Table 2

Common treatment-related adverse events (incidence ≥5% in either arm)

System organ class/preferred termNY-ESO-1/ISCOMATRIX
participants
(n=56)
n (%)
ISCOMATRIX
participants
(n=54)
n (%)
Blood and lymphatic system disorders
 Lymphadenopathy4 (7.1)2 (3.7)
Gastrointestinal disorders
 Nausea9 (16.1)7 (13.0)
General disorders and administration site conditions
 Chest pain3 (5.4)1 (1.9)
 Chills6 (10.7)1 (1.9)
 Fatigue13 (23.2)16 (29.6)
 Influenza like illness26 (46.4)9 (16.7)
 Injection site discomfort5 (8.9)1 (1.9)
 Injection site erythema9 (16.1)1 (1.9)
 Injection site pain28 (50.0)17 (31.5)
 Injection site reaction16 (28.6)11 (20.4)
 Lethargy5 (8.9)3 (5.6)
 Malaise3 (5.4)0 (0.0)
 Fever6 (10.7)2 (3.7)
Musculoskeletal and connective tissue disorders
 Arthralgia8 (14.3)6 (11.1)
 Back pain6 (10.7)5 (9.3)
 Musculoskeletal pain3 (5.4)3 (5.6)
 Pain in extremity9 (16.1)6 (11.1)
Nervous system disorders
 Headache18 (32.1)13 (24.1)
Respiratory, thoracic and mediastinal disorders
 Cough11 (19.6)3 5.6)
 Nasopharyngitis4 (7.1)2 (3.7)
 Pharyngolaryngeal pain3 (5.4)4 (7.4)
Skin and subcutaneous tissue disorders
 Rash4 (7.1)5 (9.3)
Surgical and medical procedures
 Mass excision6 (10.7)3 (5.6)