Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT02730169
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2016-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'enquiries@mereobiopharma.com', 'phone': '+44 (0) 333 023 7300', 'title': 'Jackie Parkin', 'organization': 'Mereo BioPharma Group'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'After randomisation and up to 90 days after the last administration of study drug.', 'description': "The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.", 'eventGroups': [{'id': 'EG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 37, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 39, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 47, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo weekly (3 indistinguishable placebo capsules)\n\nPlacebo: Capsules will be taken weekly for a maximum of 24 weeks', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 41, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Bacterial prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Haematocrit increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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Levels \\>1000 ng/dL were considered super-physiological outside the normal range. This secondary outcome measure was considered to have been met for a dose if ≥ 90% of subjects in the intent-to-treat (ITT) population had normalisation of total testosterone levels at Week 24.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 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'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.503', 'spread': '2.2230', 'groupId': 'OG000'}, {'value': '3.511', 'spread': '3.7050', 'groupId': 'OG001'}, {'value': '5.064', 'spread': '3.9739', 'groupId': 'OG002'}, {'value': '-0.341', 'spread': '1.4575', 'groupId': 'OG003'}]}]}, {'title': 'Visit 6 (Week 16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.557', 'spread': '1.6964', 'groupId': 'OG000'}, {'value': '3.704', 'spread': '3.6269', 'groupId': 'OG001'}, {'value': '5.004', 'spread': '4.3397', 'groupId': 'OG002'}, {'value': '-0.395', 'spread': '1.4793', 'groupId': 'OG003'}]}]}, {'title': 'Visit 7 (Week 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.553', 'spread': '2.2380', 'groupId': 'OG000'}, {'value': '3.653', 'spread': '3.7381', 'groupId': 'OG001'}, {'value': '4.884', 'spread': '3.9297', 'groupId': 'OG002'}, {'value': '-0.193', 'spread': '1.3585', 'groupId': 'OG003'}]}]}, {'title': 'Visit 8 (Week 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.108', 'spread': '1.9892', 'groupId': 'OG000'}, {'value': '3.560', 'spread': '3.6138', 'groupId': 'OG001'}, {'value': '5.209', 'spread': '4.4894', 'groupId': 'OG002'}, {'value': '-0.043', 'spread': '1.5575', 'groupId': 'OG003'}]}]}], 'paramType': 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The Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo weekly (3 indistinguishable placebo capsules)\n\nPlacebo: Capsules will be taken weekly for a maximum of 24 weeks'}], 'classes': [{'title': 'Visit 2 (Day 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.553', 'spread': '2.2022', 'groupId': 'OG000'}, {'value': '4.575', 'spread': '2.0756', 'groupId': 'OG001'}, {'value': '5.307', 'spread': '2.8315', 'groupId': 'OG002'}, {'value': '-0.51', 'spread': '0.8273', 'groupId': 'OG003'}]}]}, {'title': 'Visit 3 (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.158', 'spread': '2.1353', 'groupId': 'OG000'}, {'value': '5.540', 'spread': '2.8344', 'groupId': 'OG001'}, {'value': '6.551', 'spread': '4.2155', 'groupId': 'OG002'}, {'value': '-0.111', 'spread': '1.0638', 'groupId': 'OG003'}]}]}, {'title': 'Visit 4 (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.318', 'spread': '2.4147', 'groupId': 'OG000'}, {'value': '5.878', 'spread': '2.9916', 'groupId': 'OG001'}, {'value': '7.620', 'spread': '4.7883', 'groupId': 'OG002'}, {'value': '0.047', 'spread': '1.2241', 'groupId': 'OG003'}]}]}, {'title': 'Visit 5 (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.809', 'spread': '2.5582', 'groupId': 'OG000'}, {'value': '5.768', 'spread': '3.2474', 'groupId': 'OG001'}, {'value': '8.132', 'spread': '5.9526', 'groupId': 'OG002'}, {'value': '-0.075', 'spread': '1.0723', 