Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-26 @ 11:14 AM
Study NCT ID:
NCT02663908
Status:
TERMINATED
Last Update Posted:
2022-06-29
First Post:
2016-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C431566', 'term': 'acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide'}, {'id': 'D016729', 'term': 'Leuprolide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Global Clinical Compliance', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'A Publications Committee, including the signatory investigators, other Steering Committee members, and Sponsor representatives was established to function as an independent body of scientific and medical experts acting to facilitate, encourage, and coordinate the complete and accurate presentation and publication of the trial results. Members of the Publication Committee are responsible for review and approval of all abstracts and manuscripts based on the trial results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The trial was terminated prematurely due to a slower than anticipated recruitment rate and a lower than anticipated observed CV event rate. Approximately 900 patients were planned to be included, however, at the time of stopping screening and recruitment 216 patients had completed the trial, 292 were ongoing, and 37 were withdrawn. The Sponsor decision to stop the trial was not based on any safety concerns, any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.'}}, 'adverseEventsModule': {'timeFrame': 'Start of IMP treatment until 3 months after last dosing of IMP', 'description': "Adverse events were recorded from signing of the informed consent until end-of-trial. Events with onset after start of IMP treatment, and within 3 months after (1 month=28 days) last dosing of IMP, were considered 'treatment-emergent' and are presented for the safety analysis set (defined above). Non-fatal serious adverse events (SAEs) of myocardial infarction, stroke, and unstable angina constituted exceptions to the SAE reporting (6 events in the degarelix group, 10 in the leuprolide group).", 'eventGroups': [{'id': 'EG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.', 'otherNumAtRisk': 275, 'deathsNumAtRisk': 275, 'otherNumAffected': 250, 'seriousNumAtRisk': 275, 'deathsNumAffected': 11, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.', 'otherNumAtRisk': 269, 'deathsNumAtRisk': 269, 'otherNumAffected': 228, 'seriousNumAtRisk': 269, 'deathsNumAffected': 9, 'seriousNumAffected': 44}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 57, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 35, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 232, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 163, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 62, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 79, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 112, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 127, 'numAffected': 120}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 27, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 31, 'numAffected': 23}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'seriousEvents': [{'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diverticulitis intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Enterococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Anastomotic ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and 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'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 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'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hepatic echinococciasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5294', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.283', 'ciLowerLimit': '0.589', 'ciUpperLimit': '2.794', 'estimateComment': 'Baseline hazards for the Cox regression were stratified over variables: age group and region.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Composite MACE endpoint was defined as: death due to any cause, non-fatal myocardial infarction or non-fatal stroke.\n\nKaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) occurrence of composite MACE over time. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to the First Confirmed (Adjudicated) Occurrence of Cardiovascular (CV)-Related Death, Non-fatal Myocardial Infarction or Non-fatal Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7126', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.204', 'ciLowerLimit': '0.448', 'ciUpperLimit': '3.234', 'estimateComment': 'Baseline hazards for the Cox regression were stratified over variables: age group and region.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) occurrence of CV-related death, non-fatal myocardial infarction or non-fatal stroke. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to Confirmed (Adjudicated) CV-related Death; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0853', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.186', 'ciLowerLimit': '0.022', 'ciUpperLimit': '1.595', 'estimateComment': 'Baseline hazards for the Cox regression were stratified over variables: age group and region.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) CV-related death. Percentage of observed subjects with outcome measure events during the trial are reported. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to the First Confirmed (Adjudicated) Myocardial Infarction; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.594', 'ciLowerLimit': '0.381', 'ciUpperLimit': '6.673', 'estimateComment': 'Baseline hazards for the Cox regression were stratified over variables: age group and region.