Table 2.

Treatment-related adverse events recorded in at least 1.5% in either group

Racotumomab-alum (n = 86)Placebo (n = 89)
Adverse eventAll gradesGrade III–IVAll gradesGrade III–IV
Burning in injection site36 (41.9%)0 (0%)35 (39.3%)0 (0%)
Pain in injection site29 (33.7%)0 (0%)22 (24.7%)0 (0%)
Bone pain16 (18.6%)1 (1.1%)17 (19.1%)1 (1.1%)
Cough7 (8.1%)0 (0%)11 (12.4%)0 (0%)
Dyspnea5 (5.8%)0 (0%)5 (5.6%)1 (1.2%)
Asthenia14 (16.3%)1 (1.2%)10 (11.2%)0 (0%)
Anorexia6 (7.0%)0 (0%)7 (7.9%)0 (0%)
Expectoration1 (1.2%)0 (0%)3 (3.4%)0 (0%)
Induration10 (11.6%)0 (0%)9 (10.1%)0 (0%)
Headache8 (9.3%)0 (0%)9 (10.1%)0 (0%)
Pruritus9 (10.5%)0 (0%)5 (5.6%)0 (0%)
Fever8 (9.3%)0 (0%)12 (13.5%)0 (0%)
Increased volume in injection site9 (10.5%)0 (0%)3 (3.4%)0 (0%)
Local erythema11 (12.8%)0 (0%)11 (12.4%)0 (0%)
Myalgia5 (5.8%)0 (0%)7 (7.9%)0 (0%)
Arthralgia5 (5.8%)0 (0%)5 (5.6%)0 (0%)

NOTE: Data are number of patients (%). Adverse events graded by CTCAE version 3.0.