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Table 2

SAEs by SOC and all-cause safety and composite cardiovascular end point

Bromocriptine-QRPlacebo
n 2,054 1,016 
SAEs by SOC*   
    Cardiac** 51 (2.5) 37 (3.6) 
    Infections and infestations 27 (1.3) 13 (1.3) 
    Nervous system disorders 26 (1.3) 14 (1.4) 
    General disorders 14 (0.7) 9 (0.9) 
    Gastrointestinal disorders 13 (0.6) 9 (0.9) 
    Vascular disorders 10 (0.5) 8 (0.8) 
    Respiratory, thoracic and mediastinal 13 (0.6) 3 (0.3) 
    Injury, poisoning, and procedural complications 12 (0.6) 3 (0.3) 
    Musculoskeletal and connective tissue 11 (0.5) 4 (0.4) 
    Neoplasm benign, malignant, and unspecified 8 (0.4) 2 (0.2) 
    Endocrine 5 (0.2) 4 (0.4) 
        Hypoglycemia 4 (0.2) 4 (0.4) 
    Metabolism and nutrition disorders 7 (0.3) 2 (0.2) 
    Renal and urinary disorders 6 (0.3) 3 (0.3) 
    Hepatobiliary disorders 4 (0.2) 1 (0.1) 
    Psychiatric disorders 4 (0.2) 1 (0.1) 
    Reproductive system and breast disorders 4 (0.2) 
    Eye disorders 2 (0.2) 
Any SAE 176 (8.6) 98 (9.6) 
    Hazard ratio and 96% one-sided confidence limit 1.02 (—, 1.27) 
Prespecified adjudicated composite cardiovascular endpoint   
    Time to first composite CVD event 37 (1.8%) 32 (3.1%) 
Hazard ratio and 95% confidence limit 0.60 (0.37–0.96) 
    Composite CVD end point by each component   
Myocardial infarction 7 (0.3) 9 (0.9) 
Stroke 5 (0.2) 6 (0.6) 
Hospitalization for unstable angina 9 (0.4) 9 (0.9) 
Hospitalization for congestive heart failure 9 (0.4) 6 (0.4) 
Coronary revascularization 11 (0.5) 8 (0.8) 
Bromocriptine-QRPlacebo
n 2,054 1,016 
SAEs by SOC*   
    Cardiac** 51 (2.5) 37 (3.6) 
    Infections and infestations 27 (1.3) 13 (1.3) 
    Nervous system disorders 26 (1.3) 14 (1.4) 
    General disorders 14 (0.7) 9 (0.9) 
    Gastrointestinal disorders 13 (0.6) 9 (0.9) 
    Vascular disorders 10 (0.5) 8 (0.8) 
    Respiratory, thoracic and mediastinal 13 (0.6) 3 (0.3) 
    Injury, poisoning, and procedural complications 12 (0.6) 3 (0.3) 
    Musculoskeletal and connective tissue 11 (0.5) 4 (0.4) 
    Neoplasm benign, malignant, and unspecified 8 (0.4) 2 (0.2) 
    Endocrine 5 (0.2) 4 (0.4) 
        Hypoglycemia 4 (0.2) 4 (0.4) 
    Metabolism and nutrition disorders 7 (0.3) 2 (0.2) 
    Renal and urinary disorders 6 (0.3) 3 (0.3) 
    Hepatobiliary disorders 4 (0.2) 1 (0.1) 
    Psychiatric disorders 4 (0.2) 1 (0.1) 
    Reproductive system and breast disorders 4 (0.2) 
    Eye disorders 2 (0.2) 
Any SAE 176 (8.6) 98 (9.6) 
    Hazard ratio and 96% one-sided confidence limit 1.02 (—, 1.27) 
Prespecified adjudicated composite cardiovascular endpoint   
    Time to first composite CVD event 37 (1.8%) 32 (3.1%) 
Hazard ratio and 95% confidence limit 0.60 (0.37–0.96) 
    Composite CVD end point by each component   
Myocardial infarction 7 (0.3) 9 (0.9) 
Stroke 5 (0.2) 6 (0.6) 
Hospitalization for unstable angina 9 (0.4) 9 (0.9) 
Hospitalization for congestive heart failure 9 (0.4) 6 (0.4) 
Coronary revascularization 11 (0.5) 8 (0.8) 

Data are n (%).

*SOC as determined by MedDRA coding of preferred term provided by study investigator. Patients may appear in more than one system organ category if they experienced multiple AEs belonging to different SOCs. All SAEs were adjudicated by an independent AEAC.

**The cardiac SOC includes 37 different preferred terms such as arrhythmia, myocardial infarction, chest pain, and coronary artery disease; however the composite cardiovascular end point comprised events that met the prespecified end point criteria set forth by an independent AEAC that was blinded to treatment assignment.

†Hypoglycemia is a subcategory of the endocrine SOC.

‡Patients may appear in more than one component of the composite cardiovascular end point if they experienced multiple cardiovascular AEs.

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