Table 3 Incidence of related adverse events by system organ class preferred term and NCI-CTCAE grade, safety population. No grade 4 or 5 adverse events observed in part 2.
System organ class | Preferred term | Treatment | Grade 1 | Grade 2 | Grade 3 | Total (n = 19) |
|---|---|---|---|---|---|---|
Cardiac disorders | Tachycardia | AdAPT-001 1 × 1012 VP | 0 (0.0) | 1 (5.3) | 0 (0.0) | 1 (5.3) |
Gastrointestinal disorders | Dry mouth | AdAPT-001 1 × 1012 VP | 1 (5.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
Nausea | AdAPT-001 1 × 1012 VP | 0 (0.0) | 1 (5.3) | 0 (0.0) | 1 (5.3) | |
Vomiting | AdAPT-001 1 × 1012 VP | 1 (5.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) | |
General disorders and administration site conditions | Asthenia | AdAPT-001 1 × 1012 VP | 1 (5.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
Chills | AdAPT-001 1 × 1012 VP | 5 (26.3) | 1 (5.3) | 0 (0.0) | 6 (31.6) | |
Fatigue | AdAPT-001 1 × 1012 VP | 1 (5.3) | 1 (5.3) | 0 (0.0) | 2 (10.5) | |
Injection related reaction | AdAPT-001 1 × 1012 VP | 5 (26.3) | 0 (0.0) | 0 (0.0) | 5 (26.3) | |
Pyrexia | AdAPT-001 1 × 1012 VP | 2 (10.5) | 1 (5.3) | 0 (0.0) | 3 (15.8) | |
Swelling face | AdAPT-001 1 × 1012 VP | 1 (5.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) | |
Infections and infestations | Sinusitis | AdAPT-001 1 × 1012 VP | 1 (5.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
Injury, poisoning, and procedural complications | Injection related reaction | AdAPT-001 1 × 1012 VP | 2 (10.5) | 1 (5.3) | 0 (0.0) | 3 (15.8) |
Investigations | Platelet count decreased | AdAPT-001 1 × 1012 VP | 1 (5.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
Musculoskeletal and connective tissue disorders | Arthralgia | AdAPT-001 1 × 1012 VP | 1 (5.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
Neck pain | AdAPT-001 1 × 1012 VP | 1 (5.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) | |
Pain in extremity | AdAPT-001 1 × 1012 VP | 1 (5.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) | |
Nervous system disorders | Dysgeusia | AdAPT-001 1 × 1012 VP | 1 (5.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
Skin and subcutaneous tissues disorders | Dermatitis acneiform | AdAPT-001 1 × 1012 VP | 0 (0.0) | 0 (0.0) | 1 (5.3) | 1 (5.3) |
Vascular disorders | Hypertension | AdAPT-001 1 × 1012 VP | 0 (0.0) | 0 (0.0) | 1 (5.3) | 1 (5.3) |