GPT and Failure to thrive: Nine discontinuations were from drug-related AEs, of which 7 were serious (grade 3 elevated aspartate transaminase and alanine transaminase; grade 4 cerebral hemorrhage; grade 3 failure to thrive; grade 4 genital tract fistula; grade 4 myocardial infarction; grade 3 thrombosis; and grade 3 pulmonary embolism).