Table IV.
TEAEs occurring in a least 5% of patients in any treatment group during period 1
| TEAE | SoC-ABX464m (n = 335) no. patients (%) no. events | SoC-placebo (N = 170) no. patients (%) no. events | Total (N = 505) no. patients (%) no. events |
|---|---|---|---|
| No. of patients with ≥1 TEAE | 115 (34.3) 161 | 27 (15.9) 41 | 142 (28.1) 202 |
| Gastrointestinal disorders | 73 (21.8) 86 | 14 (8.2) 18 | 87 (17.2) 104 |
| Abdominal pain upper | 32 (9.6) 34 | 5 (2.9) 5 | 37 (7.3) 39 |
| Diarrhea | 30 (9.0) 31 | 6 (3.5) 6 | 36 (7.1) 37 |
| Nausea | 20 (6.0) 21 | 6 (3.5) 7 | 26 (5.1) 28 |
| Nervous system disorders | 49 (14.6) 51 | 15 (8.8) 19 | 64 (12.7) 70 |
| Headache | 49 (14.6) 51 | 15 (8.8) 19 | 64 (12.7) 70 |
| Musculoskeletal and connective tissue disorders | 23 (6.9) 24 | 4 (2.4) 4 | 27 (5.3) 28 |
| Back pain | 23 (6.9) 24 | 4 (2.4) 4 | 27 (5.3) 28 |