Table 5 Summary of AEs (safety population)
Parameter, n (%) | Diabetes n = 245 | No diabetes n = 1802 | P valuea |
|---|---|---|---|
Any AE | 120 (49.0) | 673 (37.3) | 0.00046 |
Any serious AE | 26 (10.6) | 82 (4.6) | 0.00007 |
Any treatment-related AE | 20 (8.2) | 182 (10.1) | 0.34038 |
Any treatment-related serious AE | 0 (0.0) | 4 (0.2) | 0.46052 |
Any AE leading to discontinuation of study drug | 8 (3.3) | 32 (1.8) | 0.11411 |
Any treatment-related AE leading to discontinuation of study drug | 3 (1.2) | 13 (0.7) | 0.40162 |
Any AE resulting in death | 6 (2.4) | 14 (0.8) | 0.01256 |
Any treatment-related AE resulting in death | 0 (0.0) | 0 (0.0) | 1.00000 |
System organ class AEs with significant difference between groups | |||
Infections and infestations | 29 (11.8) | 137 (7.6) | 0.02277 |
Differencea (95% CI) | −4.2 (−9.0, −0.5) | ||
Vascular disorders | 18 (7.3) | 69 (3.8) | 0.01046 |
Differencea (95% CI) | −3.5 (−7.6, −0.7) | ||