Supplementary Table S1 Reasons for False Negative and False Positive Case Assessments
Discrepancy Reason Count
(Duplicates) False
Negative Threshold reduced conservatively 5 (1)
False
Negative Serious liver injury AE 1 (0)
False Positive Symptoms do not correlate with enzyme elevation 9 (5) False Positive Enzyme elevation duration not 2wks 26 (13) False Positive Laboratory values not available during manual
review 8 (1)
False positive category of symptoms that did not correlate with enzyme elevation includes cases where there was no temporal association as well as cases that were confounded by other non-hepatic AEs. Enzyme elevation duration not two weeks includes cases where enzymes were elevated for less than two weeks as well as cases where enzyme elevation duration was not able to be determined.