Table 3 Adverse events
From: A phase 2 randomised controlled trial of serelaxin to lower portal pressure in cirrhosis (STOPP)
SN | IMP | Adverse event | SAE/SAR | Severity | Relatedness to IMP | Expectedness |
|---|---|---|---|---|---|---|
002 | Placebo | Diarrhoea | No | Mild | N/A | N/A |
003 | Serelaxin | Syncope on inserting Venflon | No | Mild | Unrelated | Unexpected |
003 | Serelaxin | Syncope on inserting hepatic venous catheter | No | Mild | Unrelated | Unexpected |
003 | Serelaxin | Syncope on removing hepatic venous catheter | No | Mild | Unrelated | Unexpected |
003 | Serelaxin | Right upper-quadrant ache reported at 24 h follow-up | No | Mild | Unrelated | Unexpected |
005 | Serelaxin | Mean diastolic BP < 60 mmHg (58.3 mmHg at IMP + 30 min) | No | Mild | Possibly related | Expected |
006 | Serelaxin | Prolonged QTc on ECG after 2 h of serelaxin infusion | No | Mild | Possibly related | Unexpected |
008 | Serelaxin | Bilirubin rise | No | Mild | Unrelated | Unexpected |
012 | Serelaxin | Prolonged QTc on ECG during recovery period (normal throughout infusion) | No | Mild | Possibly related | Unexpected |
014 | Serelaxin | Syncope on inserting Venflon | No | Mild | Unrelated | Unexpected |
014 | Serelaxin | Syncope on inserting hepatic venous catheter | No | Mild | Unrelated | Unexpected |
014 | Serelaxin | Dental abscess | No | Mild | Unrelated | Unexpected |
016 | Serelaxin | Femoral artery puncture | No | Mild | Unrelated | Unexpected |