Table 3.
Overall summary of treatment-emergent adverse events (TEAE) by severity: safety set population
| All TEAEs | Placebo (group 1) (n = 31) |
GV1001 0.56 mg (group 2) (n = 32) |
GV1001 1.12 mg (group 3) (n = 32) |
Overall (n = 95) |
P value | ||||
|---|---|---|---|---|---|---|---|---|---|
| n (%) | Events | n (%) | Events | n (%) | Events | n (%) | Events | ||
| Mild | 12 (38.7) | 32 | 13 (40.6) | 33 | 10 (31.3) | 28 | 35 (36.8) | 93 | 0.714a |
| Moderate | 2 (6.5) | 4 | 5 (15.6) | 7 | 5 (15.6) | 10 | 12 (12.6) | 21 | 0.451a |
| Severe | 2 (6.5) | 2 | 0 (0.0) | 0 | 0 (0.0) | 0 | 2 (2.1) | 2 | 0.104b |
Note: study group 1 = placebo (control); study group 2 = GV1001 0.56 mg; study group 3 = GV1001 1.12 mg
Abbreviations: TEAE treatment-emergent adverse event, n number of patients
aChi-square test; bFisher’s exact test