Table 2.
Notable Adverse Events through 7 days post last dose of study drug
| Category | Preferred Term | Inositol Dose group (mg/kg/day) | P-values | ||||
|---|---|---|---|---|---|---|---|
| 0 (N=35) | 10 (N=29) | 40 (N=30) | 80 (N=28) | INS vsa. Placebo | Across Dosesb | ||
| Any | Any | 33 (94%) | 25 (86%) | 27 (90%) | 24 (86%) | 0.34 | 0.65 |
| Cardiopulmonary | Poor perfusion or hypotension | 10 (29%) | 7 (24%) | 5 (17%) | 7 (25%) | 0.48 | 0.74 |
| Gastrointestinal | Elevated liver enzymes | 1 (3%) | 4 (14%) | 1 (3%) | 1 (4%) | 0.67 | 0.33 |
| Hematologic | Anemia | 16 (46%) | 8 (28%) | 14 (47%) | 11 (39%) | 0.54 | 0.42 |
| Neutropenia | 3 (9%) | 6 (21%) | 3 (10%) | 4 (14%) | 0.55 | 0.52 | |
| Thrombocytopenia | 3 (9%) | 7 (24%) | 5 (17%) | 3 (11%) | 0.27 | 0.34 | |
| Thrombocytosis | 8(23%) | 10 (34%) | 4 (13%) | 6 (21%) | 1.00 | 0.31 | |
| Metabolic | Hyperglycemia | 8 (23%) | 4 (14%) | 4 (13%) | 3 (11%) | 0.18 | 0.63 |
| Other | 7 (20%) | 5 (17%) | 4 (13%) | 2 (7%) | 0.40 | 0.53 | |
| Renal | Proteinuria | 3 (9%) | 0 (0%) | 0 (0%) | 1 (4%) | 0.07 | 0.21 |
| Oliguria | 6 (17%) | 7 (24%) | 4 (13%) | 4 (14%) | 1.00 | 0.72 | |
| Respiratory | Apnea | 11 (31%) | 6 (21%) | 10 (33%) | 13 (46%) | 1.00 | 0.23 |
a, b
P-values calculated by testing the null hypothesis of equality between aplacebo and all active doses combined, and bseparately across all 4 treatment groups using Fisher’s exact tests.