Table 1. Drug-related AEs in ⩾5 patients.
|
Bumetanide 0.5 mg b.i.d. (N=20) |
Bumetanide 1 mg b.i.d. (N=23) |
Bumetanide 2 mg b.i.d. (N=21) |
Placebo (N=22) |
|||||
|---|---|---|---|---|---|---|---|---|
| n | N (%) | n | N (%) | n | N (%) | n | N (%) | |
| Hypokalemia | 6 | 6 (30%) | 20 | 14 (60.9%) | 22 | 16 (76.2%) | 0 | 0 |
| Diuresis, enuresis, polyuria, pollakiuria | 4 | 2 (10%) | 12 | 8 (34.8%) | 13 | 11 (52.4%) | 0 | 0 |
| Loss of appetite/anorexia | 0 | 0 | 7 | 7 (30.4%) | 9 | 9 (42.9%) | 0 | 0 |
| Dehydration | 0 | 0 | 3 | 3 (13.0%) | 6 | 6 (28.6%) | 0 | 0 |
| Asthenia | 2 | 2 (10%) | 2 | 2 (8.7%) | 4 | 3 (14.3%) | 0 | 0 |
| Weight loss | 0 | 0 | 3 | 3 (13.0%) | 3 | 3 (14.3%) | 0 | 0 |
| Vomiting | 0 | 0 | 1 | 1 (4.3%) | 5 | 5 (23.8%) | 0 | 0 |
| Diarrhea/liquid stools | 0 | 0 | 4 | 2 (8.7%) | 0 | 0 | 3 | 3 (13.6%) |
| Fatigue | 0 | 0 | 1 | 1 (4.3%) | 4 | 4 (19.0%) | 0 | 0 |
| Abdominal pain/belly pain | 2 | 1 (5%) | 1 | 1 (4.3%) | 2 | 2 (9.5%) | 0 | 0 |
| Hyperuricemia | 2 | 1 (5%) | 3 | 3 (13.0%) | 1 | 1 (4.8%) | 0 | 0 |
| Thirst/polydipsia | 1 | 1 (5%) | 2 | 2 (8.7%) | 2 | 2 (9.5%) | 0 | 0 |
Abbreviations: AEs, adverse events; n, number of events; N, Number of patients; %, percentage of patients.
The main treatment emergent adverse events (TEAEs) reported in at least five patients in all treatment groups during the randomized phase (incidence reported in % of bumetanide- and placebo-treated patients). Patients with multiple TEAEs within the same category were counted only once towards category total.