Table 3.
Adverse events occurring in >5% of participants classified in MedDRA categories.
| Bumetanide group (n = 19) | Placebo group (n = 19) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Symptom | # of AEs | # of part. | Severity | IRa | # of AEs | # of part. | Severity | p-value | |
| Total AE | 100 | 19 | 61 | 17 | |||||
| Metabolism and nutrition disorders | |||||||||
| Hypokalemia | 9 | 5 | Moderate | 1 | 0.0463 | ||||
| Dehydration | 3 | 3 | Moderate | 1 | 0.230 | ||||
| Hypoglycemia | 2 | 1 | Mild | 3 | 1.000 | ||||
| Hyponatremia | 2 | 1 | Moderate | 2 | 1.000 | ||||
| Gastrointestinal disorders | |||||||||
| Vomiting | 3 | 3 | Mild | 2 | 3 | 3 | Mild | 1.000 | |
| Nausea | 7 | 6 | Mild | 2 | 3 | 2 | Mild | 0.232 | |
| Abdominal pain | 7 | 6 | Mild | 3 | 3 | 3 | Mild | 0.447 | |
| Obstipation | 2 | 2 | Moderate | 0.487 | |||||
| Gastroenteritis | 3 | 3 | Mild | 3 | 4 | 4 | Mild | 1.000 | |
| Vascular disorder | |||||||||
| Orthostatic hypotension | 9 | 8 | Mild | 1 | 3 | 3 | Mild | 0.151 | |
| Infections and infestations | |||||||||
| Common cold | 3 | 3 | Mild | 3 | 14 | 10 | Mild | 0.0382 | |
| Musculoskeletal and connective tissue disorders | |||||||||
| Myalgia | 10 | 7 | Mild | 2 | 3 | 3 | Mild | 0.269 | |
| Muscle cramp | 2 | 2 | Mild | 2 | 2 | 1 | Mild | 1.000 | |
| Renal and urinary disorders | |||||||||
| Dysuria | 2 | 2 | Mild | 2 | 1.000 | ||||
| Enuresisb | 1 | 1 | Mild | 1 | 1.000 | ||||
| Increased diuresis | 6 | 6 | Mild | 1 | 0.0197 | ||||
| Nervous system disorders | |||||||||
| Headache | 6 | 4 | Mild | 3 | 7 | 7 | Moderate | 0.476 | |
| Dizziness | 2 | 2 | Mild | 3 | 2 | 2 | Mild | 1.000 | |
| Psychiatric disorders | |||||||||
| Insomnia | 1 | 1 | Mild | 3 | 4 | 4 | Mild | 0.340 | |
| General disorders and administration site conditions | |||||||||
| Fatigue | 4 | 3 | Mild | 2 | 2 | 2 | Mild | 1.000 | |
| Skin and subcutaneous tissue disorders | |||||||||
| Dermal abnormalities | 3 | 3 | Moderate | 3 | 2 | 2 | Moderate | 1.000 | |
| Injury, poisoning and procedural complications | |||||||||
| Injury | 4 | 4 | Moderate | 3 | 0.105 | ||||
Data are n. Differences were tested with Fisher Exact tests. #, number; AE, adverse event; IR, intervention relationship; Part, participants.
a
1, definitely related; 2, possibly related; 3, not related.
b
Occurring in <5% of participants, but listed as important expected AE. Significance level is p < 0.05.