Table 2. Patient Characteristics in the Propensity Score–Matched Sample.
Characteristic | No. (%) of patients | |||||
---|---|---|---|---|---|---|
Totala | EFASa | Non-EFASa | ||||
Edaravone (n = 130) | Matched controls (n = 130) | Edaravone (n = 52) | Matched controls (n = 52) | Edaravone (n = 78) | Matched controls (n = 78) | |
Sex | ||||||
Female | 48 (37) | 47 (36) | 19 (37) | 18 (35) | 29 (37) | 29 (37) |
Male | 82 (63) | 83 (64) | 33 (63) | 34 (65) | 49 (63) | 49 (63) |
Symptom onset | ||||||
Spinal | 97 (75) | 97 (75) | 37 (71) | 37 (71) | 60 (77) | 60 (77) |
Bulbar | 33 (25) | 33 (25) | 15 (29) | 15 (29) | 18 (23) | 18 (23) |
Age, median (IQR), y | ||||||
At disease onset | 56.1 (49.0 to 63.3) | 55.4 (48.0 to 62.3) | 55.8 (47.1 to 60.8) | 56.2 (52.1 to 62.4) | 56.2 (49.8 to 63.5) | 53.2 (47.6 to 62.6) |
At baseline | 57.5 (50.5 to 64.5) | 56.7 (49.8 to 63.8) | 57.2 (47.8 to 62.6) | 57.8 (53.5 to 63.2) | 57.7 (51.8 to 64.8) | 54.9 (48.8 to 64.8) |
Baseline, median (IQR) | ||||||
Disease duration, mo | 16.4 (10.3 to 23.0) | 15.5 (10.1 to 24.3) | 12.9 (9.97 to 18.6) | 15.1 (8.24 to 25.2) | 19.0 (11.7 to 28.1) | 16.1 (10.7 to 22.9) |
ALSFRS-R, score | 38 (32.7 to 42) | 39 (35 to 42) | 39.5 (36 to 42) | 39 (36 to 42.7) | 36 (30 to 42) | 38 (34 to 42) |
ΔFRS, median (IQR), points/mo | −0.58 (−1.07 to −0.31) | −0.52 (−1.02 to −0.32) | −0.61 (−0.97 to −0.43) | −0.54 (−1.04 to −0.29) | −0.56 (−1.30 to −0.24) | −0.52 (−0.96 to −0.35) |
Follow-up, median (IQR), mo | 12.7 (7.6 to 18.5) | 11.1 (6.4 to 19.2) | 14.9 (9.6 to 21.9) | 12.4 (6.2 to 22.2) | 10.3 (6.4 to 17.2) | 11.1 (6.4 to 18.0) |
Abbreviations: ALSFRS-R, ALS Functional Rating Scale-Revised; EFAS, potentially eligible for the MCI186-ALS19 study; ΔFRS, change in ALSFRS-R slope between disease onset and baseline; non-EFAS, ineligible for the MCI186-ALS19 study.
Data formally tested for the total population as well as the EFAS and non-EFAS subgroups, and no statistically significant differences were found between patients receiving edaravone and their matched controls.