... requires hospitalization or prolongs existing inpatients hospitalization; results in persistent or significant disability or ...
Inpatient or outpatient with presence of indwelling CVC (ie, totally implantable port, tunneled or non-tunneled CVC, ... Subject must be willing to comply with all study procedures, whether inpatient or outpatient, for the duration of the study. ...
Required inpatient hospitalization or prolongation of existing hospitalization; d.) Resulted in persistent or significant ...
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient ...