Overview of safety profile
| Event, n (%) . | R/R SAA n = 14 . | Treatment-naïve SAA n = 37 . | All patients N = 51 . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | |
| AEs | 14 (100) | 8 (57.1) | 37 (100) | 23 (62.2) | 51 (100) | 31 (60.8) |
| Treatment related | 13 (92.9) | 4 (28.6) | 28 (75.7) | 8 (21.6) | 41 (80.4) | 12 (23.5) |
| SAEs | 6 (42.9) | 2 (14.3) | 23 (62.2) | 17 (45.9) | 29 (56.9) | 19 (37.3) |
| Treatment related | 1 (7.1) | 0 | 2 (5.4) | 1 (2.7) | 3 (5.9) | 1 (2.0) |
| AEs leading to treatment discontinuation | 3 (21.4) | 0 | 4 (10.8) | 2 (5.4) | 7 (13.7) | 2 (3.9) |
| Treatment related | 3 (21.4) | 0 | 4 (10.8) | 2 (5.4) | 7 (13.7) | 2 (3.9) |
| AEs with suspected relationship to eltrombopag by PT (≥10% of total patients) | ||||||
| Increased ALT | 6 (42.9) | 1 (7.1) | 13 (35.1) | 5 (13.5) | 19 (37.3) | 6 (11.8) |
| Increased AST | 6 (42.9) | 0 | 11 (29.7) | 4 (10.8) | 17 (33.3) | 4 (7.8) |
| Increased blood bilirubin | 6 (42.9) | 2 (14.3) | 16 (43.2) | 2 (5.4) | 22 (43.1) | 4 (7.8) |
| AEs leading to treatment discontinuation | ||||||
| Increased ALT | 1 (7.1) | 0 | 3 (8.1) | 2 (5.4) | 4 (7.8) | 2 (3.9) |
| Increased AST | 2 (14.3) | 0 | 1 (2.7) | 1 (2.7) | 3 (5.9) | 1 (2.0) |
| Increased blood bilirubin | 1 (7.1) | 0 | 1 (2.7) | 0 | 2 (3.9) | 0 |
| Drug-induced liver injury | 1 (7.1) | 0 | 0 | 0 | 1 (2.0) | 0 |
| Event, n (%) . | R/R SAA n = 14 . | Treatment-naïve SAA n = 37 . | All patients N = 51 . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | |
| AEs | 14 (100) | 8 (57.1) | 37 (100) | 23 (62.2) | 51 (100) | 31 (60.8) |
| Treatment related | 13 (92.9) | 4 (28.6) | 28 (75.7) | 8 (21.6) | 41 (80.4) | 12 (23.5) |
| SAEs | 6 (42.9) | 2 (14.3) | 23 (62.2) | 17 (45.9) | 29 (56.9) | 19 (37.3) |
| Treatment related | 1 (7.1) | 0 | 2 (5.4) | 1 (2.7) | 3 (5.9) | 1 (2.0) |
| AEs leading to treatment discontinuation | 3 (21.4) | 0 | 4 (10.8) | 2 (5.4) | 7 (13.7) | 2 (3.9) |
| Treatment related | 3 (21.4) | 0 | 4 (10.8) | 2 (5.4) | 7 (13.7) | 2 (3.9) |
| AEs with suspected relationship to eltrombopag by PT (≥10% of total patients) | ||||||
| Increased ALT | 6 (42.9) | 1 (7.1) | 13 (35.1) | 5 (13.5) | 19 (37.3) | 6 (11.8) |
| Increased AST | 6 (42.9) | 0 | 11 (29.7) | 4 (10.8) | 17 (33.3) | 4 (7.8) |
| Increased blood bilirubin | 6 (42.9) | 2 (14.3) | 16 (43.2) | 2 (5.4) | 22 (43.1) | 4 (7.8) |
| AEs leading to treatment discontinuation | ||||||
| Increased ALT | 1 (7.1) | 0 | 3 (8.1) | 2 (5.4) | 4 (7.8) | 2 (3.9) |
| Increased AST | 2 (14.3) | 0 | 1 (2.7) | 1 (2.7) | 3 (5.9) | 1 (2.0) |
| Increased blood bilirubin | 1 (7.1) | 0 | 1 (2.7) | 0 | 2 (3.9) | 0 |
| Drug-induced liver injury | 1 (7.1) | 0 | 0 | 0 | 1 (2.0) | 0 |
Safety analysis set. Based on MedDRA version 26.1, with data cutoff on 4 May 2023.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; PT, preferred term.