Follow-up of Adverse Events and Serious Adverse Events. The reference time point for adverse events is the period from signing the informed consent through the final study visit. Adverse events/experiences will be followed until the event resolves or stabilizes and must be recorded on the AE eCRF. If clinically significant findings are present at the Study termination, a determination will be made about each persistent clinically significant finding. If not clinically important (i.e., does not pose a health risk to the subject) then follow-up will cease. If clinically important, additional follow-up will continue on a case-by-case basis until satisfactory resolution or resolution with sequelae is determined. Any SAE assessed as not related to Study drug will be followed as clinically indicated until its resolution or, if not resolving, until considered stable or until the completion study visit, whichever comes first. Any SAE assessed as related to Study drug will be followed as clinically indicated until its resolution or resolution with sequelae is determined. Outcome may be classified as resolved, resolved with sequelae, continuing, fatal, or unknown (lost to follow-up).
Follow-up of Adverse Events and Serious Adverse Events. All AEs determined not to be study drug related will be followed through to week 48, early discontinuation or lost to follow-up will be noted as “continuing” if not resolved at this visit. Any AE that is determined to be study drug related will be followed to resolution or stabilization unless the patient discontinues the study prior to week 48 or is lost to follow-up. All SAEs, regardless of relationship to study drug, will be followed until resolution or stabilization unless the patient discontinues the study prior to week 48 or is lost to follow-up.
