Change of fatigue and laboratory parameters 6 weeks after treatment initiation with intravenous iron or intravenous placebo
| . | Iron group . | Placebo group . | P . |
|---|---|---|---|
| Change in fatigue (BFI) | |||
| n = 90, ITT all patients randomized | −1.1 (−2.2, −0.3) | −0.7 (−1.3, 0.0) | .07 |
| n = 86, ITT according to protocol* | −1.1 (−2.2, −0.4) | −0.8 (−1.4, 0.0) | .08 |
| Fatigue improved(SPI), n (%) | 28/43 (65%) | 19/47 (40%) | .02 |
| Fatigue slightly better | 12 (28%) | 9 (19%) | |
| Fatigue much better | 12 (28%) | 6 (13%) | |
| Fatigue completely resolved | 4 (9%) | 4 (8%) | |
| Change in laboratory parameters | |||
| Serum ferritin concentration, ng/mL | 98 (74, 113) | 1 (−7, 5) | < .001 |
| Transferrin saturation, % | 9 (0, 23) | 2 (−5, 9) | .006 |
| Haemoglobin, g/L | 1 ± 7 | 0 ± 6 | ns |
| C-reactive protein, mg/L | 0 (0, 0) | 0 (0, 0) | ns |
| . | Iron group . | Placebo group . | P . |
|---|---|---|---|
| Change in fatigue (BFI) | |||
| n = 90, ITT all patients randomized | −1.1 (−2.2, −0.3) | −0.7 (−1.3, 0.0) | .07 |
| n = 86, ITT according to protocol* | −1.1 (−2.2, −0.4) | −0.8 (−1.4, 0.0) | .08 |
| Fatigue improved(SPI), n (%) | 28/43 (65%) | 19/47 (40%) | .02 |
| Fatigue slightly better | 12 (28%) | 9 (19%) | |
| Fatigue much better | 12 (28%) | 6 (13%) | |
| Fatigue completely resolved | 4 (9%) | 4 (8%) | |
| Change in laboratory parameters | |||
| Serum ferritin concentration, ng/mL | 98 (74, 113) | 1 (−7, 5) | < .001 |
| Transferrin saturation, % | 9 (0, 23) | 2 (−5, 9) | .006 |
| Haemoglobin, g/L | 1 ± 7 | 0 ± 6 | ns |
| C-reactive protein, mg/L | 0 (0, 0) | 0 (0, 0) | ns |
Results are presented as means ± 1 SD, median values (quartiles Q1, Q3), or number of patients (%). P values were calculated with the t test, the Mann Whitney U test, or the χ2 test.
ns indicates not significant and no trend (P > .10); and ITT, intention-to-treat analysis.
Analysis included all patients treated at least once and with at least 1 postbaseline evaluation.