Comparative Outcomes Study of Metformin Intervention Versus Conventional Approach The COSMIC Approach Study

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
Metformin Usual care Metformin Usual care Metformin Usual care
n 7,227 1,505 4,710 935 2,515 569
Any SAE 747 (10.3) 166 (11.0) 375 (8.0) 73 (7.8) 371 (14.8) 93 (16.3)
Cardiac disorders 237 (3.3) 49 (3.3) 96 (2.0) 17 (1.8) 141 (5.6) 32 (5.6)
Gastrointestinal disorders 88 (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 infestations 121 (1.7) 32 (2.1) 49 (1.0) 10 (1.1) 72 (2.9) 22 (3.9)
Metabolism and nutritional disorders 70 (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 disorders 92 (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.

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  1. Diabetes Care March 2005 vol. 28 no. 3 539-543
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