Follow-up of Adverse Events. All AEs occurring during the study are to be followed up in accordance with good medical practice until resolved or judged no longer clinically significant, or if a chronic condition, until fully characterized. All follow-up results are to be reported to the Sponsor (or an authorized representative).
Follow-up of Adverse Events. All adverse events must be followed with appropriate medical management until resolved. For selected adverse events, a [*] of the [*] with the [*] may be conducted if considered both [*]. Any [*], however, will be approved in advance by BioMedicines.
Follow-up of Adverse Events. All AEs must be reported in detail on the appropriate page of the eCRF and followed until they are resolved or stabilized as determined by the investigator and/or medical monitor.
Follow-up of Adverse Events. All reported AEs at study exit will be followed by the Clinical Investigator (or his/her designee) until the event is resolved or determined to be irreversible, chronic, or stable. In addition, on a case-by-case basis, RIBOMIC (or designee) may request follow up beyond the end of the study. If RIBOMIC requests follow-up on an individual SAE or designated SAE, site response to follow-up requests should be e-mailed to xxxxx.xxx@xxxxxxx.xxx.
Follow-up of Adverse Events and Serious Adverse Events
