Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT06065735
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2023-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Concentration-QT Study of Paroxetine in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48', 'description': 'Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants Who Received Paroxetine 20 mg', 'description': 'Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 23, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Participants Who Received Paroxetine 40 mg', 'description': 'Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 19, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Participants Who Received Paroxetine 60 mg', 'description': 'Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 9, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Parosmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Taste disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Catheter site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Euphoric mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Dissociation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Emotional poverty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Sexual dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Yawning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Urinary hesitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}], 'seriousEvents': [{'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received Paroxetine 20 mg', 'description': 'Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.'}, {'id': 'OG001', 'title': 'Participants Who Received Paroxetine 40 mg', 'description': 'Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.'}, {'id': 'OG002', 'title': 'Participants Who Received Paroxetine 60 mg', 'description': 'Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.'}], 'classes': [{'title': '0.25 Hours Pre-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '7.37', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '10.82', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '9.88', 'groupId': 'OG002'}]}]}, {'title': '1 Hour Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '10.68', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '12.60', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '13.35', 'groupId': 'OG002'}]}]}, {'title': '2 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '10.83', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '11.05', 'groupId': 'OG002'}]}]}, {'title': '3 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.1', 'spread': '8.48', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '10.10', 'groupId': 'OG001'}, {'value': '-6.9', 'spread': '8.92', 'groupId': 'OG002'}]}]}, {'title': '4 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '9.68', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '10.48', 'groupId': 'OG001'}, {'value': '-4.6', 'spread': '10.70', 'groupId': 'OG002'}]}]}, {'title': '4.5 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '8.26', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '11.85', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '11.15', 'groupId': 'OG002'}]}]}, {'title': '5 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '10.08', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '12.53', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '10.37', 'groupId': 'OG002'}]}]}, {'title': '5.5 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '8.49', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '11.91', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '10.57', 'groupId': 'OG002'}]}]}, {'title': '6 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '11.35', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '8.51', 'groupId': 'OG002'}]}]}, {'title': '8 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '12.34', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '13.35', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '11.76', 'groupId': 'OG002'}]}]}, {'title': '10 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '9.62', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '10.22', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': '12.51', 'groupId': 'OG002'}]}]}, {'title': '12 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '10.41', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '10.61', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '12.06', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 0.25 Hours Pre-dose on Day 1; 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12 Hours Post-dose on Day 1', 'description': 'A standard 12-lead electrocardiogram (ECG) were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value.', 'unitOfMeasure': 'Milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic Population included all participants in the Safety Population who had at least 1 non-missing ECG assessment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants Receiving Paroxetine', 'description': 'Participants received paroxetine tablets titrated to a dose of 60 mg once daily at increments of 20 mg per week. Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7 followed by paroxetine 40 mg tablets, orally once daily from Days 8 to 14 and then paroxetine 60 mg tablets orally once daily from Days 15 to 21. Participants were followed-up for up-to Day 48.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '6.474', 'spread': '5.8713', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '4.763', 'spread': '5.9340', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 48', 'description': 'SBP and DBP were measured in the supine position using a semi-automatic blood pressure recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and standard deviation (SD) values of vital sign assessments at Day 48 are reported.