Medical History and Concomitant Medications. Collect medical history information, including information on all medications used within the past 30 days. Include herbal therapies, vitamins, and all over-the-counter as well as prescription medications. Throughout the subject’s participation, obtain information on any changes in medical health and/or the use of concomitant medications.
Medical History and Concomitant Medications. A full medical history will be taken during Screening and should include the patient’s demographic information, surgical history, concurrent medical conditions, concomitant medications and procedures. All medications and supportive therapies that are administered during administration of LJPC-501 and up to Day 28, including the indication, must be recorded on the appropriate CRF and in the source documents. For vasopressor medications only, start and stop date(s), dose, and amount administered, including dose adjustments, will also be recorded for vasopressors administered up to 2 days prior to, during LJPC-501 administration, and through Day 28. The total daily dose of administered vasopressors may be recorded after completion of LJPC-501 administration. Concomitant procedures, such as dialysis, mechanical ventilation, and any procedures used to diagnose or treat an SAE, will also be recorded though Day 28.
Medical History and Concomitant Medications. Ocular and non-ocular medical history and concomitant medications will be collected at Visit 1 (and at other visits as needed, i.e., due to AE) and documented in the source documents. All relevant medical conditions, including currently active conditions, diagnosed chronic conditions, and conditions resolved within the past year will be documented. Habitual lens information and medications taken within 30 days prior to Visit 1 will be recorded in the source documentation. Include herbal therapies, vitamins, and all over-the-counter as well as prescription medications. Throughout the subject’s participation, obtain information on any changes in medical health and/or the use of concomitant medications and record in subject source documents.
