Table 2.

Baseline and change from baseline to day 42 for patient-reported outcomes and iron indices (efficacy evaluable population)

Outcomes	Ferric carboxymaltose	n	Placebo	n	P valuea
Patient-reported outcomes
FIQR
Baseline, mean (SD)	82.8 (9.5)	40	83.1 (9.4)	40
Day 42, mean change from baseline (SD)	− 45.0 (29.5)	38	− 29.7 (27.0)	39	0.015
BPI, Pain Severity
Baseline, mean (SD)	6.9 (1.2)	40	7.0 (1.4)	40
Day 42, mean change from baseline (SD)	− 3.1 (2.7)	38	− 1.8 (2.1)	39	0.022
BPI, Pain Interference
Baseline, mean (SD)	8.1 (1.2)	40	7.9 (1.3)	40
Day 42, mean change from baseline (SD)	− 4.1 (3.3)	38	− 2.3 (2.6)	39	0.010
MOS Sleep scale
Baseline, mean (SD)	72.7 (13.1)	39	79.5 (12.4)	40
Day 42, mean change from baseline (SD)	− 13.6 (18.0)	37	− 9.5 (17.1)	37	0.083
Fatigue Visual Numeric Scale
Baseline, mean (SD)	9.2 (1.0)	40	9.3 (0.9)	40
Day 42, mean change from baseline (SD)	− 3.7 (3.2)	37	− 1.7 (2.2)	39	< 0.001
Iron indices
Serum ferritin, µg/l
Screening, mean (SD)	19.0 (12.4)	40	18.1 (11.6)	40
Day 42, mean change from baseline (SD)	292.5 (145.9)	39	2.0 (13.8)	38	< 0.001
Transferrin saturation, %
Screening, mean (SD)	14.6 (5.3)	40	13.6 (5.5)	40
Day 42, mean change from baseline (SD)	24.4 (11.4)	39	5.8 (15.1)	38	< 0.001
Hematology parameters
Hemoglobin, g/dl
Screening, mean (SD)	12.3 (1.2)	41	12.3 (1.2)	40
Day 42, mean change from baseline (SD)	1.2 (0.9)	40	− 0.1 (0.9)	39	NA
Hematocrit, %
Screening, mean (SD)	38.4 (3.2)	41	38.4 (3.3)	40
Day 42, mean change from baseline (SD)	3.7 (3.0)	40	− 0.8 (5.3)	39	NA

BPI brief pain inventory, FIQR Revised Fibromyalgia Impact Questionnaire, MOS Medical Outcomes Study, NA not available, SD standard deviation

^aTreatment group differences were assessed using analysis of covariance with a fixed factor for treatment and baseline value as a covariate