Criteria for discontinuing or modifying allocated interventions {11b}
infection, hepatic injury, acute liver decompensation
INFECTION, EVENT
Patients may discontinue treatment or withdraw consent to participate in either trial at any time without any justification. They may also discontinue if they are repeatedly non-compliant with important trial procedures, need to take concomitant medication that interferes with the safety or efficacy of the trial treatment, experience a severe infection, meet the criteria for hepatic injury (increased liver function tests), have an acute liver decompensation event, have worsening of liver function, have a QT/QTcF interval of >500 ms or an increase of QT/QTcF of >60 ms from baseline, have not successfully completed the dose-titration period or become pregnant. If a patient permanently discontinues trial medication, an early discontinuation visit is required within 7 days of medication discontinuation, and a follow-up visit should be performed 4 weeks after the early discontinuation visit. The investigator may discontinue patients at any time, based on their clinical judgement.If a patient has an AE that may be related to BI 685509 treatment, based on the investigator’s judgement, trial medication can be interrupted, or the dose can be reduced if the patient has successfully completed dose titration.