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) myocardial infarction. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to the First Confirmed (Adjudicated) Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8966', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.899', 'ciLowerLimit': '0.181', 'ciUpperLimit': '4.457', 'estimateComment': 'Baseline hazards for the Cox regression were stratified over variables: age group and region.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) stroke. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to the First Confirmed (Adjudicated) Unstable Angina Requiring Hospitalization; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3857', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.480', 'ciLowerLimit': '0.088', 'ciUpperLimit': '2.620', 'estimateComment': 'Baseline hazards for the Cox regression were stratified over variables: age group and region.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) unstable angina requiring hospitalization. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to Death Due to Any Cause; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7180', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.839', 'ciLowerLimit': '0.324', 'ciUpperLimit': '2.176', 'estimateComment': 'Baseline hazards for the Cox regression were stratified over variables: age group and region.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict death due to any cause. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.'}, {'type': 'SECONDARY', 'title': 'Testosterone Levels at Days 28, 168 and 336 in the Degarelix and Leuprolide Treatment Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.650', 'groupId': 'OG000', 'lowerLimit': '6.810', 'upperLimit': '13.960'}, {'value': '14.410', 'groupId': 'OG001', 'lowerLimit': '10.910', 'upperLimit': '20.170'}]}]}, {'title': 'Day 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.650', 'groupId': 'OG000', 'lowerLimit': '5.760', 'upperLimit': '12.750'}, {'value': '8.475', 'groupId': 'OG001', 'lowerLimit': '5.760', 'upperLimit': '11.530'}]}]}, {'title': 'Day 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.855', 'groupId': 'OG000', 'lowerLimit': '5.760', 'upperLimit': '14.410'}, {'value': '8.650', 'groupId': 'OG001', 'lowerLimit': '5.760', 'upperLimit': '11.530'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 28, 168 and 336 (end-of-trial)', 'description': 'Median levels and interquartile ranges for serum testosterone at Days 28, 168, and 336 are presented.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6701', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.887', 'ciLowerLimit': '0.512', 'ciUpperLimit': '1.539', 'estimateComment': 'Baseline hazards for the Cox regression were stratified over variables: age group and region.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to end-of-trial for each subject (subjects not censored at Day 336)', 'description': 'Time to failure in PFS was defined as the time, measured in days, from randomization to the first occurrence of either death, radiographic disease progression, introduction of additional prostate cancer therapies for progression, or PSA failure.\n\nSubjects who discontinued treatment with IMP or withdrew from the trial were censored at the time of discontinuation/withdrawal.\n\nKaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict failure in PFS. Percentage of observed subjects with outcome measure events during the trial are reported.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in International Prostate Symptom Score (IPSS) Total and Quality of Life (QoL) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'title': 'IPSS Total at Day 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.000', 'groupId': 'OG000', 'lowerLimit': '-0.804', 'upperLimit': '0.804'}, {'value': '0.907', 'groupId': 'OG001', 'lowerLimit': '0.098', 'upperLimit': '1.715'}]}]}, {'title': 'IPSS, QoL at Day 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.115', 'groupId': 'OG000', 'lowerLimit': '-0.298', 'upperLimit': '0.068'}, {'value': '0.098', 'groupId': 'OG001', 'lowerLimit': '-0.086', 'upperLimit': '0.282'}]}]}, {'title': 'IPSS Total at Day 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.795', 'groupId': 'OG000', 'lowerLimit': '-1.619', 'upperLimit': '0.029'}, {'value': '0.121', 'groupId': 'OG001', 'lowerLimit': '-0.712', 'upperLimit': '0.953'}]}]}, {'title': 'IPSS, QoL at Day 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.281', 'groupId': 'OG000', 'lowerLimit': '-0.467', 'upperLimit': '-0.095'}, {'value': '-0.234', 'groupId': 'OG001', 'lowerLimit': '-0.422', 'upperLimit': '-0.046'}]}]}], 'analyses': [{'pValue': '0.1193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.907', 'ciLowerLimit': '-2.048', 'ciUpperLimit': '0.235', 'groupDescription': 'IPSS Total at Day 168', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.1080', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.213', 'ciLowerLimit': '-0.473', 'ciUpperLimit': '0.047', 'groupDescription': 'IPSS, QoL at Day 168', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.1256', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.916', 'ciLowerLimit': '-2.089', 'ciUpperLimit': '0.257', 'groupDescription': 'IPSS Total at Day 336', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.7261', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.047', 