Table 3. Change from Baseline to Endpoint in Different Laboratory Parameters (Safety Analysis Set).
| PLACEBO (N = 64) | PALIPERIDONE ER 1.5 mg (N = 66) | PALIPERIDONE ER 6 mg (N = 70) | |
|---|---|---|---|
| Glucose (mmol/L), Mean (SD) | |||
| n | 56 | 55 | 60 |
| Change from baseline | −0.0 (1.21) | 0.1 (0.98) | 0.1 (3.81) |
| Glucose | |||
| n | 44 | 37 | 43 |
| Change from normal to higha | |||
| (<100 mg/dL to ≥126 mg/dL), n (%) | 2 (4.5%) | 2 (5.4%) | 3 (7.0%) |
| Prolactin, (ng/ml), Mean (SD) | |||
| n | 54 | 52 | 60 |
| Change from baseline | −0.1 (10.89) | 18.6 (37.47) | 51.4 (65.60) |
| Prolactin, (ng/ml) in men, Mean (SD) | |||
| n | 40 | 39 | 38 |
| Change from baseline | −1.1 (9.28) | 6.9 (15.04) | 22.9 (21.15) |
| Prolactin, (ng/ml) in women, Mean (SD) | |||
| n | 14 | 13 | 22 |
| Change from baseline | 3.0 (14.54) | 53.6 (59.03) | 100.6 (85.43) |
| Weight (Kg), Mean (SD) | |||
| n | 56 | 58 | 64 |
| Change from baseline | 0.6 (3.09) | 2.7 (18.27) | 0.5 (2.75) |
| Weight Decrease ≥ 7%, n (%) | 2 (4) | 0 (0) | 4 (6) |
| Weight Increase ≥ 7%, n (%) | 3 (5) | 4 (7) | 2 (3) |
a
change from baseline to the maximum post-baseline value.