Concomitant Medications and Procedures. All concomitant medications and supportive therapy taken within four weeks of Cycle 1, Day 1 and through 30 days after last study treatment must be recorded on the appropriate electronic case report form (eCRF). The identity of all medications, dosage, and route of administration, frequency, duration of administration, and indication for use will be recorded in the appropriate sections of the eCRF.
Concomitant Medications and Procedures. All patients should be given maximal supportive therapy during the course of the study. All medications and supportive therapies (including renal replacement therapy and ventilation support) that are administered from Screening through the Day 28 follow-up, including the dose and indication, must be recorded on the appropriate CRF and in the source documents. Supportive therapy that is ongoing at baseline will be permitted during the treatment phase of the study. No other experimental therapy is permitted. Concomitant medications for other medical conditions are permitted as clinically indicated. Concomitant procedures, such as dialysis, mechanical ventilation, and relevant procedures used to diagnose or treat a serious adverse event (SAE), will also be recorded from screening through Day 28. Start and stop date(s)/time(s), dose, and amount administered will be recorded for vasopressors administered up to 48 hours prior to, during, and after LJPC-501 administration. Total daily dose for each vasopressor administered through Day 28 may be recorded after completion of LJPC-501 administration.
Concomitant Medications and Procedures. All concomitant medications and supportive therapy taken within four weeks of Cycle 1, Day 1 and through 30 days after last study treatment must be recorded in the clinical database.
