{ "generated": "2026-10-09", "method": "Method validation (#9) and empirical calibration (#10) for OpenPV disproportionality.\n\nReference set: OMOP 2010 (Ryan et al., Drug Saf 2013) + EU-ADR (Coloma et al., Drug Saf 2013),\nparsed from the OHDSI MethodEvaluation package (492 pairs; 208 positive, 284 negative).\n\nPair -> FAERS mapping\n drug: reference ingredient matched to the OpenPV drug name with the most reports among\n names whose salt-stripped leading ingredient equals it (e.g. ATORVASTATIN -> ATORVASTATIN CALCIUM)\n outcome: the reference set's outcome mapped to a fixed list of MedDRA PTs; a pair's score is\n the MAXIMUM score over its PTs present in FAERS (a common, slightly liberal convention;\n summing PT counts would double-count reports carrying several PTs).\n A pair with no PT row in FAERS (zero or <3 co-reports, outside API coverage) gets the\n 'no signal' score (PRR/ROR/EBGM = 1, IC025 = -inf) and is kept, so sensitivity is not\n inflated by dropping hard cases. Coverage is reported.\n\nMetrics: AUC (Mann-Whitney) with 2,000-sample bootstrap 95% CI; sensitivity/specificity/PPV at\nthe conventional thresholds (Evans: PRR>=2, chi2>=4, n>=3; EB05>=2; IC025>0; ROR lower CI>1).\n\nEmpirical calibration (Schuemie et al., Stat Med 2014): the negative controls' log-ROR estimates\n(with their SEs) are used to fit a systematic-error null N(mu, tau^2) by maximum likelihood; a\ncalibrated two-sided p-value for any pair is 2*Phi(-|log ROR - mu| / sqrt(tau^2 + se^2)).\nCalibrated p-values are then computed for every flagged pair on the site, and the share that\nremain significant after Benjamini-Hochberg is reported. Caveat: the negatives cover only the\n4 OMOP + 10 EU-ADR outcomes, so the null is assumed to transfer to other outcomes.\n", "results": [ { "subset": "all pairs (deduplicated)", "n": 485, "n_pos": 201, "n_neg": 284, "coverage": 0.5958762886597938, "drug_matched": 0.8247422680412371, "auc": { "prr": { "auc": 0.7102165230187093, "ci": [ 0.663653540784458, 0.7548889492917168 ] }, "prr_lo": { "auc": 0.7070807932170136, "ci": [ 0.6581828255233567, 0.7526751082251082 ] }, "ror_lo": { "auc": 0.7069581669119193, "ci": [ 0.6581282572586028, 0.7524959967245577 ] }, "ebgm": { "auc": 0.7107420643262561, "ci": [ 0.6633888788678637, 0.7557617715566535 ] }, "eb05": { "auc": 0.7070807932170136, "ci": [ 0.6583614557100025, 0.7528161213845425 ] }, "ic025": { "auc": 0.707974213439843, "ci": [ 0.6585912896767737, 0.7535468955006415 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 125, "fp": 67, "fn": 76, "tn": 217, "sensitivity": 0.6218905472636815, "specificity": 0.7640845070422535, "ppv": 0.6510416666666666 }, "eb05_ge_2": { "tp": 113, "fp": 53, "fn": 88, "tn": 231, "sensitivity": 0.5621890547263682, "specificity": 0.8133802816901409, "ppv": 0.6807228915662651 }, "ic025_gt_0": { "tp": 134, "fp": 99, "fn": 67, "tn": 185, "sensitivity": 0.6666666666666666, "specificity": 0.6514084507042254, "ppv": 0.575107296137339 }, "ror_lower_gt_1": { "tp": 134, "fp": 104, "fn": 67, "tn": 180, "sensitivity": 0.6666666666666666, "specificity": 0.6338028169014085, "ppv": 0.5630252100840336 } } }, { "subset": "OMOP 2010", "n": 399, "n_pos": 165, "n_neg": 234, "coverage": 0.5413533834586466, "drug_matched": 0.8120300751879699, "auc": { "prr": { "auc": 0.7004403004403005, "ci": [ 0.6501845317490468, 0.750042166675813 ] }, "prr_lo": { "auc": 