Sanofi registry for stage 2 T1D and Tzield treatment: review notes

Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.

Registry: NCT06481904. Endpoint reviewed: Number of adverse events of special interests (AESI) (Throughout the study, approximately 10 years); Number of serious adverse events (SAE) (Throughout the study, approximately 10 years); Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy (From start of pregnancy to 12 months post-partum); Number of maternal pregnancy-related events (From start of pregnancy to 12 months post-partum); Developmental outcomes of the infant (From birth of infant to 12 months). Eligibility reviewed: Age unspecified to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.