Table 2.
TEAEs and SAEs during the 24-week treatment period (TP1 safety set)
| Preferred term | GP2015 (n=186) n (%) |
ETN (n=190) n (%) |
| ≥1 TEAE | 81 (43.5) | 94 (49.5) |
| ≥1 SAE | 1 (0.5) | 5 (2.6) |
| ≥1 Treatment-related TEAE | 39 (21.0) | 46 (24.2) |
| ≥1 Treatment-related SAE | 0 | 0 |
| Discontinuations due to TEAE | 2 (1.1) | 7 (3.7) |
| ≥1 AE of special interest | 12 (6.5) | 9 (4.7) |
| Deaths | 0 | 1 (0.5) |
| TEAEs with a ≥2% incidence in any of the treatment groups | ||
| Injection-site reaction | 13 (7.0) | 35 (18.4) |
| Nasopharyngitis | 9 (4.8) | 4 (2.1) |
| Alanine aminotransferase increased | 8 (4.3) | 4 (2.1) |
| Urinary tract infection | 8 (4.3) | 8 (4.2) |
| Upper respiratory tract infection | 6 (3.2) | 7 (3.7) |
| Back pain | 5 (2.7) | 1 (0.5) |
| Diarrhoea | 3 (1.6) | 4 (2.1) |
| Bronchitis | 2 (1.1) | 4 (2.1) |
| Cystitis | 2 (1.1) | 4 (2.1) |
A patient with multiple occurrences of event within the same system organ class or preferred term under one treatment is counted only once. TEAEs are events started after the first dose of study treatment and before study discontinuation or 30 days after the last dose, whichever occurs later. Adverse event terms are coded using MedDRA V.19.1.
ETN, reference etanercept; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TP1, treatment period 1.