Safety
ADVERSE EVENTS, ADVERSE REACTIONS, EVENT
All adverse events for INTEGRATE IIa and INTEGRATE IIb will be recorded from the first dose of study treatment until 30 days (90 days for nivolumab) following last treatment dose. The investigator is responsible for ensuring all adverse events observed by the investigator or reported by the trial participants are documented in electronic case report forms (eCRFs). Serious adverse events (SAEs), including suspected unexpected serious adverse reactions (SUSAR) occurring during the study must be reported to the sponsor within 24 h of investigational site staff becoming aware of the event according to local procedures. The sponsor is responsible for the medical review of all SAEs and for their notification to the appropriate ethics committees and local authorities.