Table 3. Moderate and Severe Adverse Events and Postvoid Residual Volume (PVR) among women in the Open Label Study (N=498).

Adverse Events†
Reported at least one moderate or severe adverse event, N (%)	241 (48.4)
Reported a potentially anticholinergic adverse event‡, N (%)	59 (11.9)
Reported a serious adverse event§, N (%)	26 (5.2)
Serious adverse event “possibly” related to treatment¶, N (%)	1 (0.2)
Postvoid Residual Volume ∥
Mean (SD) PVR volume	38.4 (48.3)
PVR volume ≥250 mL, N (%)	3 (0.6)

†Adverse events were assessed in the 498 women who took at least one dose of study drug and completed at least one follow-up visit. Common adverse events reported were (n): Dry mouth (30); Urinary tract infection (28); Cold/flu (25); Constipation (23); Dry throat (10); Back pain (9); Cough (8); Respiratory infection (8); Diarrhea (7); Headache (7); Runny/stuffy nose, sinus congestion (7); Bronchitis (5); Abdominal Pain (4); Allergy (4); Heartburn (4); Hematuria (4); Back strain (3); Chest pain (3); Dry eyes (3); Dyspepsia (3); Kidney infection (3); Pneumonia (3); Sciatica (3); Shortness of breath (3); Sinus infection (3); Vertigo (3); Weight gain (3)

^‡Potentially anticholinergic adverse events were defined a priori as constipation, dry mouth, or self-report urinary hesitancy or retention.

^§Serious adverse events were defined as adverse events that resulted in death, disability, or hospitalization.

^¶Serious adverse events “possibly” related to treatment were defined as serious adverse events that were rated by site investigators as having a possible, probable, or definite relationship to study medication.

^∥PVR volume was measured at 3, 9 months or early termination among women taking at least one dose of study medication. PVR data was unavailable for 20 participants (17 refused, and 3 were lost to follow-up).