'ciLowerLimit': '-0.312', 'ciUpperLimit': '0.218', 'groupDescription': 'IPSS, QoL at Day 336', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Days 168 and 336 (end-of-trial)', 'description': "Lower urinary tract symptoms were measured with the IPSS Version 1 (IPSS-1). The IPSS is a subject-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question was assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS-1 score was then calculated as summation over the responses for all 7 questions. The total IPSS-1 score was transformed to a scale from 0 (lowest score) to 100 (highest score). Higher scores reflect higher severity of symptoms. The IPSS-1 included an additional single question to assess a subject's QoL in relation to his urinary symptoms; response to this question was analyzed separately and was not included in the total IPSS score. The score was similarly scaled from 0 to 100.\n\nChange from baseline in IPSS Total and QoL scores are presented.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Total Number of CV-related Hospitalization Events Over the Duration of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of IMP to Day 336 (end-of-trial)', 'description': 'The total number of CV-related hospitalizations over the duration of the trial was defined as the number of hospitalizations due to CV-related adverse events, observed from the first exposure to IMP up until Day 336 for each subject.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Coronary Artery By-pass Grafting (CABG) or Percutaneous Coronary Intervention (PCI) Procedures Over the Duration of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of IMP to Day 336 (end-of-trial)', 'description': 'The total number of CABG or PCI procedures observed for each subject over the duration of the trial', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of CV-related Emergency Room (ER) Visit Events Over the Duration of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of IMP to Day 336 (end-of-trial)', 'description': 'CV-related ER visit events (that did not lead to hospitalization) was observed from the first exposure to IMP up until Day 336 for each subject.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Utility, Based on EuroQol Group 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.794', 'groupId': 'OG000', 'lowerLimit': '0.770', 'upperLimit': '0.818'}, {'value': '0.796', 'groupId': 'OG001', 'lowerLimit': '0.772', 'upperLimit': '0.820'}]}]}], 'analyses': [{'pValue': '0.9110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.002', 'ciLowerLimit': '-0.036', 'ciUpperLimit': '0.032', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Compared using an ANCOVA model, where the QALY is the dependent variable and adjusted for treatment group, age group and region, respectively.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Day 336 (end-of-trial)', 'description': 'The EQ-5D-5L essentially consists of 2 systems - the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS is an overall estimation of the present health status. The results from the EQ-5D-5L questionnaire were converted into quality adjusted life year (QALY) units.\n\nThe QALY is estimated by combining the value of life (utility value) and length of life. Quality adjusted life years are based on a principle assuming that a year of life lived in perfect health is worth 1 QALY and that a year of life lived in a state of less than perfect health is worth less than 1.', 'unitOfMeasure': 'QALY', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Duke Activity Status Index (DASI) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'title': 'Change in DASI to Day 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.65', 'groupId': 'OG000', 'lowerLimit': '-3.95', 'upperLimit': '-1.35'}, {'value': '-1.08', 'groupId': 'OG001', 'lowerLimit': '-2.38', 'upperLimit': '0.23'}]}]}, {'title': 'Change in DASI to Day 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.18', 'groupId': 'OG000', 'lowerLimit': '-3.54', 'upperLimit': '-0.81'}, {'value': '-3.01', 'groupId': 'OG001', 'lowerLimit': '-4.39', 'upperLimit': '-1.63'}]}]}], 'analyses': [{'pValue': '0.0936', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.57', 'ciLowerLimit': '-3.41', 'ciUpperLimit': '0.27', 'groupDescription': 'DASI at Day 168', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.4000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '2.78', 'groupDescription': 'DASI at Day 336', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Days 168 and 336 (end-of-trial)', 'description': "The DASI is a self-administered instrument developed to measure functional capacity in subjects with cardiovascular disease (CVD). It contains 12 items referring to the present time, assessing the ability to perform physical tasks in five domains: personal care (1 item), ambulation (4 items), household tasks (4 items), sexual function (1 item) and recreation (2 items). Each question was answered by one of four options: 'yes with no difficulty' / 'yes, but with some difficulty' / 'no, I can't do this' / 'don't do this for other reasons'. A global score was calculated with a higher score indicating a higher functional capacity. The minimum score is 0 and the maximum score is 58.2 points.\n\nChange from baseline in DASI Global score is presented.