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least one dose of study intervention. As all participants received 20, 40 and 60 mg of paroxetine and as there was no intent of comparison of vital signs across these doses, the results were planned to be presented as a single overall arm.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Sign: Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants Receiving Paroxetine', 'description': 'Participants received paroxetine tablets titrated to a dose of 60 mg once daily at increments of 20 mg per week. Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7 followed by paroxetine 40 mg tablets, orally once daily from Days 8 to 14 and then paroxetine 60 mg tablets orally once daily from Days 15 to 21. Participants were followed-up for up-to Day 48.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.842', 'spread': '5.0325', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 48', 'description': 'Pulse rate was measured in the supine position using a semi-automatic recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported.', 'unitOfMeasure': 'Beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least one dose of study intervention. As all participants received 20, 40 and 60 mg of paroxetine and as there was no intent of comparison of vital signs across these doses, the results were planned to be presented as a single overall arm.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Sign: Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants Receiving Paroxetine', 'description': 'Participants received paroxetine tablets titrated to a dose of 60 mg once daily at increments of 20 mg per week. Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7 followed by paroxetine 40 mg tablets, orally once daily from Days 8 to 14 and then paroxetine 60 mg tablets orally once daily from Days 15 to 21. Participants were followed-up for up-to Day 48.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.047', 'spread': '0.1109', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 48', 'description': 'Body temperature measurements were performed in participants. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported.', 'unitOfMeasure': 'Degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least one dose of study intervention. As all participants received 20, 40 and 60 mg of paroxetine and as there was no intent of comparison of vital signs across these doses, the results were planned to be presented as a single overall arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received Paroxetine 20 mg', 'description': 'Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.'}, {'id': 'OG001', 'title': 'Participants Who Received Paroxetine 40 mg', 'description': 'Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.'}, {'id': 'OG002', 'title': 'Participants Who Received Paroxetine 60 mg', 'description': 'Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 48', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or any other situation as determined per medical and scientific judgment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received Paroxetine 20 mg', 'description': 'Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.'}, {'id': 'OG001', 'title': 'Participants Who Received Paroxetine 40 mg', 'description': 'Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.'}, {'id': 'OG002', 'title': 'Participants Who Received Paroxetine 60 mg', 'description': 'Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.'}], 'classes': [{'title': 'Hematology', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Clinical chemistry', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Coagulation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 48', 'description': 'The laboratory measurements included hematology, clinical chemistry and coagulation parameters. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets, Reticulocytes, Alanine Aminotransferase, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Potassium, Sodium, Creatinine kinase, Prothrombin time (PT), activated partial thromboplastin time (aPTT), international normalized ration (INR). Clinical significance was determined by the investigator. Number of participants with clinically significant findings in hematology, clinical chemistry and coagulation were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Findings for Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received Paroxetine 20 mg', 'description': 'Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.'}, {'id': 'OG001', 'title': 'Participants Who Received Paroxetine 40 mg', 'description': 'Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.'}, {'id': 'OG002', 'title': 'Participants Who Received Paroxetine 60 mg', 'description': 'Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 48', 'description': 'Vital signs included systolic and diastolic blood pressure, pulse rate and body temperature. Blood pressure and pulse rate were measured with the participant in supine position after at least 5 minutes rest. Clinical significance was determined by the investigator. Number of participants with clinically significant findings in vital signs were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Findings for Physical Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received Paroxetine 20 mg', 'description': 'Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.'}, {'id': 'OG001', 'title': 'Participants Who Received Paroxetine 40 mg', 'description': 'Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.'}, {'id': 'OG002', 'title': 'Participants Who Received Paroxetine 60 mg', 'description': 'Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 48', 'description': 'Physical examinations included assessment of skin, lungs, cardiovascular system, and abdomen (liver and spleen). Clinical significance was determined by the investigator. Number of Participants with clinically significant findings for physical examinations were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least one dose of study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants Who Received Paroxetine 20 mg', 'description': 'Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.'