Table 2.
Overview of treatment-emergent adverse events
| Description | YLB113 50 mg n (%) | RP 50 mg n (%) | Total n (%) |
|---|---|---|---|
| Number of subjects in Stage A with: | (N = 264) | (N = 260) | (N = 524) |
| ≥ 1 TEAEs | 146 (55.3) | 170 (65.4) | 316 (60.3) |
| ≥ 1 TEAEs related to the study drug | 58 (22.0) | 93 (35.8) | 151 (28.8) |
| ≥ 1 serious TEAEs | 8 (3.0) | 4 (1.5) | 12 (2.3) |
| ≥ 1 nonserious TEAEs | 144 (54.5) | 169 (65.0) | 313 (59.7) |
| ≥ 1 serious TEAEs related to the study drug | 4 (1.5) | 1 (0.4) | 5 (1.0) |
| A TEAE leading to study drug discontinuation | 2 (0.8) | 5 (1.9) | 7 (1.3) |
| A TEAE leading to death | 0 | 0 | 0 |
| Number of subjects in Stage B with: | (N = 236) | (N = 235) | (N = 471) |
| ≥ 1 TEAEs | 124 (52.5) | 146 (62.1) | 270 (57.3) |
| ≥ 1 TEAEs related to the study drug | 28 (11.9) | 62 (26.4) | 90 (19.1) |
| ≥ 1 serious TEAEs | 8 (3.4) | 5 (2.1) | 13 (2.8) |
| ≥ 1 nonserious TEAEs | 120 (50.8) | 144 (61.3) | 264 (56.1) |
| ≥ 1 serious TEAEs related to the study drug | 4 (1.7) | 1 (0.4) | 5 (1.1) |
| A TEAE leading to study drug discontinuation | 4 (1.7) | 4 (1.7) | 8 (1.7) |
| A TEAE leading to death | 0 | 0 | 0 |
| Number of subjects in Stage C with: | (N = 10) | (N = 8) | (N = 18) |
| ≥ 1 TEAEs | 3 (30.0) | 3 (37.5) | 6 (33.3) |
| ≥ 1 TEAEs related to the study drug | 1 (10.0) | 2 (25.0) | 3 (16.7) |
| ≥ 1 serious TEAEs | 0 | 0 | 0 |
| ≥ 1 nonserious TEAEs | 3 (30.0) | 3 (37.5) | 6 (33.3) |
| ≥ 1 serious TEAEs related to the study drug | 0 | 0 | 0 |
| A TEAE leading to study drug discontinuation | 0 | 0 | 0 |
| A TEAE leading to death | 0 | 0 | 0 |
% indicates percentage of subjects calculated relative to the total number of subjects in each column
N number of subjects in the analysis set for each column, RP etanercept reference product, TEAE treatment-emergent adverse event, total all subjects assigned to the population set