Criteria for discontinuing or modifying allocated interventions {11b}
organ-threatening, infection
INFECTION
In addition to the standard criteria, the trial therapy has to be terminated prematurely for the following reasons: introduction of mTOR inhibitors, co-stimulation blockers or cyclosporine; necessity for significant additional long-term immunosuppression or immune modulation; necessity for long-term termination of TAC; and any condition that is not covered by the additional rules and needs a TAC target significantly higher or lower than the standard of care.The trial therapy might be terminated prematurely for the following reasons: rejection as defined by the primary endpoint and severe infection (life- or organ-threatening). In these circumstances, the PI decides if TTV-guided TAC dosing will be stopped and the patient will continue the study following the protocol of the control arm.