Table 1 Baseline demographics
ITT analysis set (all randomized) | ≥ 90% methylation group | < 90% methylation group | |||||||
|---|---|---|---|---|---|---|---|---|---|
Placebo (n = 102) | ZYN002 (n = 110) | Total (N = 212) | Placebo (n = 77) | ZYN002 (n = 92) | Total (n = 169) | Placebo (n = 25) | ZYN002 (n = 17) | Total (n = 42) | |
Age (years) | |||||||||
Mean | 9.8 | 9.6 | 9.7 | 9.6 | 9.2 | 9.4 | 10.4 | 12.1 | 11.1 |
Median (min, max) | 10.0 (3, 17) | 9.0 (3, 17) | 10.0 (3, 17) | 9.0 (3, 17) | 9.0 (3, 17) | 9.0 (3, 17) | 11.0 (5, 16) | 12.0 (5, 17) | 11.0 (5, 17) |
Sex—males, n (%) | 78 (76.5) | 81 (73.6) | 159 (75.0) | 54 (70.1) | 65 (70.7) | 119 (70.4) | 24 (96.0) | 15 (88.2) | 39 (92.9) |
Weight (kg) | |||||||||
Median (min, max) | 34.3 (15.6, 104.7) | 36.8 (14.6, 87.0) | 35.7 (14.6, 104.7) | 33.9 (15.6, 104.7) | 35.7 (14.6, 87.0) | 35.0 (14.6, 104.7) | 40.3 (21.9, 79.3) | 50.0 (21.4, 66.4) | 41.5 (21.4, 79.3) |
Weight category | |||||||||
> 35 kg, n (%) | 49 (48.0) | 61 (55.5) | 110 (51.9) | 35 (45.5) | 49 (53.3) | 84 (49.7) | 14 (56.0) | 12 (70.6) | 26 (61.9) |
ADOS®-2 | |||||||||
Comparison scorea | |||||||||
Median (min, max) | 7.0 (1, 10) | 7.0 (1, 10) | 7.0 (1, 10) | 8.0 (1, 10) | 7.0 (1, 10) | 7.0 (1, 10) | 6.0 (1, 10) | 7.0 (3, 10) | 7.0 (1, 10) |
Comparison score | |||||||||
Categories,a n (%) | |||||||||
Minimal/no evidence | 9 (9.1) | 9 (8.4) | 18 (8.7) | 6 (7.9) | 9 (10.0) | 15 (9.0) | 3 (13.0) | 0 | 3 (7.7) |
Mild | 11 (11.1) | 11 (10.3) | 22 (10.7) | 9 (11.8) | 10 (11.1) | 19 (11.4) | 2 (8.7) | 1 (6.3) | 3 (7.7) |
Moderate | 29 (29.3) | 37 (34.6) | 66 (32.0) | 19 (25.0) | 30 (33.3) | 49 (29.5) | 10 (43.5) | 6 (37.5) | 16 (41.0) |
Severe | 45 (45.5) | 47 (43.9) | 92 (44.7) | 37 (48.7) | 41 (45.6) | 78 (47.0) | 8 (34.8) | 6 (37.5) | 14 (35.9) |
Not applicable | 5 (5.1) | 3 (2.8) | 8 (3.9) | 5 (6.6) | 0 | 5 (3.0) | 0 | 3 (18.8) | 3 (7.7) |
Missing | 3 | 3 | 6 | 1 | 2 | 3 | 2 | 1 | 3 |
VABS-3 | |||||||||
Overall—adaptive behavior composite scores | |||||||||
n | 100 | 102 | 202 | 76 | 84 | 160 | 24 | 17 | 41 |
Median (min, max) | 53.5 (25, 93) | 51.1 (23, 119) | 52.0 (23, 119) | 51.5 (24, 119) | 51.5 (24, 119) | 51.5 (24, 119) | 60.0 (27, 84) | 47.0 (23, 74) | 57.0 (23, 84) |