Table 5. Safety- Adverse Events (AEs) of Rintatolimod (PolyI:C12U).
Rintatolimod (n = 117) | Placebo (n = 117) | |||
A. Stage 1: AEs During 40 Weeks of Drug Exposure | Number of Patients | % of Patients | Number of Patients | % of Patients |
Patients with ≥1 AE | 116 | 99.1 | 113 | 96.6 |
All AEs with p≤0.05 | ||||
Flu-like syndrome | 62 | 53.0 | 46 | 39.3 |
Chills | 26 | 22.2 | 11 | 9.4 |
Vasodilatation | 25 | 21.0 | 11 | 9.4 |
Dyspnea | 14 | 12.0 | 4 | 3.4 |
Patients with ≥1 Serious AE | 12 | 10 | 6 | 5 |