Table 3.
Most common (n > 1) AEs during blinded efficacy period (up to 28 days)
| System Organ Class | Amlodipine | Placebo | P‐valuea | ||||
|---|---|---|---|---|---|---|---|
| N = 42 | N = 35 | ||||||
| f | n | % | f | n | % | ||
| Any event | 23 | 12 | 28.6 | 17 | 10 | 28.6 | >.99 |
| Digestive tract disorders (ascites, diarrhea, emesis, gingival disorder, tooth disorder) | 6 | 5 | 11.9 | 5 | 4 | 11.4 | >.99 |
| Renal and urinary disorders (cystitis, nephritis, renal insufficiency, urine abnormalities) | 4 | 4 | 9.5 | 4 | 4 | 11.4 | >.99 |
| Systemic disorders (abscess, anorexia, death, lethargy, trauma, weight loss) | 2 | 2 | 4.8 | 4 | 2 | 5.7 | >.99 |
| Endocrine system disorders (hyperthyroidism, unspecified thyroid gland disorder) | 4 | 3 | 7.1 | 1 | 1 | 2.9 | .62 |
f, number of events; n, number of subjects; %, % of subjects.
a
P‐value from comparison of subject counts using Fisher's exact test.