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Table 6 Incidence of treatment-emergent abnormal value of ALT or AST

From: Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer’s disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study

StudyALZ2002ALZ2004
PeriodDouble-blindDouble-blindOpen-label
Treatment groupPlaceboAta 10 mgAta 50 mgPlaceboAta 10 mgAta 25 mgPlacebo/5 mgPlacebo/25 mg5 mg25 mg
AST or ALT,n39343735292615142622
> ULN to ≤ 2× ULN,n(%)05 (14.7)8 (21.6)2 (5.7)1 (3.4)7 (26.9)4 (26.7)2 (14.3)3 (11.5)7 (31.8)
> 2× ULN to ≤ 3× ULN,n(%)02 (5.9)1 (2.7)02 (6.9)1 (3.8)02 (14.3)00
> 3× ULN,n(%)1 (2.6)2 (5.9)2 (5.4)02 (6.9)1 (3.8)1 (6.7)3 (21.4)00
  1. ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal
  2. For double-blind period 1, baseline is defined as the pre-dose baseline value from the preceding parent ALZ2002 study. For open-label period 2, baseline is defined as the last value taken on or before the day of the first dose of study drug in the open-label period