Time Period and Frequency for Collecting. AE and SAE Information All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study medication, at the time points specified in Section 1.3. Medical occurrences that begin before the start of study medication but after obtaining informed consent will be recorded as pretreatment AEs. This does not include pretreatment or post-treatment complications that occur as a result of protocol-mandated procedures (eg, invasive procedures, such as venipuncture or biopsy), which should be reported as AEs. Pregnancy is not an AE. A pregnancy occurring after the start of study medication should be reported on the pregnancy forms, as described in Section 10.3, Appendix 3. All SAEs will be recorded and reported to the Sponsor or the designee immediately and under no circumstance should this exceed 24 hours, as indicated in Section 10.3 (Appendix 3). The Investigator will submit any updated SAE data to the Sponsor within 24 hours of it being available. Investigators are not obliged to actively seek AE or SAE data after conclusion of the study participation. However, if the Investigator learns of any SAE, including a death, at any time after a patient has been discharged from the study, and he/she considers the event to be reasonably related to the study medication or study participation, the Investigator must promptly notify the Sponsor.
