Table 6

AEs Reported in Fixed-Dose Combination and Usual Care Groups During the Trial, Phase 2

ControlPolypill
Reported AE112 (32.5)124 (35.4)
Reported SAE23 (6.6)21 (6.0)
Patients interrupting treatment because of AE13 (3.7)14 (4.0)
Death1 (0.3)1 (0.3)
Reinfarction2 (0.6)2 (0.6)
Hospitalization23 (6.7)21 (6.0)
Hematological AE6 (1.7)5 (1.4)
Other cardiac AE4 (1.1)10 (2.8)
Musculoskeletal AE10 (3.8)5 (1.4)
Cough6 (1.7)5 (1.4)
Dizziness2 (0.6)2 (0.6)
Hypotension7 (0.2)0 (0.0)

Values are n (%).

AE = adverse event(s).

  • Control (cancer); polypill (traffic accident).

  • Other cardiac AE: for example, nonspecific angina.