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Cardiac Anxiety Questionnaire (CAQ) Global Score and Score Per Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'title': 'CAQ global score (Day 168)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000', 'lowerLimit': '-0.021', 'upperLimit': '0.088'}, {'value': '-0.011', 'groupId': 'OG001', 'lowerLimit': '-0.066', 'upperLimit': '0.044'}]}]}, {'title': 'CAQ domain score for Attention (Day 168)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.030', 'groupId': 'OG000', 'lowerLimit': '-0.034', 'upperLimit': '0.094'}, {'value': '-0.006', 'groupId': 'OG001', 'lowerLimit': '-0.070', 'upperLimit': '0.059'}]}]}, {'title': 'CAQ domain score for Avoidance (Day 168)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.155', 'groupId': 'OG000', 'lowerLimit': '0.062', 'upperLimit': '0.248'}, {'value': '0.039', 'groupId': 'OG001', 'lowerLimit': '-0.054', 'upperLimit': '0.133'}]}]}, {'title': 'CAQ domain score for Fear (Day 168)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.036', 'groupId': 'OG000', 'lowerLimit': '-0.106', 'upperLimit': '0.034'}, {'value': '-0.048', 'groupId': 'OG001', 'lowerLimit': '-0.119', 'upperLimit': '0.022'}]}]}, {'title': 'CAQ global score (Day 336)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.102', 'groupId': 'OG000', 'lowerLimit': '0.043', 'upperLimit': '0.161'}, {'value': '0.051', 'groupId': 'OG001', 'lowerLimit': '-0.009', 'upperLimit': '0.110'}]}]}, {'title': 'CAQ domain score for Attention (Day 336)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000', 'lowerLimit': '-0.046', 'upperLimit': '0.092'}, {'value': '-0.015', 'groupId': 'OG001', 'lowerLimit': '-0.085', 'upperLimit': '0.054'}]}]}, {'title': 'CAQ domain score for Avoidance (Day 336)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.228', 'groupId': 'OG000', 'lowerLimit': '0.130', 'upperLimit': '0.325'}, {'value': '0.220', 'groupId': 'OG001', 'lowerLimit': '0.122', 'upperLimit': '0.319'}]}]}, {'title': 'CAQ domain score for Fear (Day 336)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.075', 'groupId': 'OG000', 'lowerLimit': '-0.003', 'upperLimit': '0.153'}, {'value': '-0.018', 'groupId': 'OG001', 'lowerLimit': '-0.097', 'upperLimit': '0.061'}]}]}], 'analyses': [{'pValue': '0.2535', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.045', 'ciLowerLimit': '-0.032', 'ciUpperLimit': '0.122', 'groupDescription': 'CAQ Global Score at Day 168', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.4370', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.036', 'ciLowerLimit': '-0.055', 'ciUpperLimit': '0.127', 'groupDescription': 'CAQ domain score for Attention at Day 168', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.0852', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.116', 'ciLowerLimit': '-0.016', 'ciUpperLimit': '0.248', 'groupDescription': 'CAQ domain score for Avoidance at Day 168', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.8156', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.012', 'ciLowerLimit': '-0.087', 'ciUpperLimit': '0.111', 'groupDescription': 'CAQ domain score for Fear at Day 168', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.2299', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.051', 'ciLowerLimit': '-0.033', 'ciUpperLimit': '0.135', 'groupDescription': 'CAQ Global Score at Day 336', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.4440', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.038', 'ciLowerLimit': '-0.060', 'ciUpperLimit': '0.136', 'groupDescription': 'CAQ domain score for Attention at Day 336', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.9172', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.007', 'ciLowerLimit': '-0.131', 'ciUpperLimit': '0.146', 'groupDescription': 'CAQ domain score for Avoidance at Day 336', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}, {'pValue': '0.1028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.093', 'ciLowerLimit': '-0.019', 'ciUpperLimit': '0.204', 'groupDescription': 'CAQ domain score for Fear at Day 336', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Days 168 and 336 (end-of-trial)', 'description': 'The CAQ is a self-administered questionnaire developed to measure heart-focused anxiety in persons with or without heart disease. It contains 18 items referring to the present time assessing cardiac anxiety in three domains: fear (8 items, each item could be scored between 0 "never" to 4 "always", maximum total score 32), avoidance (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20) and attention (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20). A higher score indicated greater cardiac anxiety and the total score range was between 0 and 72.\n\nChange from baseline in CAQ Global score and score per domain are presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'AE leading to death', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Start of IMP treatment until 3 months after last dosing of IMP', 'description': "Adverse events were recorded from signed informed consent until end-of-trial. Adverse events with onset after start of IMP treatment, and within 3 months after (1 month=28 days) last dosing of IMP, were considered 'treatment-emergent' and are presented for the safety analysis set.", 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all treated subjects (who received at least one dose of IMP) and was analyzed based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Intensity of AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'title': 'Mild AE', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}]}, {'title': 'Moderate AE', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Severe AE', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Start of IMP treatment until 3 months after last dosing of IMP', 'description': 'The intensity of AE was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.02) 5-point scale.