Table 1. Baseline Demographics and Disease Characteristics.
| Variable | EMPOWER Placebo Group (n = 456) | BENEFIT-ALS Placebo Group (n = 210) | PRO-ACT Database Placebo Patients (n = 227) | Total (N = 893) |
|---|---|---|---|---|
| Age, mean (SD), y | 57.3 (11.3) | 56.8 (10.6) | 55.4 (11.6) | 56.7 (11.2) |
| Sex, No. (%) | ||||
| Male | 289 (63.4) | 148 (70.5) | 148 (65.2) | 585 (65.5) |
| Female | 167 (36.6) | 62 (29.5) | 79 (34.8) | 308 (34.5) |
| BMI, mean (SD) | 26.1 (4.3) | 26.8 (4.4) | 25.3 (4.0) | 26.1 (4.3) |
| White, No. (%) | 428 (93.9) | 175 (83.3) | 218 (96.0) | 821 (91.9) |
| Duration of symptoms, mean (SD), mo | 15.6 (5.4) | 26.7 (23.7) | 18.6 (8.3) | 19.0 (13.6) |
| Time from diagnosis to baseline, mean (SD), mo | 7.7 (5.0) | 12.2 (17.1) | 8.3 (6.9) | 8.9 (9.8) |
| Family history of ALS, No. (%) | 24 (5.3) | 12 (5.7) | ND | ND |
| Riluzole use, No. (%) | ||||
| No | 115 (25.2) | 73 (34.8) | ND | ND |
| Yes | 341 (74.8) | 137 (65.2) | ND | ND |
| Baseline SVC, mean (SD) | 89.3 (17.7) | 89.7 (17.2) | 93.5 (15.6) | 90.5 (17.1) |
| Baseline SNIP, mean (SD) | 55.0 (26.3) | 61.4 (25.7) | ND | ND |
| Site of ALS symptom onset, No. (%)a | ||||
| Bulbar | 111 (24.3) | 30 (14.3) | 42 (18.5) | 183 (20.5) |
| Other | 345 (75.7) | 180 (85.7) | 187 (82.4) | 712 (79.7) |
| Baseline ALSFRS-R total score, mean (SD) | 38.0 (5.6) | 37.3 (4.2) | ND | ND |
Abbreviations: ALS, amyotrophic lateral sclerosis; ALSFRS-R, Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); ND, no data; SNIP, sniff nasal inspiratory pressure; SVC, slow vital capacity.
a
Two patients in the PRO-ACT database reported both bulbar and other for site of ALS symptom onset.