Table 1.
Patient demographics and baseline characteristics
| Variablea |
Ferric carboxymaltose (n = 59) |
Placebo (n = 51) |
|---|---|---|
| Age, years | 53.0 (15.7) | 55.5 (15.9) |
| Age category, n (%) | ||
| <65 years | 41 (69.5) | 35 (68.6) |
| 65‐74 years | 15 (25.4) | 11 (21.6) |
| 75‐84 years | 3 (5.1) | 5 (9.8) |
| Female, n (%) | 48 (81.4) | 42 (82.4) |
| Weight, kg | 73.88 (16.58) | 73.89 (13.10) |
| Height, cm | 166.1 (8.64) | 167.0 (7.71) |
| BMI, kg/m2 | 26.77 (5.70) | 26.46 (4.09) |
| Previous dopaminergic treatment, n (%) | 31 (53.4) | 23 (44.2) |
| Serum ferritin, μg/L | 41.93 (34.55) | 48.85 (45.95) |
| TSAT, % | 18.49 (7.88) | 21.14 (9.19) |
| IRLS total score | 25.9 (5.65) | 26.0 (5.78) |
| CGI‐Item 1 severity score | 4.8 (0.87) | 4.7 (0.74) |
| RLS‐6 | ||
| Sleep satisfaction | 7.2 (2.53) | 7.2 (2.52) |
| Severity when falling asleep | 6.8 (2.66) | 6.2 (3.03) |
| Severity during the night | 5.9 (3.06) | 5.7 (3.18) |
| Severity during the day, at rest | 4.5 (3.06) | 4.3 (2.88) |
| Severity during the day, active | 1.8 (2.30) | 2.5 (2.69) |
| Daytime tiredness | 5.9 (2.60) | 5.6 (3.07) |
a
Mean (standard deviation) unless otherwise stated.
BMI, body mass index; CGI, Clinical Global Impressions; IRLS, International Restless Legs Scale; RLS‐6, Restless Legs Syndrome‐6; TSAT, transferrin saturation.