\n\nAE were categorized as grade 1 Mild (minor; no specific medical intervention; asymptomatic laboratory findings only; marginal clinical relevance), Grade 2 Moderate (minimal intervention: local intervention; non-invasive intervention), Grade 3 Severe (significant symptoms, requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation), Grade 4 Life-threatening or disabling (complicated by acute, life-threatening metabolic or CV complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation) and Grade 5 Death. Events with grades 3, 4 and 5 were categorized as severe.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all treated subjects (who received at least one dose of IMP) and was analyzed based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Changes in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'OG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 336 (end-of-trial)', 'description': 'Number of subjects shifting from normal value(s) in vital signs (pulse and blood pressure) at baseline to clinically significant abnormal value(s) at end-of-trial are presented.\n\nNote: Only subjects with appropriate baseline and post-baseline data are included in the evaluation.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all treated subjects (who received at least one dose of IMP) and was analyzed based on the actual treatment received. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two subcutaneous (SC) depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'FG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '269'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '269'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '245'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COVID-19', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject to begin treatment with an exclusionary medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject ended trial due to being prescribed prohibited medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Intolerance to FIRMAGON therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject randomized in error and did not receive the IMP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject discontinued treatment as he was in hospice and could not make it for end-of-trial visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was performed at 113 investigational sites in 12 countries between Apr 2016 to Mar 2021.', 'preAssignmentDetails': 'In total, 702 subjects were screened of which 545 subjects were randomized. Of the randomized subjects, 544 subjects were exposed to the investigational medicinal product (IMP): 275 to Degarelix and 269 to Leuprolide. One subject was randomized in error and not exposed to IMP.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.'}, {'id': 'BG001', 'title': 'Leuprolide 22.5 mg', 'description': 'Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '73.3', 'spread': '7.28', 'groupId': 'BG000'}, {'value': '73.1', 'spread': '7.16', 'groupId': 'BG001'}, {'value': '73.2', 'spread': '7.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}]}, {'title': '>= 75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Finland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline body mass index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.38', 'spread': '5.057', 'groupId': 'BG000'}, {'value': '28.58', 'spread': '4.589', 'groupId': 'BG001'}, {'value': '28.48', 'spread': '4.828', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed differs from the overall population as baseline BMI was not reported for some of the subjects.'}, {'title': 'Stage of prostate cancer', 'classes': [{'title': 'Localized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}]}, {'title': 'Locally Advanced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}, {'title': 'Metastatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}, {'title': 'Not classifiable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) performance score', 'classes': [{'title': '0 score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}]}, {'title': '1 score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}, {'title': '2 score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The ECOG performance status was assessed according to a scale from 0 to 4, where 0 is fully active, able to carry on all pre-disease performance without restriction and where 4 is completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Testosterone levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '543', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '353.6', 'spread': '150.49', 'groupId': 'BG000'}, {'value': '351.6', 'spread': '140.32', 'groupId': 'BG001'}, {'value': '352.6', 'spread': '145.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed differs from the overall population as baseline testosterone was not reported for some of the subjects.'}, {'title': 'Prostate Specific Antigen (PSA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '543', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '119.7', 'spread': '472.10', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '236.68', 'groupId': 'BG001'}, {'value': '90.2', 'spread': '375.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed differs from the overall population as baseline PSA was not reported for some of the subjects.'