}, {'id': 'FG001', 'title': 'Participants Who Received Paroxetine 40 mg', 'description': 'Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.'}, {'id': 'FG002', 'title': 'Participants Who Received Paroxetine 60 mg', 'description': 'Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.'}], 'periods': [{'title': 'Paroxetine 20 mg (Days 1 to 7)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Paroxetine 40 mg (Days 8 to 14)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants who completed 20 mg arm entered 40 mg arm.', 'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Paroxetine 60 mg (Days 15 to 21)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Participants who completed 40 mg arm entered 60 mg arm.', 'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study investigated the cardiac effects, safety, and tolerability of paroxetine in healthy adult participants.', 'preAssignmentDetails': 'A total of 38 participants were enrolled in the study to receive 20 milligrams (mg), 40 mg and 60 mg doses of paroxetine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants Receiving Paroxetine', 'description': 'Participants received paroxetine tablets titrated to a dose of 60 mg once daily at increments of 20 mg per week. Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7 followed by paroxetine 40 mg tablets, orally once daily from Days 8 to 14 and then paroxetine 60 mg tablets orally once daily from Days 15 to 21. Participants were followed-up for up-to Day 48.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '11.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'De-identified', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Race categories (with 0\\<n\\<11) are combined into one 'De-identified' category to maintain participant confidentiality and privacy, as they could lead to participant re-identification.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-20', 'size': 2997513, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-29T06:13', 'hasProtocol': True}, {'date': '2023-12-07', 'size': 2008547, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-29T06:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2023-09-26', 'resultsFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2023-09-26', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-29', 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)', 'timeFrame': 'Baseline (Day -1); 0.25 Hours Pre-dose on Day 1; 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12 Hours Post-dose on Day 1', 'description': 'A standard 12-lead electrocardiogram (ECG) were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'timeFrame': 'Baseline (Day -1) and Day 48', 'description': 'SBP and DBP were measured in the supine position using a semi-automatic blood pressure recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and standard deviation (SD) values of vital sign assessments at Day 48 are reported.'}, {'measure': 'Change From Baseline in Vital Sign: Pulse Rate', 'timeFrame': 'Baseline (Day -1) and Day 48', 'description': 'Pulse rate was measured in the supine position using a semi-automatic recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported.'}, {'measure': 'Change From Baseline in Vital Sign: Body Temperature', 'timeFrame': 'Baseline (Day -1) and Day 48', 'description': 'Body temperature measurements were performed in participants. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Day 48', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or any other situation as determined per medical and scientific judgment.'}, {'measure': 'Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters', 'timeFrame': 'Up to Day 48', 'description': 'The laboratory measurements included hematology, clinical chemistry and coagulation parameters. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets, Reticulocytes, Alanine Aminotransferase, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Potassium, Sodium, Creatinine kinase, Prothrombin time (PT), activated partial thromboplastin time (aPTT), international normalized ration (INR). Clinical significance was determined by the investigator. Number of participants with clinically significant findings in hematology, clinical chemistry and coagulation were reported.'}, {'measure': 'Number of Participants With Clinically Significant Findings for Vital Signs', 'timeFrame': 'Up to Day 48', 'description': 'Vital signs included systolic and diastolic blood pressure, pulse rate and body temperature. Blood pressure and pulse rate were measured with the participant in supine position after at least 5 minutes rest. Clinical significance was determined by the investigator. Number of participants with clinically significant findings in vital signs were reported.'}, {'measure': 'Number of Participants With Clinically Significant Findings for Physical Examinations', 'timeFrame': 'Up to Day 48', 'description': 'Physical examinations included assessment of skin, lungs, cardiovascular system, and abdomen (liver and spleen). Clinical significance was determined by the investigator. Number of Participants with clinically significant findings for physical examinations were reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dose escalation', 'QTc Interval', 'Paroxetine', 'Healthy Adults'], 'conditions': ['Anxiety Disorders']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to evaluate the potential effect of paroxetine on QTc interval following escalating doses in healthy participants. Participants with no history of cardiac abnormalities or mood disorders will be enrolled. During the study, participants will take paroxetine at three incremental dose levels. Participants will attend the clinic at screening, baseline, at the end of each dose level administration week, and a final study exit visit. While on treatment outside of clinic visits, participants will be followed-up via video-call. A concentration-QTc analysis will assess any potential correlation between paroxetine plasma concentration and QTc prolongation. In addition, the occurrence of any side-effects will be compared between on and off treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants, both male and female, aged between 18 to 65 years, at the time of signing the informed consent.