Table 3.
Treatment-emergent adverse events occurring in ≥5 % of subjects following oral administration of metformin alone, trospium chloride XR alone, or metformin and trospium chloride XR in combination [n (%)]
| Adverse event | Metformin (n = 43) | Trospium chloride XR (n = 44) | Trospium chloride XR + metformin (n = 44) | Total (N = 44) |
|---|---|---|---|---|
| Headache | 4 (9) | 3 (7) | 7 (16) | 12 (27) |
| Diarrhoea | 3 (7) | 0 (0) | 3 (7) | 6 (14) |
| Abdominal distension | 1 (2) | 2 (5) | 0 (0) | 3 (7) |
| Abdominal pain, upper | 3 (7) | 0 (0) | 0 (0) | 3 (7) |
| Constipation | 1 (2) | 1 (2) | 1 (2) | 3 (7) |
| Dizziness | 1 (2) | 1 (2) | 1 (2) | 3 (7) |
| Dry throat | 1 (2) | 2 (5) | 0 (0) | 3 (7) |
| Nasal congestion | 0 (0) | 0 (0) | 3 (7) | 3 (7) |
| Abdominal pain | 0 (0) | 1 (2) | 2 (5) | 2 (5) |
| Dry lip | 2 (5) | 0 (0) | 0 (0) | 2 (5) |
| Metrorrhagia | 2 (5) | 0 (0) | 0 (0) | 2 (5) |
| Nausea | 2 (5) | 0 (0) | 1 (2) | 2 (5) |
| Oropharyngeal pain | 0 (0) | 1 (2) | 1 (2) | 2 (5) |
| Upper respiratory tract infection | 0 (0) | 0 (0) | 2 (5) | 2 (5) |
| Vomiting | 1 (2) | 0 (0) | 1 (2) | 2 (5) |
| White blood cells urine positive | 1 (2) | 1 (2) | 0 (0) | 2 (5) |
XR extended release