}], 'populationDescription': 'The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-26', 'size': 1198607, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-21T05:01', 'hasProtocol': True}, {'date': '2021-02-24', 'size': 718716, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-21T05:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 545}}, 'statusModule': {'whyStopped': 'Recruitment rate; a lower than anticipated observed cardiovascular event rate. The Sponsor decision to stop the trial was not based on any safety concerns or any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2016-01-22', 'resultsFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2016-01-22', 'lastUpdatePostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-28', 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Composite MACE endpoint was defined as: death due to any cause, non-fatal myocardial infarction or non-fatal stroke.\n\nKaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) occurrence of composite MACE over time. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'Time From Randomization to the First Confirmed (Adjudicated) Occurrence of Cardiovascular (CV)-Related Death, Non-fatal Myocardial Infarction or Non-fatal Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) occurrence of CV-related death, non-fatal myocardial infarction or non-fatal stroke. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.'}, {'measure': 'Time From Randomization to Confirmed (Adjudicated) CV-related Death; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) CV-related death. Percentage of observed subjects with outcome measure events during the trial are reported. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.'}, {'measure': 'Time From Randomization to the First Confirmed (Adjudicated) Myocardial Infarction; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) myocardial infarction. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.'}, {'measure': 'Time From Randomization to the First Confirmed (Adjudicated) Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) stroke. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.'}, {'measure': 'Time From Randomization to the First Confirmed (Adjudicated) Unstable Angina Requiring Hospitalization; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) unstable angina requiring hospitalization. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.'}, {'measure': 'Time From Randomization to Death Due to Any Cause; Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'timeFrame': 'Randomization to Day 336 (end-of-trial)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict death due to any cause. Percentage of observed subjects with outcome measure events during the trial are reported.\n\nSubjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.'}, {'measure': 'Testosterone Levels at Days 28, 168 and 336 in the Degarelix and Leuprolide Treatment Groups', 'timeFrame': 'Days 28, 168 and 336 (end-of-trial)', 'description': 'Median levels and interquartile ranges for serum testosterone at Days 28, 168, and 336 are presented.'}, {'measure': 'Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial', 'timeFrame': 'From randomization to end-of-trial for each subject (subjects not censored at Day 336)', 'description': 'Time to failure in PFS was defined as the time, measured in days, from randomization to the first occurrence of either death, radiographic disease progression, introduction of additional prostate cancer therapies for progression, or PSA failure.\n\nSubjects who discontinued treatment with IMP or withdrew from the trial were censored at the time of discontinuation/withdrawal.\n\nKaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict failure in PFS. Percentage of observed subjects with outcome measure events during the trial are reported.'}, {'measure': 'Changes From Baseline in International Prostate Symptom Score (IPSS) Total and Quality of Life (QoL) Scores', 'timeFrame': 'Baseline to Days 168 and 336 (end-of-trial)', 'description': "Lower urinary tract symptoms were measured with the IPSS Version 1 (IPSS-1). The IPSS is a subject-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question was assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS-1 score was then calculated as summation over the responses for all 7 questions. The total IPSS-1 score was transformed to a scale from 0 (lowest score) to 100 (highest score). Higher scores reflect higher severity of symptoms. The IPSS-1 included an additional single question to assess a subject's QoL in relation to his urinary symptoms; response to this question was analyzed separately and was not included in the total IPSS score. The score was similarly scaled from 0 to 100.\n\nChange from baseline in IPSS Total and QoL scores are presented."}, {'measure': 'Total Number of CV-related Hospitalization Events Over the Duration of the Trial', 'timeFrame': 'First dose of IMP to Day 336 (end-of-trial)', 'description': 'The total number of CV-related hospitalizations over the duration of the trial was defined as the number of hospitalizations due to CV-related adverse events, observed from the first exposure to IMP up until Day 336 for each subject.'