Table 1.

Details of included studies

Reference and NCT numbera	Study design		Active treatments	Incidence of constipationb (%)					Discontinuations due to constipationb (%)
				DAR total	7.5 mg/day	15 mg/day	PBO	TOL 4 mg/day	DAR total	7.5 mg/day	15 mg/day	PBO	TOL 4 mg/day
Fixed-dose Phase III trials included in the pooled analysis
Foote and Elhilali39	12-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group in patients aged ≥18 years		DAR 15 mg/day or 30 mg/day, TOL 4 mg/day	n/a	n/a	28/112 (24.1%)	7/115 (6.1%)	28/223 (12.6%)		0	3/112 (2.7%)	0	4/232 (1.8%)
Hill et al40	12-week, multicenter, double-blind, randomized, placebo-controlled, dose-response in patients aged ≥18 years		DAR 7.5 mg/day, 15 mg/day, 30 mg/day	n/a	17/108 (15.7%)	27/107 (25.2%)	5/109 (4.6%)	n/a	1/324 (0.3%)	0	0	0	n/a
Haab et al41	12-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group study in patients aged ≥18 years		DAR 3.75 mg/day, 7.5 mg/day, 15 mg/day	n/a	33/229 (14.4%)	16/115 (13.9%)	12/164 (7.3%)	n/a	n/a	2/229 (0.9%)	1/115 (0.9%)	1/164 (0.6%)	n/a
Reference	Study no	Study design	Active treatments	Incidence of constipationb (%)					Discontinuations due to constipationb (%)
				DAR total	7.5 mg/d	15 mg/d	PBO	TOL 4 mg/d	DAR total	7.5 mg/d	15 mg/d	PBO	TOL 4 mg/d
Phase IIIb studies
Haab et al42 170755	1	2-year, open-label, multicenter, extension study to the Phase II trials	DAR 7.5 mg/day or 15 mg/day	150/716 (20.9%)	n/a	n/a	n/a	n/a	17/716 (2.4%)	n/a	n/a	n/a	n/a
Steers et al14	2	12-week, Phase IIb flexible-dosing, multicenter, double-blind, randomized, placebo-controlled parallel-group study in patients aged ≥18 years	DAR 7.5 mg/day with optional uptitration to 15 mg/day	56/268 (20.9%)	n/a	n/a	10/127 (7.9%)	n/a	6/268 (2.2%)	n/a	n/a	1/127 (0.8%)	n/a
Zinner et al45 171145	3	12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to assess effects on warning time	DAR 15 mg/day	n/a	n/a	38/214 (17.8%)	11/225 (4.9%)	n/a	n/a	n/a	5/214 (2.3%)	0/225 (0.0%)	n/a
Phase IV studies
Zinner et al43 366002	4	12-week, open-label, single-arm, multicenter switch study in patients with OAB dissatisfied with previous treatment with oxybutynin or TOL	DAR 7.5 mg/day with optional uptitration to 15 mg/day	70/497 (14.1%)	n/a	n/a	n/a	n/a	4/497 (0.8%)	n/a	n/a	n/a	n/a
Chancellor et al44 127270	5	12-week, randomized, open-label, parallel-group, multicenter study in OAB patients	DAR 7.5 mg/day with optional uptitration to 15 mg/day, alone or in combination with a behavioral modification plan	73/395 (18.5%)	n/a	n/a	n/a	n/a	8/395 (2.0%)	n/a	n/a	n/a	n/a
Chapple et al46 171184	6	12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in patients ≥65 years of age with OAB	DAR 7.5 mg/day with optional uptitration to 15 mg/day	43/266 (16.2%)	n/a	n/a	11/133 (8.3%)	n/a	2/266 (0.8%)	n/a	n/a	1/133 (0.8%)c	n/a

Notes:

^aNCT numbers provided where applicable (studies without a number were completed prior to the registration mandate), all numbers are prefixed 00;

^bthese data reflect the two licensed darifenacin doses (7.5 mg/day and 15 mg/day);

^csafety population.

Abbreviations: DAR, darifenacin; OAB, overactive bladder; n/a, not applicable; PBO, placebo; TOL, tolterodine.