•The investigator will use clinical judgment to determine the relationship. •Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well as the temporal relationship of the event to study intervention administration will be considered and investigated. •The investigator will also consult the Investigat or’s Brochure (IB) and/or Product Information, for marketed products, in his/her assessment. •For each AE/SAE, the investigator must document in the medical notes that he/she hasreviewed the AE/SAE and has provided an assessment of causality. •There may be situations in which an SAE has occurred and the investigator has minimal information to include in the initial report to Sponsor. However, it is very important that the investigator always make an assessment of causality for every event before the initial transmission of the SAE data to Sponsor. •The investigator may change his/her opinion of causality in light of follow-up information and send a SAE follow-up report with the updated causality assessment. •The causality assessment is one of the criter ia used when determining regulatory reporting requirements. Follow-up of AEs and SAEs If only limited information is initially available, follow-up re ports are required. (Note: Follow- up SAE reports must include the same investigator term(s) initially reported.) Revised Protocol No.: 04 Date: 31-May-2019 176 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS If an ongoing SAE changes in its intensity or relationship to study tr eatment or if new information becomes available, the SAE report must be updated and submitted within 24 hours to BMS (or designee) using the same procedure used for transmitting the initial SAE report. All SAEs must be followed to resolution or stabilization. REPORTING OF SAES TO SPONSOR OR DESIGNEE •SAEs, whether related or not related to study treatment, and pregnancies must be reported to BMS (or designee) immediately within 24 hours of awareness of the event. •SAEs must be recorded on the SAE Report Form.