Table 2.
Summary of Solicited Adverse Events, Maximum Intensity After Any Injection.
| Solicited Adverse Events - Locala | Solicited adverse event | Group 1 (N = 10) n (%) | Group 2 (N = 10) n (%) | Group 3 (N = 10) n (%) | All participants (Nb = 30) n (%) |
|---|---|---|---|---|---|
|
| |||||
| Any local symptom | None | 5 (50%) | 4 (40%) | 8 (80%) | 17 (56.7%) |
| Mild | 5 (50%) | 6 (60%) | 2 (20%) | 13 (43.3%) | |
| Moderate | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Pain at injection site | None | 9 (90%) | 7 (70%) | 9 (90%) | 25 (83.3%) |
| Mild | 1 (10%) | 3 (30%) | 1 (10%) | 5 (16.7%) | |
| Moderate | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Tenderness at injection site | None | 6 (60%) | 4 (40%) | 9 (90%) | 19 (63.3%) |
| Mild | 4 (40%) | 6 (60%) | 1 (10%) | 11 (36.7%) | |
| Moderate | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Swelling at injection site | None | 10 (100%) | 8 (80%) | 9 (90%) | 27 (90%) |
| Mild | 0 (0%) | 2 (20%) | 1 (10%) | 3 (10%) | |
| Moderate | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Erythema/Redness measurement | None | 10 (100%) | 9 (90%) | 10 (100%) | 29 (96.7%) |
| Mild | 0 (0%) | 1 (10%) | 0 (0%) | 1 (3.3%) | |
| Moderate | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Induration/Swelling measurement | None | 10 (100%) | 10 (100%) | 10 (100%) | 30 (100%) |
| Mild | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Moderate | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
|
| |||||
| Solicited Adverse Events - Systemica | Solicited adverse event | Group 1 (N = 10) n (%) | Group 2 (N = 10) n (%) | Group 3 (N = 10) n (%) | All participants (Nb = 30) n (%) |
|
| |||||
| Any systemic symptom | None | 9 (90%) | 9 (90%) | 6 (60%) | 24 (80%) |
| Mild | 0 (0%) | 1 (10%) | 2 (20%) | 3 (10%) | |
| Moderate | 0 (0%) | 0 (0%) | 1 (10%) | 1 (3.3%) | |
| Severe | 1 (10%) | 0 (0%) | 1 (10%) | 2 (6.7%) | |
| Arthralgia | None | 10 (100%) | 10 (100%) | 9 (90%) | 29 (96.7%) |
| Mild | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Moderate | 0 (0%) | 0 (0%) | 1 (10%) | 1 (3.3%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Chills | None | 10 (100%) | 10 (100%) | 9 (90%) | 29 (96.7%) |
| Mild | 0 (0%) | 0 (0%) | 1 (10%) | 1 (3.3%) | |
| Moderate | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Fatigue | None | 9 (90%) | 9 (90%) | 7 (70%) | 25 (83.3%) |
| Mild | 0 (0%) | 1 (10%) | 3 (30%) | 4 (13.3%) | |
| Moderate | 1 (10%) | 0 (0%) | 0 (0%) | 1 (3.3%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Headache | None | 9 (90%) | 9 (90%) | 9 (90%) | 27 (90%) |
| Mild | 0 (0%) | 1 (10%) | 0 (0%) | 1 (3.3%) | |
| Moderate | 1 (10%) | 0 (0%) | 1 (10%) | 2 (6.7%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Malaise | None | 9 (90%) | 9 (90%) | 8 (80%) | 26 (86.7%) |
| Mild | 0 (0%) | 1 (10%) | 2 (20%) | 3 (10%) | |
| Moderate | 1 (10%) | 0 (0%) | 0 (0%) | 1 (3.3%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Myalgia | None | 10 (100%) | 9 (90%) | 9 (90%) | 28 (93.3%) |
| Mild | 0 (0%) | 1 (10%) | 1 (10%) | 2 (6.7%) | |
| Moderate | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Nausea | None | 9 (90%) | 10 (100%) | 8 (80%) | 27 (90%) |
| Mild | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Moderate | 1 (10%) | 0 (0%) | 1 (10%) | 2 (6.7%) | |
| Severe | 0 (0%) | 0 (0%) | 1 (10%) | 1 (3.3%) | |
| Vomiting | None | 9 (90%) | 10 (100%) | 9 (90%) | 28 (93.3%) |
| Mild | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Moderate | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Severe | 1 (10%) | 0 (0%) | 1 (10%) | 2 (6.7%) | |
| Dizziness | None | 10 (100%) | 10 (100%) | 9 (90%) | 29 (96.7%) |
| Mild | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Moderate | 0 (0%) | 0 (0%) | 1 (10%) | 1 (3.3%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Fever | None | 10 (100%) | 10 (100%) | 10 (100%) | 30 (100%) |
| Mild | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Moderate | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
a
Participants are counted once at the highest severity reported.
b
N = all enrolled participants