Table 4.
Incidence of drug‐related adverse events associated with valsartan
| System organ class/preferred term | Maximal‐tolerated‐dose group (n = 314) | Low‐dose group (n = 145) | ||||
|---|---|---|---|---|---|---|
| n | (%) | [Cases] | n | (%) | [Cases] | |
| Nervous system disorders | 13 | (4.14) | [13] | 0 | (0.00) | [0] |
| Dizziness | 11 | (3.50) | [11] | 0 | (0.00) | [0] |
| Dizziness postural | 2 | (0.64) | [2] | 0 | (0.00) | [0] |
| Vascular disorders | 7 | (2.23) | [7] | 0 | (0.00) | [0] |
| Hypotension | 5 | (1.59) | [5] | 0 | (0.00) | [0] |
| Orthostatic hypotension | 2 | (0.64) | [2] | 0 | (0.00) | [0] |
| Gastrointestinal disorders | 2 | (0.64) | [2] | 0 | (0.00) | [0] |
| Abdominal pain upper | 1 | (0.32) | [1] | 0 | (0.00) | [0] |
| Diarrhoea | 1 | (0.32) | [1] | 0 | (0.00) | [0] |
| General disorders and administration site conditions | 2 | (0.64) | [2] | 0 | (0.00) | [0] |
| Asthenia | 1 | (0.32) | [1] | 0 | (0.00) | [0] |
| Chest discomfort | 1 | (0.32) | [1] | 0 | (0.00) | [0] |
| Investigations | 2 | (0.64) | [2] | 0 | (0.00) | [0] |
| Blood creatinine increased | 1 | (0.32) | [1] | 0 | (0.00) | [0] |
| Haemoglobin decreased | 1 | (0.32) | [1] | 0 | (0.00) | [0] |
| Respiratory, thoracic, and mediastinal disorders | 1 | (0.32) | [1] | 1 | (0.69) | [1] |
| Cough | 1 | (0.32) | [1] | 0 | (0.00) | [0] |
| Oropharyngeal pain | 0 | (0.00) | [0] | 1 | (0.69) | [1] |
| Metabolism and nutrition disorders | 1 | (0.32) | [1] | 0 | (0.00) | [0] |
| Hyperkalaemia | 1 | (0.32) | [1] | 0 | (0.00) | [0] |
| Renal and urinary disorders | 1 | (0.32) | [1] | 0 | (0.00) | [0] |
| Nephropathy | 1 | (0.32) | [1] | 0 | (0.00) | [0] |