0.6998704998704999, "ci": [ 0.6492937167638694, 0.749847949235108 ] }, "ror_lo": { "auc": 0.6997150997150997, "ci": [ 0.6492495007572308, 0.7496469097088726 ] }, "ebgm": { "auc": 0.7003885003885004, "ci": [ 0.6495342296856655, 0.7502678054429646 ] }, "eb05": { "auc": 0.7000518000518, "ci": [ 0.6495607206243589, 0.7495912357650976 ] }, "ic025": { "auc": 0.7004144004144004, "ci": [ 0.650185936251425, 0.7494575225638578 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 97, "fp": 52, "fn": 68, "tn": 182, "sensitivity": 0.5878787878787879, "specificity": 0.7777777777777778, "ppv": 0.6510067114093959 }, "eb05_ge_2": { "tp": 87, "fp": 41, "fn": 78, "tn": 193, "sensitivity": 0.5272727272727272, "specificity": 0.8247863247863247, "ppv": 0.6796875 }, "ic025_gt_0": { "tp": 104, "fp": 72, "fn": 61, "tn": 162, "sensitivity": 0.6303030303030303, "specificity": 0.6923076923076923, "ppv": 0.5909090909090909 }, "ror_lower_gt_1": { "tp": 104, "fp": 76, "fn": 61, "tn": 158, "sensitivity": 0.6303030303030303, "specificity": 0.6752136752136753, "ppv": 0.5777777777777777 } } }, { "subset": "EU-ADR", "n": 86, "n_pos": 36, "n_neg": 50, "coverage": 0.8488372093023255, "drug_matched": 0.8837209302325582, "auc": { "prr": { "auc": 0.7711111111111111, "ci": [ 0.6527732683982684, 0.8728412479361245 ] }, "prr_lo": { "auc": 0.7627777777777778, "ci": [ 0.6333959024907456, 0.873925422518907 ] }, "ror_lo": { "auc": 0.7627777777777778, "ci": [ 0.6333959024907456, 0.873925422518907 ] }, "ebgm": { "auc": 0.7711111111111111, "ci": [ 0.6539064536493973, 0.873901525419552 ] }, "eb05": { "auc": 0.7616666666666667, "ci": [ 0.6333742498636116, 0.8742262567697414 ] }, "ic025": { "auc": 0.765, "ci": [ 0.6368198529411764, 0.8781866319444444 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 28, "fp": 15, "fn": 8, "tn": 35, "sensitivity": 0.7777777777777778, "specificity": 0.7, "ppv": 0.6511627906976745 }, "eb05_ge_2": { "tp": 26, "fp": 12, "fn": 10, "tn": 38, "sensitivity": 0.7222222222222222, "specificity": 0.76, "ppv": 0.6842105263157895 }, "ic025_gt_0": { "tp": 30, "fp": 27, "fn": 6, "tn": 23, "sensitivity": 0.8333333333333334, "specificity": 0.46, "ppv": 0.5263157894736842 }, "ror_lower_gt_1": { "tp": 30, "fp": 28, "fn": 6, "tn": 22, "sensitivity": 0.8333333333333334, "specificity": 0.44, "ppv": 0.5172413793103449 } } }, { "subset": "pairs present in FAERS cache", "n": 289, "n_pos": 143, "n_neg": 146, "coverage": 1.0, "drug_matched": 1.0, "auc": { "prr": { "auc": 0.7834562697576396, "ci": [ 0.7297847891573089, 0.8332151604946966 ] }, "prr_lo": { "auc": 0.7963885429638854, "ci": [ 0.742496234362906, 0.8439139305279283 ] }, "ror_lo": { "auc": 0.7960532618066865, "ci": [ 0.7420432664793984, 0.8435151034469741 ] }, "ebgm": { "auc": 0.7876712328767124, "ci": [ 0.7347839726512384, 0.836086697273003 ] }, "eb05": { "auc": 0.7963885429638854, "ci": [ 0.7428196930048292, 0.8439427641452106 ] }, "ic025": { "auc": 0.7988313056806208, "ci": [ 0.7457811245599517, 0.8470233226952273 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 125, "fp": 67, "fn": 18, "tn": 79, "sensitivity": 0.8741258741258742, "specificity": 0.541095890410959, "ppv": 0.6510416666666666 }, "eb05_ge_2": { "tp": 113, "fp": 53, "fn": 30, "tn": 93, "sensitivity": 0.7902097902097902, "specificity": 0.636986301369863, "ppv": 0.6807228915662651 }, "ic025_gt_0": { "tp": 134, "fp": 99, "fn": 