Table 1.
Number of subjects experiencing solicited adverse events by treatment group.
| 105 SCAR (N=10) |
107 SCAR (N=10) |
109 SCAR (N=10) |
102 SQ (N=10) |
103 SQ (N=10) |
104 SQ (N=10) |
105 SQ (N=10) |
Placebo (N=14) |
|
|---|---|---|---|---|---|---|---|---|
| Systemic | ||||||||
| Fever | ||||||||
| Any | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 1 |
| Grade ≥2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Feverishness | ||||||||
| Any | 2 | 3 | 1 | 3 | 3 | 2 | 4 | 3 |
| Grade ≥2 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 |
| Myalgia | ||||||||
| Any | 1 | 6 | 2 | 3 | 4 | 4 | 6 | 4 |
| Grade ≥2 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 |
| Chills | ||||||||
| Any | 1 | 2 | 2 | 1 | 2 | 0 | 2 | 2 |
| Grade ≥2 | 0 | 2 | 1 | 0 | 1 | 0 | 0 | 1 |
| Headaches | ||||||||
| Any | 4 | 7 | 4 | 7 | 5 | 6 | 6 | 10 |
| Grade ≥2 | 2 | 2 | 2 | 4 | 2 | 3 | 1 | 5 |
| Nausea | ||||||||
| Any | 0 | 2 | 0 | 2 | 3 | 3 | 4 | 1 |
| Grade ≥2 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 |
| Fatigue | ||||||||
| Any | 4 | 4 | 6 | 5 | 7 | 7 | 8 | 9 |
| Grade ≥2 | 0 | 2 | 6 | 1 | 2 | 4 | 3 | 3 |
| Axillary pain | ||||||||
| Any | 0 | 0 | 1 | 0 | 1 | 2 | 1 | 0 |
| Grade ≥2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Axillary swelling | ||||||||
| Any | 0 | 0 | 1 | 1 | 0 | 1 | 2 | 0 |
| Grade ≥2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Joint pain | ||||||||
| Any | 0 | 1 | 2 | 1 | 0 | 2 | 5 | 0 |
| Grade ≥2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Rash | ||||||||
| Any | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 |
| Grade ≥2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Local | ||||||||
| Pain/tenderness | ||||||||
| Any | 6 | 3 | 6 | 1 | 2 | 10 | 9 | 2 |
| Grade ≥2 | 0 | 0 | 2 | 0 | 0 | 1 | 2 | 0 |
| Itching | ||||||||
| Any | 5 | 5 | 7 | 0 | 1 | 3 | 5 | 1 |
| Grade ≥2 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 |
| Erythema | ||||||||
| Any | 10 | 10 | 10 | 8 | 6 | 9 | 10 | 9 |
| Grade ≥2 | 1 | 1 | 10 | 0 | 0 | 4 | 8 | 1 |
| Induration/Swelling | ||||||||
| Any | 10 | 10 | 10 | 6 | 4 | 9 | 10 | 7 |
| Grade ≥2 | 0 | 1 | 9 | 0 | 0 | 8 | 9 | 0 |
Notes. For erythema and induration: we used the maximum reported diameter on the diary card or during the in-clinic examination.