Ben even wat dieper gaan graven omtrent de fase IIa studies.. Ik denk dat dit de neven effecten zijn die we kunnen b-verwachten...
For S2, 20 adverse events were reported by 11 patients: 7 of 23 in the GFT505 group and 4 of 24 in the placebo group. Six of these adverse events were considered to possibly be related to GFT505: atrial fibrillation, which was diagnosed at the week 4 visit in a 75-year-old male patient with a long history of hypertension (n = 1), back pain (n = 1), diarrhea (n = 1), gastritis (n = 1), flatulence (n = 1), and gastrointestinal hypermotility (n = 1). No abnormal evolutions of laboratory values were observed from baseline to end point. All safety parameters including ionogram, hematological parameters, creatine phosphokinase, and homocysteine (Tables 2 and ?and3)3) concentrations remained steady throughout the study without difference between treatment groups. However, a slight and reversible increase of plasma creatinine was observed in the S2 GFT505 group (5 ± 9.5 µmol/L vs. baseline; P = 0.02, t test)