Research Article
A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients with Essential Hypertension and Type 2 Diabetes in Asia
Table 4
Frequency of AEs : safety analysis set and overall population.
| | AEs | Overall (N = 380) | | Before week 6 n = 380 | After week 6 n = 355 | Total (N = 380) | | AZL-M 40 mg (n = 380) | AZL-M 40 mg (n = 258) | AZL-M 80 mg (n = 97) | Total (n = 355) | | | Events n | Patients, n (%) | Events n | Patients, n (%) | Events n | Patients, n (%) | Events n | Patients, n (%) | Events n | Patients, n (%) |
| | TEAEs | 78 | 49 (12.9) | 70 | 40 (15.5) | 29 | 17 (17.5) | 99 | 57 (16.1) | 193 | 100 (26.3) | | Related to AZL-M | 23 | 19 (5) | 15 | 12 (4.7) | 2 | 2 (2.1) | 17 | 14 (3.9) | 41 | 32 (8.4) | | Not related to AZL-M | 55 | 37 (9.7) | 55 | 30 (11.6) | 27 | 15 (15.5) | 82 | 45 (12.7) | 152 | 79 (20.8) | | Related to study procedures | 1 | 1 (0.3) | 1 | 1 (0.4) | 0 | 0 | 1 | 1 (0.3) | 2 | 2 (0.5) | | Not related to study procedures | 77 | 48 (12.6) | 69 | 39 (15.1) | 29 | 17 (17.5) | 98 | 56 (15.8) | 191 | 98 (25.8) | | Leading to study drug discontinuation | 14 | 14 (3.7) | 4 | 3 (1.2) | 0 | 0 | 4 | 3 (0.8) | 18 | 17 (4.5) | | Mild | 70 | 44 (11.6) | 60 | 32 (12.4) | 20 | 15 (15.5) | 80 | 47 (13.2) | 164 | 86 (22.6) | | Moderate | 3 | 3 (0.8) | 8 | 6 (2.3) | 6 | 4 (4.1) | 14 | 10 (2.8) | 19 | 13 (3.4) | | Severe | 5 | 5 (1.3) | 2 | 2 (0.8) | 3 | 1 (1) | 5 | 3 (0.8) | 10 | 8 (2.1) | | Serious TEAEs | 4 | 4 (1.1) | 3 | 3 (1.2) | 3 | 1 (1) | 6 | 4 (1.1) | 10 | 8 (2.1) | | Deaths | 1 | 1 (0.3) | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (0.3) |
|
|
270 AE, adverse event; AZL-M, azilsartan medoxomil; TEAE, treatment-related adverse event.
|
