Safety reporting
incapacityCongenital anomalies, disability, CRF
PCT, ADVERSE EVENTS, DRUG REACTION, CRF, EVENTS, EVENTS
The trial population consists of hospitalised children. The primary composite safety outcome includes instances of the following events, to be recorded as part of routine data collection, and these will therefore DeathLife-threatening eventReadmission to hospital or prolongation of hospitalisationThese adverse events will instead be recorded in participants’ notes and on the relevant case report forms (CRFs). The following events will be reported as SAEs within 24 h:Events resulting in persistent or significant disability or incapacityCongenital anomalies or birth defectsThe following non-serious adverse events (AEs) will also be recorded as part of routine follow-up at 28 days:
Non-serious AEs potentially attributable to PCT test and step-down approachSuspected drug reactions defined by the Liverpool Causality Assessment ToolThese events will be recorded in participants’ notes and on the relevant CRF. Other non-serious AEs will not be collected. (S)AEs will be categorised by seriousness and summarised by arm. The proportion of patients per arm experiencing each AE (if ≥ 2% of patients in either arm) and the risk ratio between arms will be presented graphically using a Cleveland dot plot [