}, {'measure': 'Total Number of Coronary Artery By-pass Grafting (CABG) or Percutaneous Coronary Intervention (PCI) Procedures Over the Duration of the Trial', 'timeFrame': 'First dose of IMP to Day 336 (end-of-trial)', 'description': 'The total number of CABG or PCI procedures observed for each subject over the duration of the trial'}, {'measure': 'Total Number of CV-related Emergency Room (ER) Visit Events Over the Duration of the Trial', 'timeFrame': 'First dose of IMP to Day 336 (end-of-trial)', 'description': 'CV-related ER visit events (that did not lead to hospitalization) was observed from the first exposure to IMP up until Day 336 for each subject.'}, {'measure': 'Change in Utility, Based on EuroQol Group 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)', 'timeFrame': 'Baseline to Day 336 (end-of-trial)', 'description': 'The EQ-5D-5L essentially consists of 2 systems - the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS is an overall estimation of the present health status. The results from the EQ-5D-5L questionnaire were converted into quality adjusted life year (QALY) units.\n\nThe QALY is estimated by combining the value of life (utility value) and length of life. Quality adjusted life years are based on a principle assuming that a year of life lived in perfect health is worth 1 QALY and that a year of life lived in a state of less than perfect health is worth less than 1.'}, {'measure': 'Changes From Baseline in Duke Activity Status Index (DASI) Global Score', 'timeFrame': 'Baseline to Days 168 and 336 (end-of-trial)', 'description': "The DASI is a self-administered instrument developed to measure functional capacity in subjects with cardiovascular disease (CVD). It contains 12 items referring to the present time, assessing the ability to perform physical tasks in five domains: personal care (1 item), ambulation (4 items), household tasks (4 items), sexual function (1 item) and recreation (2 items). Each question was answered by one of four options: 'yes with no difficulty' / 'yes, but with some difficulty' / 'no, I can't do this' / 'don't do this for other reasons'. A global score was calculated with a higher score indicating a higher functional capacity. The minimum score is 0 and the maximum score is 58.2 points.\n\nChange from baseline in DASI Global score is presented."}, {'measure': 'Changes From Baseline in Cardiac Anxiety Questionnaire (CAQ) Global Score and Score Per Domain', 'timeFrame': 'Baseline to Days 168 and 336 (end-of-trial)', 'description': 'The CAQ is a self-administered questionnaire developed to measure heart-focused anxiety in persons with or without heart disease. It contains 18 items referring to the present time assessing cardiac anxiety in three domains: fear (8 items, each item could be scored between 0 "never" to 4 "always", maximum total score 32), avoidance (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20) and attention (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20). A higher score indicated greater cardiac anxiety and the total score range was between 0 and 72.\n\nChange from baseline in CAQ Global score and score per domain are presented.'}, {'measure': 'Number of Subjects With Adverse Events (AEs)', 'timeFrame': 'Start of IMP treatment until 3 months after last dosing of IMP', 'description': "Adverse events were recorded from signed informed consent until end-of-trial. Adverse events with onset after start of IMP treatment, and within 3 months after (1 month=28 days) last dosing of IMP, were considered 'treatment-emergent' and are presented for the safety analysis set."}, {'measure': 'Intensity of AEs', 'timeFrame': 'Start of IMP treatment until 3 months after last dosing of IMP', 'description': 'The intensity of AE was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.02) 5-point scale.\n\nAE were categorized as grade 1 Mild (minor; no specific medical intervention; asymptomatic laboratory findings only; marginal clinical relevance), Grade 2 Moderate (minimal intervention: local intervention; non-invasive intervention), Grade 3 Severe (significant symptoms, requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation), Grade 4 Life-threatening or disabling (complicated by acute, life-threatening metabolic or CV complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation) and Grade 5 Death. Events with grades 3, 4 and 5 were categorized as severe.'}, {'measure': 'Changes in Vital Signs', 'timeFrame': 'Baseline to Day 336 (end-of-trial)', 'description': 'Number of subjects shifting from normal value(s) in vital signs (pulse and blood pressure) at baseline to clinically significant abnormal value(s) at end-of-trial are presented.\n\nNote: Only subjects with appropriate baseline and post-baseline data are included in the evaluation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '34459214', 'type': 'DERIVED', 'citation': 'Lopes RD, Higano CS, Slovin SF, Nelson AJ, Bigelow R, Sorensen PS, Melloni C, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Clarke NW, Olesen TK, Doyle-Olsen BT, Kristensen H, Arney L, Roe MT, Alexander JH; PRONOUNCE Study Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021 Oct 19;144(16):1295-1307. doi: 10.1161/CIRCULATIONAHA.121.056810. Epub 2021 Aug 30.'}, {'pmid': '34396210', 'type': 'DERIVED', 'citation': 'Melloni C, Slovin SF, Blemings A, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Zubovskiy K, Olesen TK, Dugi K, Clarke NW, Higano CS, Roe MT; PRONOUNCE Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design. JACC CardioOncol. 2020 Mar 17;2(1):70-81. doi: 10.1016/j.jaccao.2020.01.004. eCollection 2020 Mar.'