{"description":"Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.\n\nIn total, 125 (83.3%) patients had TEAEs during the study.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":150,"description":"Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.\n\nTestosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg","id":"EG000","otherNumAffected":125,"otherNumAtRisk":150,"seriousNumAffected":3,"seriousNumAtRisk":150,"title":"Testosterone Enanthate Auto-injector"}],"frequencyThreshold":"2","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":150,"numEvents":21}],"term":"Hematocrit increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":150,"numEvents":18}],"term":"Prostatic specific antigen increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":150,"numEvents":5}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":150,"numEvents":4}],"term":"Blood testosterone increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":150,"numEvents":12}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":150,"numEvents":11}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":150,"numEvents":6}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":150,"numEvents":5}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":150,"numEvents":4}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":150,"numEvents":4}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":150,"numEvents":10}],"term":"Injection site bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":150,"numEvents":5}],"term":"Injection site hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":150,"numEvents":4}],"term":"Injection site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":150,"numEvents":4}],"term":"Edema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150,"numEvents":3}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":150,"numEvents":4}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150,"numEvents":3}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":150,"numEvents":19}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":150,"numEvents":5}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150,"numEvents":3}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":150,"numEvents":4}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150,"numEvents":3}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150,"numEvents":3}],"term":"Sleep apnea syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150,"numEvents":3}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150,"numEvents":3}],"term":"Hemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":150,"numEvents":8}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":150,"numEvents":4}],"term":"Prostatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150,"numEvents":3}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150,"numEvents":3}],"term":"Polycythemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Worsening depressive disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150,"numEvents":1}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"SUICIDE, METHOD UNKNOWN","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150,"numEvents":1}],"term":"Suicide"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150,"numEvents":1}],"term":"Vertigo"}],"timeFrame":"Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 weeks"}