Ramipril (n = 1,350) | Diuretic (n = 661) | |||
---|---|---|---|---|
Type of adverse event | n | % | n | % |
No AE | 962 | 71.3 | 463 | 70.0 |
Any AE | 388 | 28.7 | 198 | 30.0 |
Serious AE | 168 | 12.4 | 101 | 15.3 |
Not serious | 345 | 25.6 | 176 | 26.6 |
MedDRA ® primary System Organ Classes (SOC) V. 11.1 - (Serious) Adverse Events, n = 2011 (%) | Ramipril | Diuretic | ||
AE | SAE | AE | SAE | |
Musculosceletal and connective tissue disorders | 6.52 | 0.74 | 11.95 | 0.61 |
Infections and infestations | 6.22 | 0.37 | 9.98 | 0.45 |
Metabolism and nutrition disorders | 5.78 | 0.22 | 8.02 | 1.06 |
Respiratory, thoracic and mediastinal disorders | 5.93 | 0.22 | 3.03 | 0.45 |
Nervous system disorders | 3.41 | 1.70 | 6.66 | 3.78 |
Gastrointestinal disorders | 3.48 | 1.04 | 4.24 | 1.36 |
Cardiac disorders | 3.04 | 2.74 | 4.54 | 3.18 |
Vascular disorders | 3.26 | 1.48 | 2.57 | 1.36 |
General disorders and administration site conditions | 2.07 | 1.93 | 3.48 | 3.03 |
Injury, poisoning and procedural complications | 2.22 | 1.04 | 3.18 | 1.36 |
Surgical and medical procedures | 2.00 | 0.89 | 2.87 | 1.51 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1.93 | 2.22 | 2.12 | 2.12 |