Table 2.
Common treatment-related adverse events (incidence ≥5% in either arm)
| System organ class/preferred term | NY-ESO-1/ISCOMATRIX participants (n=56) n (%) |
ISCOMATRIX participants (n=54) n (%) |
| Blood and lymphatic system disorders | ||
| Lymphadenopathy | 4 (7.1) | 2 (3.7) |
| Gastrointestinal disorders | ||
| Nausea | 9 (16.1) | 7 (13.0) |
| General disorders and administration site conditions | ||
| Chest pain | 3 (5.4) | 1 (1.9) |
| Chills | 6 (10.7) | 1 (1.9) |
| Fatigue | 13 (23.2) | 16 (29.6) |
| Influenza like illness | 26 (46.4) | 9 (16.7) |
| Injection site discomfort | 5 (8.9) | 1 (1.9) |
| Injection site erythema | 9 (16.1) | 1 (1.9) |
| Injection site pain | 28 (50.0) | 17 (31.5) |
| Injection site reaction | 16 (28.6) | 11 (20.4) |
| Lethargy | 5 (8.9) | 3 (5.6) |
| Malaise | 3 (5.4) | 0 (0.0) |
| Fever | 6 (10.7) | 2 (3.7) |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 8 (14.3) | 6 (11.1) |
| Back pain | 6 (10.7) | 5 (9.3) |
| Musculoskeletal pain | 3 (5.4) | 3 (5.6) |
| Pain in extremity | 9 (16.1) | 6 (11.1) |
| Nervous system disorders | ||
| Headache | 18 (32.1) | 13 (24.1) |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 11 (19.6) | 3 5.6) |
| Nasopharyngitis | 4 (7.1) | 2 (3.7) |
| Pharyngolaryngeal pain | 3 (5.4) | 4 (7.4) |
| Skin and subcutaneous tissue disorders | ||
| Rash | 4 (7.1) | 5 (9.3) |
| Surgical and medical procedures | ||
| Mass excision | 6 (10.7) | 3 (5.6) |