Table 5

Hepatic adverse events and elevations in hepatic enzymes and bilirubin in the SENSCIS trial

Nintedanib
(n=288)
Placebo
(n=288)
Hepatic adverse event * 40 (13.9)9 (3.1)
Elevation in ALT and/or AST
 ≥3× ULN14 (4.9)2 (0.7)
 ≥5× ULN3 (1.0)1 (0.3)
 ≥8× ULN01 (0.3)
Elevation in ALT and/or AST≥3× ULN and in bilirubin ≥2× ULN 00
Elevation in total bilirubin
 ≥1.5× ULN1 (0.3)0
 ≥2× ULN1 (0.3)0
Elevation in alkaline phosphatase
 ≥1.5× ULN10 (3.5)3 (1.0)
 ≥2× ULN3 (1.0)0
  • Data are n (%) of patients with ≥1 such event reported over 52 weeks (or until 28 days after last trial drug intake for patients who discontinued trial drug before week 52).

  • *Based on the standardised MedDRA query ‘liver related investigations, signs and symptoms’ (broad definition).

  • ALT, alanine aminotransferase; AST, aspartate aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities; ULN, upper limit of normal.