Table 2.
Patient ID | Randomized treatment | Treatment at time of first elevation in ALT/AST | Days after IP initiation first ALT/AST elevation observed | Description of clinical failure event(s), if applicable |
---|---|---|---|---|
313 | Combination | Combination | 59 | Not applicable |
1563 | Combination | Combination | 225 | Not applicable |
191 | Combination | Combination | 699 | Not applicable |
192 | Combination | Combination | 288 | Death |
242 | Combination | Combination | 83 | Hospitalization, disease progression, unsatisfactory long-term clinical response |
872 | Combination | Combination | 60 | Disease progression |
1158 | Combination | Combination | 699 | Not applicable |
1073 | Combination | Combination | 372 | Not applicable |
588 | Combination | None: Combination IP stopped on day 9 | 29 | Death |
771 | Combination | Combination | 412 | Not applicable |
794 | Combination | Combination | 15 | Hospitalization, death |
1107 | Ambrisentan | Ambrisentan | 106 | Not applicable |
621 | Ambrisentan | Ambrisentan | 814 | Disease progression, hospitalization, unsatisfactory long-term clinical response |
631 | Ambrisentan | Ambrisentan | 141 | Disease progression, hospitalization |
385 | Ambrisentan | Ambrisentan | 507 | Not applicable |
144 | Ambrisentan | Ambrisentan | 562 | Not applicable |
1539 | Ambrisentan | BCT | 127 (AST elevation) | Hospitalization, death |
142 (AST and TBili elevation) | ||||
153 | Ambrisentan | Ambrisentan | 765 | Death |
41 | Tadalafil | Tadalafil | 142 | Not applicable |
1188 | Tadalafil | Tadalafil | 158 | Not applicable |
1181 | Tadalafil | Tadalafil | 143 | Not applicable |
583 | Tadalafil | None: BCT IP stopped on day 874 | 901 | Disease progression, hospitalization, death |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BCT, blinded combination therapy; IP, investigational product; TBili, total bilirubin.