Table 2.
Selected Adverse Events Leading to Discontinuation of a Study Drug.
Adverse Event | Telmisartan (N = 10,146) |
Placebo (N = 10,186) |
P Value |
---|---|---|---|
no. (%) | |||
Total | 1450 (14.3) | 1127 (11.1) | <0.001 |
Hypotensive symptoms | 393 (3.9) | 186 (1.8) | <0.001 |
Syncope | 21 (0.2) | 6 (0.1) | 0.004 |
Uncontrolled hypertension | 13 (0.1) | 17 (0.2) | 0.47 |
Headache | 231 (2.3) | 203 (2.0) | 0.16 |
Diarrhea | 69 (0.7) | 45 (0.4) | 0.02 |
Nausea | 104 (1.0) | 72 (0.7) | 0.01 |
Vomiting | 74 (0.7) | 61 (0.6) | 0.25 |
Angioedema | 23 (0.2) | 31 (0.3) | 0.28 |
Renal impairment | 28 (0.3) | 18 (0.2) | 0.14 |
Hyperkalemia | 14 (0.1) | 6 (0.1) | 0.07 |
Atrial fibrillation | 81 (0.8) | 50 (0.5) | 0.006 |