Table 3. Numbers and percentages of women with adverse events within each system organ class, overall and by treatment group.
| System organ class | Total (n = 255) | Hyoscine butylbromide (n = 129) | Placebo (n = 126) | p |
|---|---|---|---|---|
| Immune system disorders | 3 (1.2%) | 2 (1.6%) | 1 (0.8%) | 1.0002 |
| Dyspnoea | 1 | 1 | 0 | |
| Pruritus | 1 | 0 | 1 | |
| Chest discomfort | 1 | 1 | 0 | |
| Cough | 1 | 0 | 1 | |
| Neurological disorders | 11 (4.3%) | 5 (3.9%) | 6 (4.8%) | 0.7281 |
| Malaise | 2 | 1 | 1 | |
| Lightheadedness | 2 | 1 | 1 | |
| Headache | 3 | 2 | 1 | |
| Giddiness | 3 | 1 | 2 | |
| Trembling | 1 | 0 | 1 | |
| Eye disorders | 9 (3.5%) | 8 (6.2%) | 1 (0.8%) | 0.0362 |
| Visual disturbance | 9 | 8 | 1 | |
| Cardiac disorders | 54 (21.2%) | 51 (39.5%) | 3 (2.4%) | <0.0011 |
| Maternal tachycardia | 54 | 51 | 3 | |
| Vascular disorders | 6 (2.4%) | 2 (1.6%) | 4 (3.2%) | 0.4432 |
| Hypotension | 2 | 0 | 2 | |
| Hypertension | 1 | 1 | 0 | |
| Dizziness | 2 | 1 | 1 | |
| Flushing | 1 | 0 | 1 | |
| Gastrointestinal disorders | 13 (5.1%) | 8 (6.2%) | 5 (4.0%) | 0.4181 |
| Nausea | 5 | 2 | 3 | |
| Vomiting | 3 | 2 | 1 | |
| Dry mouth | 6 | 5 | 1 | |
| Renal and urinary disorders | 139 (54.5%) | 71 (55.0%) | 68 (54.0%) | 0.8641 |
| Urinary retention | 139 | 71 | 68 | |
| Other disorders | 2 (0.8%) | 1 (0.8%) | 1 (0.8%) | 1.0002 |
| Increased labor pain | 1 | 0 | 1 | |
| Uterine tachysystole | 1 | 1 | 0 |
1Pearson’s chi-square test.
2Fisher’s exact test.