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. 2018 Aug 20;8(4):2045894018797273. doi: 10.1177/2045894018797273

Table 2.

Detailed description of the 22 patients who experienced elevations in alanine and aspartate aminotransferases and clinical failure event(s), if any, during the AMBITION trial.

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.