Corrections to: Once-daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study

Figures & data

Table 5. Summary of treatment-emergent AEs (single-blind analysis set and full analysis set – all causality).

Summary of AEs	Single-blind analysis set	Double-blind full analysis set
	Pregabalin CR (n = 441), n (%)	Pregabalin CR (n = 63), n (%)	Placebo^a (n = 58), n (%)
All AEs	353 (80.0)	34 (54.0)	27 (46.6)
Serious AE	5 (1.1)	2 (3.2)	0 (0.0)
Severe AE	28 (6.3)	5 (7.9)	0 (0.0)
Discontinuation owing to AE	54 (12.2)	3 (4.8)	0 (0.0)
Dose reduced or temporary discontinuation owing to AE	45 (10.2)	1 (1.6)	0 (0.0)
All AEs occurring in ≥5% of patients in any treatment group
Preferred term^b
Dizziness	161 (36.5)	2 (3.2)	2 (3.4)
Somnolence	105 (23.8)	0 (0.0)	0 (0.0)
Headache	43 (9.8)	1 (1.6)	2 (3.4)
Fatigue	42 (9.5)	1 (1.6)	0 (0.0)
Nausea	41 (9.3)	5 (7.9)	0 (0.0)
Weight increase	30 (6.8)	2 (3.2)	1 (1.7)
Vision blurred	29 (6.6)	1 (1.6)	0 (0.0)
Peripheral edema	27 (6.1)	6 (9.5)	2 (3.4)
Dry mouth	25 (5.7)	0 (0.0)	2 (3.4)
Disturbance in attention	24 (5.4)	0 (0.0)	0 (0.0)
Insomnia	24 (5.4)	3 (4.8)	1 (1.7)
Nasopharyngitis	3 (0.7)	1 (1.6)	3 (5.2)

^a Includes AEs from 1-week pregabalin taper at beginning of double-blind phase.

^b Medical Dictionary for Regulatory Activities, version 18.0 (MedDRA [v18.0]) coding dictionary applied.

Figure 4. Weekly mean pain scores taken form daily pain diaries (11-point numeric rating scale from 0 [no pain] to 10 [worst possible pain]) during the single-blind and double-blind treatment phases. Single-blind baseline (SBB; n = 441), double-blind baseline (placebo, n = 58; pregabalin controlled-release, n = 63), double-blind endpoint (DBE; placebo, n = 58; pregabalin controlled-release, n = 62). DBE represents the mean of the last 7 day diary scores during the double-blind phase, last observation carried forward. CR, controlled-release; PBO, placebo; PGB, pregabalin.

Table 2. Summary of Kaplan-Meier estimates of time to LTR by treatment group.

Treatment	N	Time to LTR (95% CI), days		p Value comparison with placebo^b	Patients with LTR by end of double-blind phase, n (%)
		First quartile^a	Median
Placebo	58	10 (9–13)	23 (14–41)		41 (70.7)
Pregabalin CR (330–495 mg)	63	20 (11–44)	58 (45–NA)	0.0186	34 (54.0)

^a One-quarter of patients lost therapeutic response by the day listed.

^b Calculated using the log-rank test.

CI, confidence interval; CR, controlled-release; LTR, loss of therapeutic response; NA, no upper limit available.