'groupId': 'OG003'}]}]}, {'title': 'Visit 6 (Week 16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.188', 'spread': '2.6876', 'groupId': 'OG000'}, {'value': '6.350', 'spread': '3.4261', 'groupId': 'OG001'}, {'value': '8.045', 'spread': '6.1773', 'groupId': 'OG002'}, {'value': '-0.165', 'spread': '1.1924', 'groupId': 'OG003'}]}]}, {'title': 'Visit 7 (Week 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.059', 'spread': '2.5714', 'groupId': 'OG000'}, {'value': '6.073', 'spread': '3.5199', 'groupId': 'OG001'}, {'value': '8.409', 'spread': '6.6502', 'groupId': 'OG002'}, {'value': '-0.030', 'spread': '1.0932', 'groupId': 'OG003'}]}]}, {'title': 'Visit 8 (Week 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.836', 'spread': '2.6901', 'groupId': 'OG000'}, {'value': '6.183', 'spread': '3.4817', 'groupId': 'OG001'}, {'value': '8.282', 'spread': '7.0523', 'groupId': 'OG002'}, {'value': '0.038', 'spread': '1.2164', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks', 'description': 'FSH was measured at baseline, Visit 1 through 8 and follow-up. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}], 'classes': [{'title': 'Visit 5 (Week 12), Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.83'}, {'value': '2.55', 'groupId': 'OG001', 'lowerLimit': '2.33', 'upperLimit': '2.80'}, {'value': '8.93', 'groupId': 'OG002', 'lowerLimit': '8.29', 'upperLimit': '9.62'}]}]}, {'title': 'Visit 5 (Week 12), 1 hour Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.43', 'groupId': 'OG000', 'lowerLimit': '1.24', 'upperLimit': '1.65'}, {'value': '4.39', 'groupId': 'OG001', 'lowerLimit': '3.89', 'upperLimit': '4.97'}, {'value': '14.91', 'groupId': 'OG002', 'lowerLimit': '13.52', 'upperLimit': '16.45'}]}]}, {'title': 'Visit 8 (Week 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '1.00'}, {'value': '2.97', 'groupId': 'OG001', 'lowerLimit': '2.20', 'upperLimit': '4.00'}, {'value': '10.04', 'groupId': 'OG002', 'lowerLimit': '8.23', 'upperLimit': '12.25'}]}]}, {'title': 'Visit 8 (Week 24)/End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.97'}, {'value': '2.76', 'groupId': 'OG001', 'lowerLimit': '2.14', 'upperLimit': '3.57'}, {'value': '9.10', 'groupId': 'OG002', 'lowerLimit': '7.61', 'upperLimit': '10.89'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment', 'description': 'Plasma PK sampling for BGS649 was performed at Weeks 12 and 24. BGS649 PK plasma concentrations were summarised for the PK population by descriptive statistics.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}], 'classes': [{'title': 'Visit 8 (Week 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '0.61'}, {'value': '1.95', 'groupId': 'OG001', 'lowerLimit': '1.60', 'upperLimit': '2.38'}, {'value': '5.81', 'groupId': 'OG002', 'lowerLimit': '4.63', 'upperLimit': '7.28'}]}]}, {'title': 'Visit 8 (Week 24)/End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.58'}, {'value': '1.58', 'groupId': 'OG001', 'lowerLimit': '1.19', 'upperLimit': '2.08'}, {'value': '5.28', 'groupId': 'OG002', 'lowerLimit': '4.16', 'upperLimit': '6.71'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 24 and week 24/End of treatment', 'description': 'Semen PK sampling for BGS649 was performed at Visit 8 (End of Treatment). BGS649 PK semen concentrations were summarised for the PK population by descriptive statistics.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo weekly (3 indistinguishable placebo capsules)\n\nPlacebo: Capsules will be taken weekly for a maximum of 24 weeks'}], 'classes': [{'title': 'Visit 2 (Day 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.045', 'spread': '0.1840', 'groupId': 'OG000'}, {'value': '0.040', 'spread': '0.4830', 'groupId': 'OG001'}, {'value': '0.011', 'spread': '0.4606', 'groupId': 'OG002'}, {'value': '0.015', 'spread': '0.2179', 'groupId': 'OG003'}]}]}, {'title': 'Visit 3 (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.141', 'spread': '0.1742', 'groupId': 'OG000'}, {'value': '0.082', 'spread': '0.5198', 'groupId': 'OG001'}, {'value': '0.092', 'spread': '0.4338', 'groupId': 'OG002'}, {'value': '0.038', 'spread': '0.2700', 'groupId': 'OG003'}]}]}, {'title': 'Visit 4 (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.166', 'spread': '0.2651', 