{"description":"All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":155,"description":"Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals.\n\nSOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.","id":"EG000","otherNumAffected":30,"otherNumAtRisk":155,"seriousNumAffected":2,"seriousNumAtRisk":155,"title":"SOV2012-F1-treated"}],"frequencyThreshold":"2","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":155,"numEvents":4}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":155,"numEvents":8}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":155,"numEvents":5}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":155,"numEvents":4}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":155,"numEvents":3}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Event judged as treatment related by investigator.","organSystem":"Investigations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":155,"numEvents":3}],"term":"Hemoglobin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":155,"numEvents":3}],"term":"Headache"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Event judged not treatment related by investigator.","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":155,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Event judged not treatment related by investigator.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":155,"numEvents":1}],"term":"Diverticular perforation"}],"timeFrame":"180 days"}