Table 2

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

Bromocriptine-QRPlacebo
n2,0541,016
SAEs by SOC*
    Cardiac**51 (2.5)37 (3.6)
    Infections and infestations27 (1.3)13 (1.3)
    Nervous system disorders26 (1.3)14 (1.4)
    General disorders14 (0.7)9 (0.9)
    Gastrointestinal disorders13 (0.6)9 (0.9)
    Vascular disorders10 (0.5)8 (0.8)
    Respiratory, thoracic and mediastinal13 (0.6)3 (0.3)
    Injury, poisoning, and procedural complications12 (0.6)3 (0.3)
    Musculoskeletal and connective tissue11 (0.5)4 (0.4)
    Neoplasm benign, malignant, and unspecified8 (0.4)2 (0.2)
    Endocrine5 (0.2)4 (0.4)
        Hypoglycemia4 (0.2)4 (0.4)
    Metabolism and nutrition disorders7 (0.3)2 (0.2)
    Renal and urinary disorders6 (0.3)3 (0.3)
    Hepatobiliary disorders4 (0.2)1 (0.1)
    Psychiatric disorders4 (0.2)1 (0.1)
    Reproductive system and breast disorders4 (0.2)0
    Eye disorders02 (0.2)
Any SAE176 (8.6)98 (9.6)
    Hazard ratio and 96% one-sided confidence limit1.02 (—, 1.27)
Prespecified adjudicated composite cardiovascular endpoint
    Time to first composite CVD event37 (1.8%)32 (3.1%)
Hazard ratio and 95% confidence limit0.60 (0.37–0.96)
    Composite CVD end point by each component
Myocardial infarction7 (0.3)9 (0.9)
Stroke5 (0.2)6 (0.6)
Hospitalization for unstable angina9 (0.4)9 (0.9)
Hospitalization for congestive heart failure9 (0.4)6 (0.4)
Coronary revascularization11 (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.