Table 2.
Treatment-emergent adverse events (TEAEs) occurring in ≥10% of patients in any treatment group (safety population)
| Patients, n (%) | AS/OBI-821 (N=224) | Placebo (N=124) |
P value |
| Any TEAE | 220 (98.2) | 119 (96.0) | 0.29 |
| Any injection site TEAE | 173 (77.2) | 19 (15.3) | <0.0001 |
| Injection site reaction | 127 (56.7) | 11 (8.9) | <0.0001 |
| Injection site erythema | 31 (13.8) | 1 (0.8) | <0.0001 |
| Injection site pain | 24 (10.7) | 2 (1.6) | 0.0012 |
| Injection site swelling | 23 (10.3) | 1 (0.8) | 0.0003 |
| Any non-injection site TEAE | 213 (95.1) | 117 (94.4) | 0.80 |
| Nausea | 79 (35.3) | 40 (32.3) | 0.64 |
| Fatigue | 72 (32.1) | 31 (25.0) | 0.18 |
| Fever | 45 (20.1) | 8 (6.5) | 0.0005 |
| Vomiting | 43 (19.2) | 21 (16.9) | 0.67 |
| Headache | 35 (15.6) | 23 (18.5) | 0.55 |
| Diarrhea | 34 (15.2) | 11 (8.9) | 0.10 |
| Upper respiratory tract infection | 32 (14.3) | 15 (12.1) | 0.63 |
| Cough | 26 (11.6) | 23 (18.5) | 0.08 |
| Urinary tract infection | 26 (11.6) | 18 (14.5) | 0.50 |
| Constipation | 26 (11.6) | 13 (10.5) | 0.86 |
| Back pain | 25 (11.2) | 16 (12.9) | 0.73 |
| Dizziness | 25 (11.2) | 14 (11.3) | 1.00 |
| Arthralgia | 23 (10.3) | 17 (13.7) | 0.38 |
| Insomnia | 18 (8.0) | 15 (12.1) | 0.25 |
P value: by Fisher’s exact test.