| English term or phrase: IVRS investigational product vial assignment | Visits 9, 10, 11, 12, 13, 14, 16, 17, 18, 19, 20, 21, 23, 24, 25, 26, 27, 29, 30, 31, 32, 33, 35, 36, 37, 38, 39, and 40
13) Take vital signs
14) Obtain IVRS investigational product vial assignment
15) Assess for AEs and SAEs
16) Update and record concomitant medications
17) Collect urine for pregnancy test; ensure pregnancy test result is negative
18) Administer sifalimumab
19) Take vital signs approximately every 15 minutes during administration of the investigational product, immediately after the infusion (within 10 minutes after the infusion has stopped), and approximately every 30 minutes after the completion of the infusion until vital signs are stable, and/or the investigator considers the subject to be clinically stable.
20) Take blood pressure and heart rate immediately prior to discharge from the site |
| |