'groupId': 'OG000'}, {'value': '0.105', 'spread': '0.4747', 'groupId': 'OG001'}, {'value': '0.132', 'spread': '0.3343', 'groupId': 'OG002'}, {'value': '0.055', 'spread': '0.4500', 'groupId': 'OG003'}]}]}, {'title': 'Visit 5 (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.190', 'spread': '0.3895', 'groupId': 'OG000'}, {'value': '0.271', 'spread': '0.9626', 'groupId': 'OG001'}, {'value': '0.178', 'spread': '0.5405', 'groupId': 'OG002'}, {'value': '0.039', 'spread': '0.4382', 'groupId': 'OG003'}]}]}, {'title': 'Visit 6 (Week 16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.147', 'spread': '0.2655', 'groupId': 'OG000'}, {'value': '0.102', 'spread': '0.5500', 'groupId': 'OG001'}, {'value': '0.160', 'spread': '0.4037', 'groupId': 'OG002'}, {'value': '0.016', 'spread': '0.2631', 'groupId': 'OG003'}]}]}, {'title': 'Visit 7 (Week 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.158', 'spread': '0.2913', 'groupId': 'OG000'}, {'value': '0.480', 'spread': '2.6029', 'groupId': 'OG001'}, {'value': '0.116', 'spread': '0.4560', 'groupId': 'OG002'}, {'value': '0.022', 'spread': '0.3942', 'groupId': 'OG003'}]}]}, {'title': 'Visit 8 (Week 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.218', 'spread': '0.4312', 'groupId': 'OG000'}, {'value': '0.391', 'spread': '1.8627', 'groupId': 'OG001'}, {'value': '0.085', 'spread': '0.2930', 'groupId': 'OG002'}, {'value': '0.067', 'spread': '0.4787', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks', 'description': 'PSA was measured alongside other clinical chemistry parameters at screening, baseline, Visits 1 through 8 and at follow-up.', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean (SD) Change From Baseline in Haematocrit to Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo weekly (3 indistinguishable placebo capsules)\n\nPlacebo: Capsules will be taken weekly for a maximum of 24 weeks'}], 'classes': [{'title': 'Visit 2 (Day 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.0003', 'spread': '0.02279', 'groupId': 'OG000'}, {'value': '0.0014', 'spread': '0.01945', 'groupId': 'OG001'}, {'value': '-0.0016', 'spread': '0.03487', 'groupId': 'OG002'}, {'value': '-0.0029', 'spread': '0.02374', 'groupId': 'OG003'}]}]}, {'title': 'Visit 3 (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0036', 'spread': '0.01855', 'groupId': 'OG000'}, {'value': '0.0024', 'spread': '0.02095', 'groupId': 'OG001'}, {'value': '0.0067', 'spread': '0.02997', 'groupId': 'OG002'}, {'value': '-0.0024', 'spread': '0.02539', 'groupId': 'OG003'}]}]}, {'title': 'Visit 4 (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0151', 'spread': '0.02153', 'groupId': 'OG000'}, {'value': '0.0162', 'spread': '0.02709', 'groupId': 'OG001'}, {'value': '0.0258', 'spread': '0.03233', 'groupId': 'OG002'}, {'value': '-0.0041', 'spread': '0.02383', 'groupId': 'OG003'}]}]}, {'title': 'Visit 5 (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0153', 'spread': '0.02419', 'groupId': 'OG000'}, {'value': '0.0175', 'spread': '0.02270', 'groupId': 'OG001'}, {'value': '0.0256', 'spread': '0.02906', 'groupId': 'OG002'}, {'value': '-0.0082', 'spread': '0.02882', 'groupId': 'OG003'}]}]}, {'title': 'Visit 6 (Week 16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0142', 'spread': '0.02195', 'groupId': 'OG000'}, {'value': '0.0233', 'spread': '0.02408', 'groupId': 'OG001'}, {'value': '0.0229', 'spread': '0.03260', 'groupId': 'OG002'}, {'value': '-0.0079', 'spread': '0.02533', 'groupId': 'OG003'}]}]}, {'title': 'Visit 7 (Week 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0195', 'spread': '0.02545', 'groupId': 'OG000'}, {'value': '0.0192', 'spread': '0.02672', 'groupId': 'OG001'}, {'value': '0.0187', 'spread': '0.03222', 'groupId': 'OG002'}, {'value': '-0.0063', 'spread': '0.03037', 'groupId': 'OG003'}]}]}, {'title': 'Visit 8 (Week 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0171', 'spread': '0.02612', 'groupId': 'OG000'}, {'value': '0.0159', 'spread': '0.02621', 'groupId': 'OG001'}, {'value': '0.0216', 'spread': '0.02587', 'groupId': 'OG002'}, {'value': '-0.0032', 'spread': '0.02884', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks', 'description': 'Haematocrit was measured alongside other haematology parameters at screening, baseline, Visits 1 through 8 and at follow-up.