Subjects n | 7 | 5 | 2 | 4 | 4 | 4 | 11 | 13 |
Any AE | 2 (28.6) | 2 (40.0) | 0 | 0 | 3 (75.0) | 1 (25.0) | 6 (54.5) | 9 (69.2) |
Serious AEs | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) | 0 |
Investigator-defined drug-related AEs | 1 (14.3) | 1 (20.0) | 0 | 0 | 1 (25.0) | 0 | 3 (27.3) | 7 (53.8) |
Most common AEsƒ | | | | | | | | |
Vomiting | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 (38.5) |
Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) | 4 (30.8) |
Diarrhoea | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) | 2 (15.4) |
Nasopharyngitis | 0 | 0 | 0 | 0 | 1 (25.0) | 0 | 0 | 2 (15.4) |
Abdominal discomfort | 0 | 1 (20.0) | 0 | 0 | 0 | 0 | 1 (9.1) | 0 |
Stomatitis | 0 | 0 | 0 | 0 | 1 (25.0) | 0 | 0 | 1 (7.7) |
Alanine aminotransferase increased## | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) | 0 |
Aspartate aminotransferase increased## | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) | 0 |
AEs leading to discontinuation of study drug | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) | 2 (15.4) |
Transaminases increased | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) | 1 (7.7) |
Vomiting | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7.7) |