9.2 A dverse Events The definitions of an AE or SAE can be found in Appendix 3 . Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology, which were exacerbated by the induction of autoimmunity. Information supporting the assessment will be collected on the participant’s CRF. AEs will be reported by the pa rticipant (or, when appropriate, by a caregiver, surrogate, or the participant’s legally au thorized representative). The investigator and any designees are responsible for detecting, doc umenting, a nd reporting events that meet the definition of an AE or SAE and remain responsible for following up AEs that are serious, are considered related to the study tr eatment or the study, or caused the participant to discontinue before completing the study. Contacts for SAE reporting are specified in Appendix 3. Revised Protocol No.: 04 Date: 31-May-2019 102 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS 9.2.1 Time Period and Frequency for Collecting AE and SAE Information The collection of non-serious AE information shoul d begin at the initiation of study treatment until 100 days of the last dose of study treatment, at the time points specified in the Schedule of Activities ( Section 2 ). Following the participant’s written consent to participate in the study, all SAEs, whether related or not related to study treatment, must be collecte d, including those thought to be associated with protocol-specified procedures. All SAEs that occur during the screening period and within 100 days of the last dose of st udy treatment must be collected. If applicable, SAEs that relate to any later protocol-specified procedure (eg, a follow-up skin biopsy) must be collected. For participants assigned to treatment and never treated with study treatment, SAEs should be collected for 30 days from the date of treatment assignment.The investigator must report any SAE that occurs after these time periods and that is believed to be related to study treatment or protocol-specified procedure. •Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded on the appropriate section of the CRF section. •All SAEs will be recorded and reported to the Sponsor or designee within 24 hours, as indicated in Appendix 3 . •The investigator will submit any updated SAE data to the Sponsor within 24 hours of this being available. An SAE report should be completed for any event where doubt exists regarding its seriousness. If the investigator believes that an SAE is not rel ated to study treatment, but is potentially related to the conditions of the study (such as withdra wal of previous therapy or a complication of a study procedure), the relationship should be specified in the narrative section of the SAE Report Form.Investigators are not obligated to actively seek AEs or SAEs in former study participants. However, if the investigator learns of any SAE, including a d eath, at any time after a participant has been discharged from the study, and he/she considers the event reasonably related to the study treatment or study participation, the inve stigator must promptly notify the Sponsor. The method of evaluating and assessing causality of AEs and SAEs and the procedures for completing and reporting/transmitting SAE reports are provided in Appendix 3. 9.2.2 Method of Detecting AEs and SAEs Adverse events can be spontaneously reported or elicited duri ng open-ended questioning, examination, or evaluation of a participant. Care should be taken not to introduce bias when collecting AE and/or SAEs. Inquiry about specific AEs should be guided by clinical judgement in the context of known adverse events, when appropriate for the program or protocol. Revised Protocol No.: 04 Date: 31-May-2019 103 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS 9.2.3 Follow-up of AEs and SAEs •Non-serious AEs should be followed to resolution or stabilization, or reported as SAEs if they become serious (see Appendix 3). •Follow-up is also required for non-serious AEs that cause interruption or discontinuation of study treatment and for those present at the end of study treatmen t as appropriate.