“…For this approach, we used the GRiP pediatric-specific drug-event reference set for nonvaccines, which composes 256 unique DECs, 37 of which are classified as positive control pairs, 90 as negative control pairs, and the remainder unclassifiable. 20 We calculated standard performance metrics: area under the curve (AUC) (calculated by varying the threshold for the ROR value), sensitivity, specificity, positive predictive value, and negative predictive value at the predefined threshold of ROR > 1 and number of reports ≥3 in the full and restricted settings. Since the AUC assesses performance based upon the entire reference set and may potentially hide different patterns across DECs, we also looked at the change per DEC for the positive and negative controls.…”