Outcome measures
Cancer
ADVERSE EVENT, DISEASE, DISEASE CHARACTERISTIC, APPENDIX, CANCER
Data collected at screening and pre‐infusion visits consisted of patient demographics (age, sex, race, and ethnicity) and clinical disease characteristics (type of MS, disease duration, DMT type, DMT duration, PDDS score, and number of prior ocrelizumab infusions). Infusion procedure variables documented during the infusion included pre‐infusion medications, time to complete the infusion, ocrelizumab dose (mg and mL).The primary outcome was the proportion of patients with IRRs in this study, and in the SaROD historical comparator cohort 1. The SaROD cohort 1 study enrolled patients who had completed ≥1 dose of 600‐mg ocrelizumab according to the US label prior to study screening, then received an additional dose of ocrelizumab 600 mg over the shorter infusion time, as planned with our study design. Severity of IRRs was determined using the Common Terminology Criteria for Adverse Events developed by the National Cancer Institutes and utilized in the OPERA I and II studies.Secondary outcomes included PRO measures of patient experiences with home infusion and number of patient‐reported adverse events (AEs) (Supporting information Appendix 