Table 5. Local and systemic Adverse Events in Group 1 and Group 2.
Sign or Symptom | Group 1 N = 6 CSP+AMA1 low dose | Group 2 N = 6 CSP+AMA1 high dose | ||
All | Gr 3 | All | Gr 3 | |
LOCAL | ||||
Pain/Tenderness | 5 (83) | 0 | 5(83) | 0 |
Erythema | 0 | 0 | 0 | 0 |
Induration/Swelling | 0 | 0 | 1(17) | 0 |
Warmth | 0 | 0 | 1(17) | 0 |
Hives | 0 | 0 | 0 | 0 |
Lymphadenopathy | 2(33)* | 0 | 0 | 0 |
Limited arm motion | 1(17)* | 0 | 0 | 0 |
MEAN† LOCAL | 1.3 | 1.2 | ||
SYSTEMIC | ||||
Headache | 2(33) | 0 | 3(50) | 1(17) |
Malaise | 1(17) | 0 | 4(67) | 0 |
Fever (objective) | 0 | 0 | 2(33)‡ | 0 |
Fever (subjective) | 1 (17) | 0 | 2(33) | 0 |
Chills | 0 | 0 | 4(67) | 1(17) § |
Myalgia | 2(33) | 0 | 2(33) | 1(17) |
Arthralgia | 1(17) | 0 | 1(17) | 0 |
Nausea/vomiting | 2(33) | 0 | 3(50) | 0 |
Diarrhea | 0 | 0 | 1(17) | 0 |
Blurred vision | 0 | 0 | 1(17) | 0 |
Dizziness | 0 | 0 | 1(17) | 0 |
MEAN† SYSTEMIC | 1.5 | 4.0 | 0.5 |
Gr = severity grade.
*ipsilateral axillary tenderness.