Table 1.
Participant demographics and baseline characteristics (safety analysis set).
| Characteristic | PEAR-004 (n=55) | Sham (n=55) | Total (N=110) | |
| Age (years) | ||||
|
|
Value, mean (SD) | 43.7 (10.99) | 45.7 (11.60) | 44.7 (11.29) |
|
|
Value, median (range) | 44.0 (24-64) | 48.0 (22-65) | 45.5 (22-65) |
| Sex, n (%) | ||||
|
|
Male | 36 (65.5) | 36 (65.5) | 72 (65.5) |
|
|
Female | 19 (34.5) | 19 (34.5) | 38 (34.5) |
| Race, n (%) | ||||
|
|
American Indian or Alaska Native | 3 (5.5) | 0 (0) | 3 (2.7) |
|
|
Asian | 3 (5.5) | 4 (7.3) | 7 (6.4) |
|
|
Black or African American | 28 (50.9) | 25 (45.5) | 53 (48.2) |
|
|
Native Hawaiian or Other Pacific Islander | 0 (0) | 1 (1.8) | 1 (0.9) |
|
|
White | 18 (32.7) | 25 (45.5) | 43 (39.1) |
|
|
Other | 3 (5.5) | 0 (0) | 3 (2.7) |
| Total PANSSa score at baseline | ||||
|
|
Value, mean (SD) | 73.5 (10.25) | 72.7 (10.10) | 73.1 (10.14) |
|
|
Value, median (range) | 72.0 (61-104) | 71.0 (59-106) | 72.0 (59-106) |
| CGIb severity at baseline, n (%) | ||||
|
|
3 | 11 (20) | 11 (20) | 22 (20) |
|
|
4 | 39 (70.9) | 37 (67.3) | 76 (69.1) |
|
|
5 | 4 (7.3) | 7 (12.7) | 11 (10) |
|
|
Missing | 1 (1.8) | 0 (0) | 1 (0.9) |
| Disease duration at baseline (years) | ||||
|
|
Value, mean (SD) | 16.2 (11.40) | 18.2 (11.56) | 17.2 (11.47) |
|
|
Value, median (range) | 13.0 (1-46) | 16.0 (1-47) | 14.0 (1-47) |
aPANSS: Positive and Negative Syndrome Scale.
bCGI: Clinical Global Impression.