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo weekly (3 indistinguishable placebo capsules)\n\nPlacebo: Capsules will be taken weekly for a maximum of 24 weeks'}], 'classes': [{'title': 'Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.382', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.315', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.323', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.266', 'groupId': 'OG003'}]}]}, {'title': 'Femoral neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.337', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.441', 'groupId': 'OG001'}, {'value': '-0.11', 'spread': '0.392', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.212', 'groupId': 'OG003'}]}]}, {'title': 'Lumber spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.279', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.381', 'groupId': 'OG001'}, {'value': 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DEXA T-score was calculated based on actual measured bone density value and compared to a standard reference range for healthy young adult men.\n\nA bone density scan compares bone density with the bone density expected for a young healthy adult or a healthy adult of the same age, gender and ethnicity. The difference is calculated as a standard deviation (SD) score. The measures between the bone density and the expected value of a young healthy adult is known as the T score.\n\nThe World Health Organization (WHO) classifies T scores as follows:\n\n* above -1 SD is normal\n* between -1 and -2.5 SD is defined as mildly reduced bone mineral density (BMD) compared with peak bone mass (PBM)\n* at or below -2.5 SD is defined as osteoporosis', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo weekly (3 indistinguishable placebo capsules)\n\nPlacebo: Capsules will be taken weekly for a maximum of 24 weeks'}], 'classes': [{'title': 'Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.0026', 'spread': '0.03990', 'groupId': 'OG000'}, {'value': '-0.0020', 'spread': '0.03828', 'groupId': 'OG001'}, {'value': '-0.0072', 'spread': '0.02724', 'groupId': 'OG002'}, {'value': '0.0005', 'spread': '0.03315', 'groupId': 'OG003'}]}]}, {'title': 'Femoral neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.0248', 'spread': '0.04583', 'groupId': 'OG000'}, {'value': '-0.0044', 'spread': '0.06666', 'groupId': 'OG001'}, {'value': '-0.0116', 'spread': '0.05139', 'groupId': 'OG002'}, {'value': '0.0028', 'spread': '0.02747', 'groupId': 'OG003'}]}]}, {'title': 'Lumber spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.0167', 'spread': '0.03174', 'groupId': 'OG000'}, {'value': '-0.0177', 'spread': '0.05018', 'groupId': 'OG001'}, {'value': '-0.0255', 'spread': '0.04044', 'groupId': 'OG002'}, {'value': '0.0100', 'spread': '0.04016', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening to Week 24', 'description': 'Summary of DEXA scan density at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. Bone density was evaluated with standard procedure for Hologic and General Electric Lunar scanners.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo weekly (3 indistinguishable placebo capsules)\n\nPlacebo: Capsules will be taken weekly for a maximum of 24 weeks'}], 'classes': [{'title': 'Type I Collagen C-Telopeptides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.054', 'spread': '0.1454', 'groupId': 'OG000'}, {'value': '0.069', 'spread': '0.1618', 'groupId': 'OG001'}, {'value': '0.047', 'spread': '0.1342', 'groupId': 'OG002'}, {'value': '0.020', 'spread': '0.2087', 'groupId': 'OG003'}]}]}, {'title': 'Procollagen 1 N-Terminal Propeptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '8.31', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '11.93', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '11.68', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '11.61', 'groupId': 'OG003'}]}]}, {'title': 'Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.72', 'spread': '2.891', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '3.801', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '3.604', 'groupId': 'OG002'}, {'value': '0.30', 'spread': '3.267', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening to Week 24', 'description': 'Descriptive statistics were presented for the following bone turnover marker parameters: type I collagen C-telopeptides, procollagen 1 N-terminal propeptide, osteocalcin, and bone specific alkaline phosphatase.', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Discrepancies in numbers from the progress flow are due to missing samples either at baseline or wk 24/EOT.