Oncology

RECIST 1.1 target lesion measurements, non-target lesion qualitative assessments, and overall response classifications across solid tumor studies. Independent central review (BICR) and investigator reads stored separately.

Somatic and germline variant calls (SNV, indel, CNV, fusion) from tumor and matched normal next-generation sequencing. Aligned to GRCh38, annotated via VEP 110.

PD-L1 IHC scoring (TPS, CPS, IC) using 22C3, 28-8, SP142, SP263 assays. Used for stratification in immunotherapy studies.

Definition of OS, including censoring rules consistent across oncology trials per FDA 2018 oncology endpoint guidance.

ctDNA fragment counts and variant allele frequencies from Guardant360 CDx and Natera Signatera personalized panels.

CTCAE v5 graded adverse events with MedDRA 27.0 coding for oncology safety analyses. Linked to Argus PV cases via case_id.

Radiomic features (Pyradiomics 3.1) extracted from tumor lesions on CT/MRI for response prediction modeling. IBSI-compliant feature set.