Table 3.
Incidence rate of adverse drug reactions by the timing of occurrence reported by physicians (≥ 0.5%)
| Preferred term, n (%) | Total (N = 1109) | 1–3 days (N = 1109) | 4–7 days (N = 1088) | 8–14 days (N = 992) | 15–30 days (N = 782) | > 31 days (N = 588) | Unknown |
|---|---|---|---|---|---|---|---|
| Thirst | 73 (6.6) | 53 (4.8) | 15 (1.4) | 1 (0.1) | 1 (0.1) | 2 (0.3) | 1 |
| Hepatic encephalopathy | 25 (2.3) | 2 (0.2) | 5 (0.5) | 3 (0.3) | 5 (0.6) | 10 (1.7) | 0 |
| Dehydration | 17 (1.5) | 2 (0.2) | 4 (0.4) | 3 (0.3) | 4 (0.5) | 4 (0.7) | 0 |
| Hypernatremia | 13 (1.2) | 6 (0.5) | 4 (0.4) | 3 (0.3) | 0 | 0 | 0 |
| Renal impairment | 11 (1.0) | 3 (0.3) | 1 (0.1) | 4 (0.4) | 1 (0.1) | 2 (0.3) | 0 |
| Hyperkaliemia | 9 (0.8) | 1 (0.1) | 4 (0.4) | 2 (0.2) | 0 | 2 (0.3) | 0 |
| Blood urea increased | 8 (0.7) | 0 | 3 (0.3) | 4 (0.4) | 0 | 1 (0.2) | 0 |
| Blood creatinine increased | 7 (0.6) | 0 | 1 (0.1) | 3 (0.3) | 0 | 3 (0.5) | 0 |