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'OG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will 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'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event of Special Interest', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '271', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'BGS649 0.1 mg', 'description': 'BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'BG001', 'title': 'BGS649 0.3 mg', 'description': 'BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'BG002', 'title': 'BGS649 1.0 mg', 'description': 'BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)\n\nBGS649: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo weekly (3 indistinguishable placebo capsules)\n\nPlacebo: Capsules will be taken weekly for a maximum of 24 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'spread': '8.39', 'groupId': 'BG000'}, {'value': '51.6', 'spread': '7.31', 'groupId': 'BG001'}, {'value': '49.6', 'spread': '9.72', 'groupId': 'BG002'}, {'value': '50.9', 'spread': '9.17', 'groupId': 'BG003'}, {'value': '50.8', 'spread': '8.69', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '271', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race as defined by the NIH/OMB guidelines', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-10', 'size': 1204525, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-08T10:11', 'hasProtocol': True}, {'date': '2018-06-07', 'size': 1614043, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-08T10:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2018-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-26', 'studyFirstSubmitDate': '2016-03-17', 'resultsFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-03', 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24.', 'timeFrame': 'Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks', 'description': 'PSA was measured alongside other clinical chemistry parameters at screening, baseline, Visits 1 through 8 and at follow-up.'}, {'measure': 'Mean (SD) Change From Baseline in Haematocrit to Week 24.', 'timeFrame': 'Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks', 'description': 'Haematocrit was measured alongside other haematology parameters at screening, baseline, Visits 1 through 8 and at follow-up.'}, {'measure': 'Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24.', 'timeFrame': 'Screening to Week 24', 'description': 'Summary of DEXA Scan T-score at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. DEXA T-score was calculated based on actual measured bone density value and compared to a standard reference range for healthy young adult men.\n\nA bone density scan compares bone density with the bone density expected for a young healthy adult or a healthy adult of the same age, gender and ethnicity. The difference is calculated as a standard deviation (SD) score. The measures between the bone density and the expected value of a young healthy adult is known as the T score.\n\nThe World Health Organization (WHO) classifies T scores as follows:\n\n* above -1 SD is normal\n* between -1 and -2.5 SD is defined as mildly reduced bone mineral density (BMD) compared with peak bone mass (PBM)\n* at or below -2.5 SD is defined as osteoporosis'}, {'measure': 'Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24', 'timeFrame': 'Screening to Week 24', 'description': 'Summary of DEXA scan density at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. Bone density was evaluated with standard procedure for Hologic and General Electric Lunar scanners.'}, {'measure': 'Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24.', 'timeFrame': 'Screening to Week 24', 'description': 'Descriptive statistics were presented for the following bone turnover marker parameters: type I collagen C-telopeptides, procollagen 1 N-terminal propeptide, osteocalcin, and bone specific alkaline phosphatase.'