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Table 10 Percentage of patients in integrated double-blind studies with treatment-emergent high hepatic laboratory measures at any timea

From: Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

AnalytePlaceboGalcanezumab
120 mg240 mg
 N = 1202
n (%)
N = 591
n (%)
N = 598
n (%)
ALT ≥3x ULN4 (0.3)1 (0.2)2 (0.3)
ALT ≥5x ULN0 (0.0)1 (0.2)1 (0.2)
ALT ≥10x ULN0 (0.0)1 (0.2)0 (0.0)
 N = 1274
n (%)
N = 635
n (%)
N = 636
n (%)
AST ≥3x ULN1 (0.1)1 (0.2)1 (0.2)
AST ≥5x ULN0 (0.0)0 (0.0)0 (0.0)
AST ≥10x ULN0 (0.0)0 (0.0)0 (0.0)
 N = 1295
n (%)
N = 648
n (%)
N = 658
n (%)
ALP ≥2x ULN0 (0.0)0 (0.0)0 (0.0)
 N = 1306
n (%)
N = 647
n (%)
N = 660
n (%)
TBIL ≥2x ULN0 (0.0)0 (0.0)0 (0.0)
  1. Abbreviations: ALT Alanine aminotransferase, ALP Alkaline phosphatase, AST Aspartate aminotransferase, N Number of patients in the baseline category and at least one postbaseline measurement, n Number of patients with at least one value in the postbaseline category, TBIL Total bilirubin, ULN Upper limit of normal
  2. aIncludes all patients with at least one post-baseline measurement and those with missing baseline values