimit': '32.0'}]}]}, {'title': 'Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '526', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23.41', 'groupId': 'BG000', 'lowerLimit': '18.5', 'upperLimit': '32.0'}, {'value': '23.24', 'groupId': 'BG001', 'lowerLimit': '14.0', 'upperLimit': '32.0'}, {'value': '23.43', 'groupId': 'BG002', 'lowerLimit': '15.0', 'upperLimit': '32.0'}, {'value': '23.36', 'groupId': 'BG003', 'lowerLimit': '14.0', 'upperLimit': '32.0'}]}]}], 'paramType': 'MEAN', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'The number analyzed is the number of participants with data available for IOP at Baseline.'}], 'populationDescription': 'Intent-to-treat (ITT) Population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-05', 'size': 1756912, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-29T15:38', 'hasProtocol': True}, {'date': '2018-10-29', 'size': 538984, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-29T15:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 528}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2019-08-20', 'completionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2014-09-23', 'dispFirstSubmitQcDate': '2019-08-20', 'resultsFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2014-09-25', 'dispFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-06', 'studyFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)', 'timeFrame': 'Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.'}, {'measure': 'IOP in the Study Eye at Week 2 (Hour 0)', 'timeFrame': 'Week 2 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}, {'measure': 'IOP in the Study Eye at Week 2 (Hour 2)', 'timeFrame': 'Week 2 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}, {'measure': 'IOP in the Study Eye at Week 6 (Hour 0)', 'timeFrame': 'Week 6 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}, {'measure': 'IOP in the Study Eye at Week 6 (Hour 2)', 'timeFrame': 'Week 6 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}, {'measure': 'IOP in the Study Eye at Week 12 (Hour 0)', 'timeFrame': 'Week 12 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}, {'measure': 'IOP in the Study Eye at Week 12 (Hour 2)', 'timeFrame': 'Week 12 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in IOP in the Study Eye', 'timeFrame': 'Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma, Open-Angle', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '36378864', 'type': 'DERIVED', 'citation': 'Weinreb RN, Bacharach J, Brubaker JW, Medeiros FA, Bejanian M, Bernstein P, Robinson MR. Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):55-62. doi: 10.1089/jop.2022.0137. Epub 2022 Nov 15.'}, {'pmid': '35643967', 'type': 'DERIVED', 'citation': 'Medeiros FA, Sheybani A, Shah MM, Rivas M, Bai Z, Werts E, Ahmed IIK, Craven ER. Single Administration of Intracameral Bimatoprost Implant 10 microg in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.'}, {'pmid': '34724172', 'type': 'DERIVED', 'citation': 'Bacharach J, Tatham A, Ferguson G, Belalcazar S, Thieme H, Goodkin ML, Chen MY, Guo Q, Liu J, Robinson MR, Bejanian M, Wirta DL; ARTEMIS 2 Study Group. Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2). Drugs. 2021 Nov;81(17):2017-2033. doi: 10.1007/s40265-021-01624-9. Epub 2021 Nov 1.'}], 'seeAlsoLinks': [{'url': 'http://www.allerganclinicaltrials.com', 'label': 'More Information'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.\n\nExclusion Criteria:\n\n* Previous enrollment in another Allergan Bimatoprost SR Study\n* Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye\n* Anticipated need for laser eye surgery within the first 52 weeks of the study duration\n* History of glaucoma surgery'}, 'identificationModule': {'nctId': 'NCT02250651', 'briefTitle': 'Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': '192024-092'}, 'secondaryIdInfos': [{'id': '2014-003186-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'interventionNames': ['Drug: Bimatoprost SR', 'Other: Sham: Applicator Without Needle', 'Drug: Active Comparator: Timolol 0.5%', 'Drug: Timolol Vehicle (placebo)']}, {'type': 'EXPERIMENTAL', 'label': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'interventionNames': ['Drug: Bimatoprost SR', 'Other: Sham: Applicator Without Needle', 'Drug: Active Comparator: Timolol 0.5%', 'Drug: Timolol Vehicle (placebo)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol 0.5%: Comparator', 'description': 'Both Eyes: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'interventionNames': ['Other: Sham: Applicator Without Needle', 'Drug: Active Comparator: Timolol 0.5%']}], 'interventions': [{'name': 'Bimatoprost SR', 'type': 'DRUG', 'description': 'Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.', 'armGroupLabels': ['Bimatoprost SR 10 μg', 'Bimatoprost SR 15 μg']}, {'name': 'Sham: Applicator Without Needle', 'type': 'OTHER', 'description': 'Sham administered on Day 1, Week 16, and Week 32.', 'armGroupLabels': ['Bimatoprost SR 10 μg', 'Bimatoprost SR 15 μg', 'Timolol 0.5%: Comparator']}, {'name': 'Active Comparator: Timolol 0.5%', 'type': 'DRUG', 'description': 'Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'armGroupLabels': ['Bimatoprost SR 10 μg', 'Bimatoprost SR 15 μg', 'Timolol 0.5%: Comparator']}, {'name': 'Timolol Vehicle (placebo)', 'type': 'DRUG', 'description': 'Timolol vehicle administered once in the morning and once in the evening for up to 20 months.', 'armGroupLabels': ['Bimatoprost SR 10 μg', 'Bimatoprost SR 15 μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Eye Center South', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Eye Center', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vold Vision', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '91741', 'city': 'Glendora', 'state': 'California', 'country': 'United States', 'facility': 'Mark B. Kislinger, MD, Inc.', 'geoPoint': {'lat': 34.13612, 'lon': -117.86534}}, {'zip': '92545', 'city': 'Hemet', 'state': 'California', 'country': 'United States', 'facility': 'Inland Eye Specialists', 'geoPoint': {'lat': 33.74761, 'lon': -116.97307}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Eye Physicians and Surgeons', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'North Bay Eye Associates, Inc.', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '96002', 'city': 'Redding', 'state': 'California', 'country': 'United States', 'facility': 'Shasta Eye Medical Group, Inc.', 'geoPoint': {'lat': 40.58654, 'lon': -122.39168}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California (UCSF) Department of Ophthalmology', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '93401', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Eye Surgeons', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Shepard Eye Center', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'East West Eye Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Wolstan & Goldberg Eye Associates', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80134', 'city': 'Parker', 'state': 'Colorado', 'country': 'United States', 'facility': 'Insight Vision Group', 'geoPoint': {'lat': 39.5186, 'lon': -104.76136}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Danbury Eye Physicians and Surgeons PC', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '33904', 'city': 'Cape Coral', 'state': 'Florida', 'country': 'United States', 'facility': 'Argus Research at Cape Coral Eye Center', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}, {'zip': '33067', 'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Specialty Retinal Center', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Bruce A Segal, M.D.', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Associates of Fort Myers', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Clinic at Shands Medical Plaza', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33418', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute, University of Miami', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Sight', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33143-3693', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'MedEye Associates', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Eye Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '61201', 'city': 'Rock Island', 'state': 'Illinois', 'country': 'United States', 'facility': 'Virdi Eye Clinic', 'geoPoint': {'lat': 41.50948, 'lon': -90.57875}}, {'zip': '40215', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine, Wilmer Eye Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01890', 'city': 'Winchester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Eye Research of Boston, Co.', 'geoPoint': {'lat': 42.45232, 'lon': -71.137}}, {'zip': '63128', 'city': 'St Louis', 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