}, {'measure': 'Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24.', 'timeFrame': '24 weeks', 'description': 'Change from baseline in bone specific alkaline phosphatase at week 24 measured in U/L'}], 'primaryOutcomes': [{'measure': 'Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment', 'timeFrame': '24 weeks of treatment', 'description': 'Percentage of patients with normalised testosterone i.e. testosterone in the range 300-1000ng/dL after 24 weeks of study treatment. The primary objective was considered met, if greater than or equal to 75% of the participants in any arm normalised.'}], 'secondaryOutcomes': [{'measure': 'The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24', 'timeFrame': 'Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks', 'description': 'Normalised total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels \\>1000 ng/dL were considered super-physiological outside the normal range.'}, {'measure': 'Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24', 'timeFrame': 'Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks', 'description': 'Testosterone overshoot was defined as total testosterone above 1000 ng/dL (35 nmol/L). Samples were collected in the morning before 11 am pre dose.'}, {'measure': 'Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment.', 'timeFrame': '24 weeks of treatment', 'description': 'Normalized total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels \\>1000 ng/dL were considered super-physiological outside the normal range. This secondary outcome measure was considered to have been met for a dose if ≥ 90% of subjects in the intent-to-treat (ITT) population had normalisation of total testosterone levels at Week 24.'}, {'measure': 'Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.', 'timeFrame': 'Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks', 'description': 'LH was measured at screening, baseline. The Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.'}, {'measure': 'Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24.', 'timeFrame': 'Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks', 'description': 'FSH was measured at baseline, Visit 1 through 8 and follow-up. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.'}, {'measure': 'Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks.', 'timeFrame': 'Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment', 'description': 'Plasma PK sampling for BGS649 was performed at Weeks 12 and 24. BGS649 PK plasma concentrations were summarised for the PK population by descriptive statistics.'}, {'measure': 'Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks.', 'timeFrame': 'Week 24 and week 24/End of treatment', 'description': 'Semen PK sampling for BGS649 was performed at Visit 8 (End of Treatment). BGS649 PK semen concentrations were summarised for the PK population by descriptive statistics.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypogonadotropic', 'hypogonadism', 'testosterone'], 'conditions': ['Hypogonadotropic Hypogonadism']}, 'referencesModule': {'references': [{'pmid': '37579053', 'type': 'DERIVED', 'citation': 'Jones TH, Dobs AS, Randeva H, Moore W, Parkin JM. Leflutrozole in male obesity-associated hypogonadotropic hypogonadism: Ph 2b double-blind randomised controlled trial. Eur J Endocrinol. 2023 Sep 1;189(3):297-308. doi: 10.1093/ejendo/lvad099.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male subject aged 18 to 65 years inclusive\n* BMI \\> 30 kg/m2 and \\< 50 kg/m2\n* Serum total testosterone concentration below the normal range\n* LH levels below the upper limit of normal\n* Oestradiol levels within or above the normal range of approved assay\n* At least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunction\n\nExclusion Criteria:\n\n* Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments\n* Other types of hypogonadotropic hypogonadism or primary hypogonadism\n* Any other pituitary or hypothalamic disease'}, 'identificationModule': {'nctId': 'NCT02730169', 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