Table 2.
Summary of TEAEs experienced by patients who entered Part 2 of APeX-J.
| n (%) | TEAEs starting in Part 1 (Week 1 to Week 24) |
TEAEs starting in Parts 2 or 3 (Week 24 to Week 104) |
||
|---|---|---|---|---|
| All 150 mg | All 110 to 150 mg | All 150 mg | All 110 to 150 mg | |
| n | 9 | 8 | 9 | 8 |
| Any TEAE | 9 (100) | 8 (100) | 7 (77.8) | 7 (87.5) |
| Any drug-related TEAE | 3 (33.3) | 2 (25.0) | 1 (11.1) | 0 |
| Any TESAE | 0 | 1 (12.5) | 1 (11.1) | 1 (12.5) |
| Any drug-related TESAE | 0 | 0 | 0 | 0 |
| Any Grade 3 or 4 TEAE | 0 | 1 (12.5) | 2 (22.2) | 0 |
| Any drug-related Grade 3 or 4 TEAE | 0 | 0 | 1 (11.1) | 0 |
| Any TEAE leading to interruption of study druga | 2 (22.2) | 1 (12.5) | 0 | 0 |
| Any TEAE leading to discontinuation of study drug | 0 | 0 | 1 (11.1) | 0 |
| Any investigator-identified rashb | 2 (22.2) | 0 | 0 | 1 (12.5) |
| Any abdominal-related gastrointestinal TEAE | 4 (44.4) | 3 (37.5) | 1 (11.1) | 1 (12.5) |
| Any abdominal-related gastrointestinal TEAE leading to study drug discontinuation | 0 | 0 | 0 | 0 |
| Any drug-related abdominal-related gastrointestinal TEAE | 2 (22.2) | 2 (25.0) | 0 | 0 |
Abbreviations: TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event.
a
Study drug interruption is when study drug is temporarily stopped and then resumed.
b
Investigator-identified rash was a TEAE of special interest