Table 3 Adverse events considered drug-related observed during the double-blind treatment period in the safety analysis set, by primary system organ class
n (%) | Nifedipine CR 40 mg b.i.d. (N=177) | Nifedipine CR 40 mg q.d. (N=175) | Total (N=352) |
|---|---|---|---|
Total | 16 (9.0) | 17 (9.7) | 33 (9.4) |
Cardiac disorders | 1 (0.6) | 1 (0.6) | 2 (0.6) |
Palpitations | 0 | 1 (0.6) | 1 (0.3) |
Prinzmetal angina | 1 (0.6) | 0 | 1 (0.3) |
Gastrointestinal disorders | 3 (1.7) | 3 (1.7) | 6 (1.7) |
Constipation | 2 (1.1) | 2 (1.1) | 4 (1.1) |
Dyspepsia | 0 | 1 (0.6) | 1 (0.3) |
Gingival hypertrophy | 1 (0.6) | 0 | 1 (0.3) |
General disorders and administration site conditions | 1 (0.6) | 2 (1.1) | 3 (0.9) |
Peripheral edema | 1 (0.6) | 2 (1.1) | 3 (0.9) |
Hepatobiliary disorders | 1 (0.6) | 1 (0.6) | 2 (0.6) |
Abnormal hepatic function | 1 (0.6) | 1 (0.6) | 2 (0.6) |
Investigations | 3 (1.7) | 4 (2.3) | 7 (2.0) |
Increased ALT | 1 (0.6) | 0 | 1 (0.3) |
Increased alkaline phosphatase | 1 (0.6) | 0 | 1 (0.3) |
Decreased BP | 1 (0.6) | 0 | 1 (0.3) |
Blood urine present | 0 | 2 (1.1) | 2 (0.6) |
Decreased hemoglobin | 0 | 1 (0.6) | 1 (0.3) |
Increased platelet count | 0 | 1 (0.6) | 1 (0.3) |
Metabolism and nutrition disorders | 1 (0.6) | 2 (1.1) | 3 (0.9) |
Hyperuricaemia | 1 (0.6) | 0 | 1 (0.3) |
Hypokalaemia | 0 | 1 (0.6) | 1 (0.3) |
Type 2 diabetes mellitus | 0 | 1 (0.6) | 1 (0.3) |
Musculoskeletal and connective tissue disorders | 2 (1.1) | 0 | 2 (0.6) |
Arthralgia | 1 (0.6) | 0 | 1 (0.3) |
Muscle spasms | 1 (0.6) | 0 | 1 (0.3) |
Nervous system disorders | 4 (2.3) | 1 (0.6) | 5 (1.4) |
Dizziness | 0 | 1 (0.6) | 1 (0.3) |
Postural dizziness | 1 (0.6) | 0 | 1 (0.3) |
Headache | 3 (1.7) | 0 | 3 (0.9) |
Reproductive system and breast disorders | 1 (0.6) | 0 | 1 (0.3) |
Prostatitis | 1 (0.6) | 0 | 1 (0.3) |
Respiratory, thoracic and mediastinal disorders | 0 | 1 (0.6) | 1 (0.3) |
Allergic rhinitis | 0 | 1 (0.6) | 1 (0.3) |
Vascular disorders | 1 (0.6) | 2 (1.1) | 3 (0.9) |
Hot flush | 1 (0.6) | 1 (0.6) | 2 (0.6) |
Hypotension | 0 | 1 (0.6) | 1 (0.3) |
