Table 2—

Overall incidence of SAEs and summary of SAEs by system organ class (Medical Dictionary for Regulatory Affairs; SAEs in individual organ classes ≥1.0% in either group before stratification for age) in the metformin or usual care treatment groups: number and percent of patients

All patients
Age <65 years
Age ≥65 years
MetforminUsual careMetforminUsual careMetforminUsual care
n7,2271,5054,7109352,515569
Any SAE747 (10.3)166 (11.0)375 (8.0)73 (7.8)371 (14.8)93 (16.3)
Cardiac disorders237 (3.3)49 (3.3)96 (2.0)17 (1.8)141 (5.6)32 (5.6)
Gastrointestinal disorders88 (1.2)18 (1.2)44 (0.9)4 (0.4)44 (1.7)14 (2.5)
General disorders*158 (2.2)39 (2.6)60 (1.3)19 (2.0)98 (3.9)20 (3.5)
Infections and infestations121 (1.7)32 (2.1)49 (1.0)10 (1.1)72 (2.9)22 (3.9)
Metabolism and nutritional disorders70 (1.0)11 (0.7)35 (0.7)6 (0.6)34 (1.4)5 (0.9)
Neoplasms†92 (1.3)20 (1.3)41 (0.9)6 (0.6)51 (2.0)14 (2.5)
Vascular disorders92 (1.3)36 (2.4)40 (0.8)16 (1.7)52 (2.1)20 (3.5)
  • Data are n (%). *Includes administration site conditions; †benign, malignant, and unspecified (including cysts and polyps). Information on age was not captured for three patients (two in the metformin group and one in the usual care group); data for these patients are included in the ‘All patients’ section but not in the sections stratified for age at baseline.