\n* Participants determined as healthy based on medical evaluation by an experienced physician.\n* A female participant is eligible to participate if she is of:\n\n * Nonchildbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.\n * Child-bearing potential and agrees to use one of the contraception methods for an appropriate time as mentioned in the study protocol.\n* Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase, and bilirubin ≤ 1.5x (Upper Limit of Normal) ULN (isolated bilirubin \\>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\<35%).\n* Body weight ≥ 45 kilogram (kg) and Body Mass Index (BMI) within the range 18 to 29.5 kilogram per metre square (kg/m2) (inclusive).\n* No significant abnormality on 12-lead Electrocardiogram (ECG) at Screening in supine position, including the following specific requirements:\n\n 1. Heart rate ≥ 40 beats per minute\n 2. PR interval ≤ 220 milliseconds (msec) (For PR, QRS and QTcF interval, and Q wave, the mean of triplicate ECGs will be used)\n 3. Q waves \\< 50 msec (For PR, QRS and QTcF interval, and Q wave, the mean of triplicate ECGs will be used)\n 4. QRS interval to be ≥ 60msec and \\< 120msec (For PR, QRS and QTcF interval, and Q wave, the mean of triplicate ECGs will be used)\n 5. The waveforms must enable the QT interval to be clearly defined\n 6. QTcF interval must be \\< 450msec (machine or manual reading).\n* A signed and dated written informed consent obtained from participants capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n* Non-smokers (never smoked or not smoking for \\>6 months with \\<10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked) or light smokers (less than 5 cigarettes per day).\n\nExclusion Criteria:\n\n* History or presence of any medically significant disease that may cause additional risk or interfere with the study procedures or outcome.\n* History of symptomatic arrhythmias.\n* History of hypersensitivity to paroxetine and excipients\n* History of abnormal coagulation parameters, bleeding disorders or conditions which may predispose to bleeding.\n* History of, or active suicidal ideation. Includes assessment using the Columbia Suicide Severity Rating Scale (C-SSRS)\n* Must not have a pre-diagnosed mood disorder\n* Participant is mentally or legally incapacitated.\n* A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHG) at Screening.\n* A supine heart rate outside the range 50-90 beats per minute (bpm) at Screening.\n* A positive screening Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).\n* A positive drug/alcohol screen at screening or prior to dosing.\n* A positive test for Human Immune Virus (HIV) antibody at Screening.\n* History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of \\>21 units for males or \\>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\\~240 millilitre \\[ml\\]) of beer, 1 glass (125ml) of wine or 1 (25 ml) measure of spirits.\n* The participant has participated in a clinical trial and has received an investigational product within the following time prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).\n* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.\n* Use of the following medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of the study medication: monoamine oxidase inhibitors (including linezolid), thioridazine, pimozide, serotonergic drugs (including L-tryptophan, triptans, tramadol, selective serotonin reuptake inhibitors, lithium and fentanyl, tamoxifen, anti-coagulants, clozapine, phenothiazines, tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs, Cox-2 inhibitors, antiarrhythmics, quinolone antibiotics, macrolides (including clarithromycin and erythromycin), ketoconazole and itraconazole\n* Use of non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.\n* No current use of any medication other than paracetamol (doses ≤2 grams/day).\n* Consumption of Seville oranges, pummelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication.\n* Where participation in the study would result in donation of blood or blood products more than 500 mL within a 3-month period.\n* Pregnant females as determined by positive serum β-HCG test at screening or serum/ urine beta-Human chorionic gonadotropin (HCG) prior to dosing.\n* Lactating females.\n* Unwillingness or inability to follow the procedures outlined in the protocol.\n* Participants with unsuitable veins for cannulation and repeat venepuncture."}, 'identificationModule': {'nctId': 'NCT06065735', 'briefTitle': 'Concentration-QT Study of Paroxetine in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-Label, Single Arm, Dose Escalating Concentration-QT Study to Investigate the Cardiac Effects and Safety of Paroxetine in Healthy Adult Participants', 'orgStudyIdInfo': {'id': '219882'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paroxetine', 'interventionNames': ['Drug: Paroxetine']}], 'interventions': [{'name': 'Paroxetine', 'type': 'DRUG', 'description': 'Paroxetine will be administered', 'armGroupLabels': ['Paroxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA1 3UJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://www.gsk.com/en-gb/innovation/trials/data-transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.', 'ipdSharing': 'YES', 'description': "Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/", 'accessCriteria': 'Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}