}, {'pmid': '34350976', 'type': 'DERIVED', 'citation': 'Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced prostate cancer\n* Indication to initiate androgen deprivation therapy (ADT)\n* Predefined cardiovascular disease\n\nExclusion Criteria:\n\n* Previous or current hormonal management of prostate cancer (unless terminated at least 12 months prior to trial)\n* Acute cardiovascular disease in the previous 30 days'}, 'identificationModule': {'nctId': 'NCT02663908', 'acronym': 'PRONOUNCE', 'briefTitle': 'A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)', 'orgStudyIdInfo': {'id': '000108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Degarelix', 'interventionNames': ['Drug: Degarelix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Leuprolide', 'interventionNames': ['Drug: Leuprolide']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FIRMAGON'], 'armGroupLabels': ['Degarelix']}, {'name': 'Leuprolide', 'type': 'DRUG', 'otherNames': ['LUPRON DEPOT'], 'armGroupLabels': ['Leuprolide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Urology Center of Alabama PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Institute of Urology', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Urological Associates of Southern Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona College of Medicine', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Urology Associates, PA', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Medical Center, Inc.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Clinical Trials', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Skyline Urology', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Innovative Clinical Research Institute', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80211', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Urology Center of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Urologic Surgeons of Washington', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'San Marcus Research Clinic Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Comprehensive Cancer Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33060', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Center of Florida', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '33615', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Urology Partners', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60010', 'city': 'Lake Barrington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Comprehensive Urologic Care', 'geoPoint': {'lat': 42.21252, 'lon': -88.15258}}, {'zip': '62703', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Springfield Clinic LLP', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46032', 'city': 'Greenwood', 'state': 'Indiana', 'country': 'United States', 'facility': 'Urology of Indiana LLC', 'geoPoint': {'lat': 39.61366, 'lon': -86.10665}}, {'zip': '47130', 'city': 'Jeffersonville', 'state': 'Indiana', 'country': 'United States', 'facility': 'First Urology PSC', 'geoPoint': {'lat': 38.27757, 'lon': -85.73718}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Clinic', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center Research Institute, Inc.', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Urology Care', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Regional Urology, LLC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Urology Associates, P.A.', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '08054', 'city': 'Mount Laurel', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Delaware Valley Urology LLC Westhampton', 'geoPoint': {'lat': 39.934, 'lon': -74.891}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Holy Name Medical Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Urology Group of New Mexico PC', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11003', 'city': 'Elmont', 'state': 'New York', 'country': 'United States', 'facility': 'Advanced Urology Centers of New York Elmont Division', 'geoPoint': {'lat': 40.70094, 'lon': -73.71291}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center PRIME', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center-Salisbury, NC', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '45409', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Signal Point Clinical Research Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Research Solutions PC', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '19004', 'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Urologic Consultants of Southeaster PA LLP', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'zip': '17604', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster Urology', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VA Medical Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina (MUSC)', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Erlanger Health System', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '23462', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Urology of Virginia', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98166', 'city': 'Burien', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Urology Research Center', 'geoPoint': {'lat': 47.47038, 'lon': -122.34679}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington School of Medicine', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin, Inc.', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Male Health Centre Euroscope Inc', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'J. Giddens Medicine Professional Corporation', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'G. 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