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Table 3 Adverse events

From: A phase 2 randomised controlled trial of serelaxin to lower portal pressure in cirrhosis (STOPP)

SNIMPAdverse eventSAE/SARSeverityRelatedness to IMPExpectedness
002PlaceboDiarrhoeaNoMildN/AN/A
003SerelaxinSyncope on inserting VenflonNoMildUnrelatedUnexpected
003SerelaxinSyncope on inserting hepatic venous catheterNoMildUnrelatedUnexpected
003SerelaxinSyncope on removing hepatic venous catheterNoMildUnrelatedUnexpected
003SerelaxinRight upper-quadrant ache reported at 24 h follow-upNoMildUnrelatedUnexpected
005SerelaxinMean diastolic BP < 60 mmHg (58.3 mmHg at IMP + 30 min)NoMildPossibly relatedExpected
006SerelaxinProlonged QTc on ECG after 2 h of serelaxin infusionNoMildPossibly relatedUnexpected
008SerelaxinBilirubin riseNoMildUnrelatedUnexpected
012SerelaxinProlonged QTc on ECG during recovery period (normal throughout infusion)NoMildPossibly relatedUnexpected
014SerelaxinSyncope on inserting VenflonNoMildUnrelatedUnexpected
014SerelaxinSyncope on inserting hepatic venous catheterNoMildUnrelatedUnexpected
014SerelaxinDental abscessNoMildUnrelatedUnexpected
016SerelaxinFemoral artery punctureNoMildUnrelatedUnexpected
  1. BP blood pressure, ECG electrocardiogram, IMP investigational medicinal product, N/A not applicable, QTc corrected QT interval, SAE serious adverse event, SAR serious adverse reaction, SN study participant number