Table 2. Treatment-Emergent Adverse Events (TEAEs) and Dose Reductions, Interruptions, or Discontinuations.
| Events, No. (%)a | ||||||
|---|---|---|---|---|---|---|
| ISABELA 1 trial | ISABELA 2 trial | |||||
| 600 mg of Ziritaxestat (n = 174) |
200 mg of Ziritaxestat (n = 175) |
Placebo (n = 174) |
600 mg of Ziritaxestat (n = 259) |
200 mg of Ziritaxestat (n = 260) |
Placebo (n = 258) |
|
| TEAEs | ||||||
| ≥1 TEAE | 137 (78.7) | 148 (84.6) | 147 (84.5) | 210 (81.1) | 223 (85.8) | 195 (75.6) |
| Serious TEAE | 38 (21.8) | 38 (21.7) | 36 (20.7) | 64 (24.7) | 63 (24.2) | 42 (16.3) |
| Severity of worst TEAE | ||||||
| Died | 9 (5.2) | 6 (3.4) | 8 (4.6) | 22 (8.5) | 20 (7.7) | 10 (3.9) |
| Life-threatening | 3 (1.7) | 5 (2.9) | 4 (2.3) | 5 (1.9) | 1 (0.4) | 4 (1.6) |
| Severe | 29 (16.7) | 35 (20.0) | 26 (14.9) | 38 (14.7) | 44 (16.9) | 33 (12.8) |
| Moderate | 82 (47.1) | 69 (39.4) | 80 (46.0) | 111 (42.9) | 108 (41.5) | 108 (41.9) |
| Mild | 14 (8.0) | 33 (18.9) | 29 (16.7) | 34 (13.1) | 50 (19.2) | 40 (15.5) |
| TEAE related to treatment | ||||||
| Study drug | 60 (34.5) | 53 (30.3) | 53 (30.5) | 96 (37.1) | 80 (30.8) | 70 (27.1) |
| Pirfenidone | 22 (12.6) | 28 (16.0) | 26 (14.9) | 19 (7.3) | 34 (13.1) | 30 (11.6) |
| Nintedanib | 50 (28.7) | 39 (22.3) | 26 (14.9) | 80 (30.9) | 54 (20.8) | 42 (16.3) |
| Dose reductions, interruptions, or discontinuations | ||||||
| Study drug | ||||||
| Permanently stopped | 18 (10.3) | 10 (5.7) | 13 (7.5) | 29 (11.2) | 27 (10.4) | 18 (7.0) |
| Interrupted | 30 (17.2) | 29 (16.6) | 23 (13.2) | 57 (22.0) | 37 (14.2) | 33 (12.8) |
| Reduced | 9 (5.2) | 6 (3.4) | 3 (1.7) | 30 (11.6) | 12 (4.6) | 9 (3.5) |
| Pirfenidone | ||||||
| Permanently stopped | 3 (1.7) | 2 (1.1) | 4 (2.3) | 8 (3.1) | 3 (1.2) | 8 (3.1) |
| Interrupted | 4 (2.3) | 4 (2.3) | 5 (2.9) | 8 (3.1) | 9 (3.5) | 5 (1.9) |
| Reduced | 1 (0.6) | 3 (1.7) | 3 (1.7) | 5 (1.9) | 6 (2.3) | 2 (0.8) |
| Nintedanib | ||||||
| Permanently stopped | 4 (2.3) | 6 (3.4) | 0 | 10 (3.9) | 3 (1.2) | 2 (0.8) |
| Interrupted | 13 (7.5) | 10 (5.7) | 10 (5.7) | 25 (9.7) | 19 (7.3) | 14 (5.4) |
| Reduced | 7 (4.0) | 3 (1.7) | 6 (3.4) | 24 (9.3) | 8 (3.1) | 10 (3.9) |
Abbreviation: TEAE, treatment-emergent adverse event.
a
The events occurred during the trial, on or after the start of study drug intake, and within 30 days after the last dose of study drug until the end of the trial.