TABLE 2.
Number (%) of participants with treatment-emergent adverse events by pooled treatment with nifedipine GITS (20, 30, 60 mg) monotherapy, candesartan cilexetil (4, 8, 16, 32 mg) monotherapy, combination or placebo (N = 1381)
| Placebo (n = 88) | Candesartan cilexetil monotherapy (n = 346) | Nifedipine GITS monotherapy (n = 254) | Nifedipine GITS-candesartan cilexetil combination (n = 693) | Total (N = 1381) | |
| Any TEAE | 25 (28.4) | 110 (31.8) | 109 (42.9) | 292 (42.1) | 536 (38.8) |
| Any study drug-related TEAE | 9 (10.2) | 36 (10.4) | 52 (20.5) | 127 (18.3) | 224 (16.2) |
| Discontinuation of study drug due to TEAEs | 1 (1.1) | 3 (0.9) | 9 (3.5) | 20 (2.9) | 33 (2.4) |
| Vasodilatory TEAEs | 10 (11.4) | 41 (11.8) | 60 (23.6) | 127 (18.3) | 238 (17.2) |
| Oedema | 4 (4.5) | 30 (8.7) | 36 (14.2) | 89 (12.8) | 159 (11.5) |
| Headache | 6 (6.8) | 12 (3.5) | 28 (11.0) | 38 (5.5)a | 84 (6.1) |
| Flushing | 0 | 0 | 1 (0.4) | 6 (0.9) | 7 (0.5) |
TEAE, treatment-emergent adverse event.
a
P = 0.003 versus monotherapy.