Table 10.
Summary of all patients with adverse events with at least 5% difference between rintatolimod and placebo.
| Patients with any adverse events | Controlled portions of Phase II/III clinical trials |
||
|---|---|---|---|
| Studies AMP-502 and AMP-516 | |||
| Rintatolimod |
Placebo |
||
| (N = 162) |
(N = 164) |
||
| 161 (99.4 %) | 160 (97.6 %) | ||
| Adverse events | % Difference* | ||
| Flu-like symptoms | 13.9 | 72 (44.4 %) | 50 (30.5 %) |
| Headache | 12.8 | 74 (45.7 %) | 54 (32.9 %) |
| Chills | 9.4 | 27 (16.7 %) | 12 (7.3 %) |
| Fever | 8.2 | 33 (20.4 %) | 20 (12.2 %) |
| Vasodilatation | 7.6 | 27 (16.7 %) | 15 (9.1 %) |
| Pain | 7.3 | 75 (46.3 %) | 64 (39.0 %) |
| Injection site reaction | 7.1 | 50 (30.9 %) | 39 (23.8 %) |
| Pruritus | 7.0 | 33 (20.4 %) | 22 (13.4 %) |
| Diarrhea | 6.3 | 36 (22.2 %) | 26 (15.9 %) |
| Syncope | 6.2 | 13 (8.0 %) | 3 (1.8 %) |
| Ear disorder | 5.7 | 22 (13.6 %) | 13 (7.9 %) |
| Nausea | 5.4 | 67 (41.4 %) | 59 (36.0 %) |
| Migraine | −5.3 | 16 (9.9 %) | 25 (15.2 %) |