Table 3.
Number (%) of patients with TG1050-related adverse events (AE) in SD cohort.
Place N=3 |
109 vp N=3 |
1010 vp N=3 |
1011 vp N=3 |
Overall N=12 |
||||||
---|---|---|---|---|---|---|---|---|---|---|
MedDRA Preferred Term | N (%) | Ev | N (%) | Ev | N (%) | Ev | N (%) | Ev | N (%) | Ev |
OVERALL | 1 (33.3%) | 2 | 0 (0.0%) | 0 | 1 (33.3%) | 2 | 3 (100.0%) | 8 | 5 (41.7%) | 12 |
Injection site reactions | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 1 (33.3%) | 2 | 3* (100.0%) | 5 | 4 (33.3%) | 7 |
Influenza like illness | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 1 (33.3%) | 1 | 1 (8.3%) | 1 |
Pain | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 1 (33.3%) | 1 | 1 (8.3%) | 1 |
Pyrexia | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 1 (33.3%) | 1 | 1 (8.3%) | 1 |
Dizziness | 1 (33.3%) | 1 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 1 (8.3%) | 1 |
Somnolence | 1 (33.3%) | 1 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 1 (8.3%) | 1 |
All AE were grade 1 except 1 of grade 2 (indicated by an Asterix)