Table 8.
Incidence of adverse drug reactions (ADRs) reported in the safety analysis population (n = 2,590)
| Parameter | n [%] |
|---|---|
| No. of patients who developed an ADR | 81 [3.13] |
| Total no. of ADRsa | 103 |
| No. of ADRsa commonly associated with calcium antagonists | 34 |
| Dizziness | 13 [0.50] |
| Headache | 8 [0.31] |
| Palpitations | 5 [0.19] |
| Hot flushes | 4 [0.15] |
| Edema | 4 [0.15] |
aThese ADRs are classified according to their Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms