TABLE 2.
Adverse effects reported by AG-702 recipients or noted by clinicians
| System | Sign or symptom | No. of subjects (% of total) receiving peptide or vaccine at the dose level shown (total subjects/group)
|
||||
|---|---|---|---|---|---|---|
| 4 μg peptide (n = 9) | 10 μg AG-702 (n = 10) | 100 μg AG-702 (n = 21) | 250 μg AG-702 (n = 22) | Total (n = 62) | ||
| Blood and lymphatic | Lymphadenopathy | 1 (11.1) | 0 (0.0) | 1 (4.8) | 3 (13.6) | 5 (8.1) |
| Gastrointestinal | Nausea | 0 (0.0) | 0 (0.0) | 3 (14.3) | 1 (4.5) | 4 (6.5) |
| General and administration site | Injection site induration | 9 (100.0) | 10 (100.0) | 21 (100.0) | 22 (100.0) | 62 (100) |
| Injection site erythema | 8 (88.9) | 9 (90.0) | 21 (100.0) | 22 (100.0) | 60 (96.8) | |
| Injection site tenderness | 0 (0.0) | 3 (30.0) | 19 (90.5) | 13 (59.1) | 35 (56.5) | |
| Injection site warmth | 0 (0.0) | 3 (30.0) | 13 (61.9) | 8 (36.4) | 24 (38.7) | |
| Injection site pain | 0 (0.0) | 2 (20.0) | 5 (23.8) | 11 (50.0) | 18 (29.0) | |
| Injection site pruritus | 0 (0.0) | 1 (10.0) | 8 (38.1) | 2 (9.1) | 11 (17.7) | |
| Fatigue | 3 (33.3) | 3 (30.0) | 3 (14.3) | 0 (0.0) | 9 (14.5) | |
| Feeling hot | 0 (0.0) | 1 (10.0) | 1 (4.8) | 2 (9.1) | 4 (6.5) | |
| Malaise | 0 (0.0) | 1 (10.0) | 1 (4.8) | 2 (9.1) | 4 (6.5) | |
| Immune | Seasonal allergy | 0 (0.0) | 1 (10.0) | 3 (14.3) | 0 (0.0) | 4 (6.5) |
| Infections and infestations | Herpes simplex symptomatic recurrence | 1 (11.1) | 2 (20.0) | 4 (19.0) | 2 (9.1) | 9 (14.5) |
| Upper respiratory tract infection | 0 (0.0) | 1 (10.0) | 5 (23.8) | 2 (9.1) | 8 (12.9) | |
| Nasopharyngitis | 1 (11.1) | 0 (0.0) | 0 (0.0) | 4 (18.2) | 5 (8.1) | |
| Sinusitis | 0 (0.0) | 1 (10.0) | 2 (9.5) | 2 (9.1) | 5 (8.1) | |
| Musculoskeletal and | Myalgia | 1 (11.1) | 3 (30.0) | 3 (14.3) | 4 (18.2) | 11 (17.7) |
| connective tissue | Back pain | 2 (22.2) | 1 (10.0) | 2 (9.5) | 3 (13.6) | 8 (12.9) |
| Nervous system | Headache | 5 (55.6) | 6 (60.0) | 9 (42.9) | 6 (27.3) | 26 (41.9) |
| Dizziness | 1 (11.1) | 0 (0.0) | 3 (14.3) | 0 (0.0) | 4 (6.5) | |
| Tension headache | 0 (0.0) | 1 (10.0) | 3 (14.3) | 0 (0.0) | 4 (6.5) | |
| Respiratory, thoracic, and | Nasal congestion | 0 (0.0) | 3 (30.0) | 4 (19.0) | 2 (9.1) | 9 (14.5) |
| mediastinal | Cough | 0 (0.0) | 3 (30.0) | 2 (9.5) | 2 (9.1) | 7 (11.3) |
| Pharyngolaryngeal pain | 1 (11.1) | 1 (10.0) | 3 (14.3) | 1 (4.5) | 6 (9.7) | |