9, "tn": 47, "sensitivity": 0.9370629370629371, "specificity": 0.3219178082191781, "ppv": 0.575107296137339 }, "ror_lower_gt_1": { "tp": 134, "fp": 104, "fn": 9, "tn": 42, "sensitivity": 0.9370629370629371, "specificity": 0.2876712328767123, "ppv": 0.5630252100840336 } } }, { "subset": "outcome: acute_kidney_injury", "n": 96, "n_pos": 27, "n_neg": 69, "coverage": 0.5625, "drug_matched": 0.8333333333333334, "auc": { "prr": { "auc": 0.7391304347826086, "ci": [ 0.6191081551034603, 0.8464420995670995 ] }, "prr_lo": { "auc": 0.748792270531401, "ci": [ 0.625, 0.8603207005189027 ] }, "ror_lo": { "auc": 0.7482555018786903, "ci": [ 0.6238850174216027, 0.8591702790271036 ] }, "ebgm": { "auc": 0.7428878153515834, "ci": [ 0.6222328471422675, 0.8508282424812029 ] }, "eb05": { "auc": 0.7477187332259796, "ci": [ 0.6249963240088681, 0.8605402239827856 ] }, "ic025": { "auc": 0.7498658078368223, "ci": [ 0.6276737464157047, 0.8637216605392156 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 21, "fp": 25, "fn": 6, "tn": 44, "sensitivity": 0.7777777777777778, "specificity": 0.6376811594202898, "ppv": 0.45652173913043476 }, "eb05_ge_2": { "tp": 21, "fp": 24, "fn": 6, "tn": 45, "sensitivity": 0.7777777777777778, "specificity": 0.6521739130434783, "ppv": 0.4666666666666667 }, "ic025_gt_0": { "tp": 21, "fp": 26, "fn": 6, "tn": 43, "sensitivity": 0.7777777777777778, "specificity": 0.6231884057971014, "ppv": 0.44680851063829785 }, "ror_lower_gt_1": { "tp": 21, "fp": 27, "fn": 6, "tn": 42, "sensitivity": 0.7777777777777778, "specificity": 0.6086956521739131, "ppv": 0.4375 } } }, { "subset": "outcome: acute_liver_injury", "n": 125, "n_pos": 83, "n_neg": 42, "coverage": 0.664, "drug_matched": 0.84, "auc": { "prr": { "auc": 0.7498565691336776, "ci": [ 0.6663570639710744, 0.8309533774070291 ] }, "prr_lo": { "auc": 0.754302925989673, "ci": [ 0.6735458978772232, 0.8343741908845217 ] }, "ror_lo": { "auc": 0.754302925989673, "ci": [ 0.6735458978772232, 0.8343741908845217 ] }, "ebgm": { "auc": 0.751004016064257, "ci": [ 0.6683999951606658, 0.8312553389963712 ] }, "eb05": { "auc": 0.756310958118187, "ci": [ 0.6760358505925056, 0.8357216565767749 ] }, "ic025": { "auc": 0.7597532989099254, "ci": [ 0.6791506648775509, 0.8390717449630454 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 56, "fp": 9, "fn": 27, "tn": 33, "sensitivity": 0.6746987951807228, "specificity": 0.7857142857142857, "ppv": 0.8615384615384616 }, "eb05_ge_2": { "tp": 51, "fp": 5, "fn": 32, "tn": 37, "sensitivity": 0.6144578313253012, "specificity": 0.8809523809523809, "ppv": 0.9107142857142857 }, "ic025_gt_0": { "tp": 58, "fp": 12, "fn": 25, "tn": 30, "sensitivity": 0.6987951807228916, "specificity": 0.7142857142857143, "ppv": 0.8285714285714286 }, "ror_lower_gt_1": { "tp": 58, "fp": 14, "fn": 25, "tn": 28, "sensitivity": 0.6987951807228916, "specificity": 0.6666666666666666, "ppv": 0.8055555555555556 } } }, { "subset": "outcome: acute_myocardial_infarction", "n": 111, "n_pos": 40, "n_neg": 71, "coverage": 0.43243243243243246, "drug_matched": 0.7657657657657657, "auc": { "prr": { "auc": 0.5575704225352113, "ci": [ 0.4611806470502123, 0.6612989666299766 ] }, "prr_lo": { "auc": 0.5440140845070423, "ci": [ 0.4392548904538341, 0.6547036501080619 ] }, "ror_lo": { "auc": 0.5443661971830986, "ci": [ 0.4392551440329218, 0.6549186720142602 ] }, "ebgm": { "auc": 0.5535211267605634, "ci": [ 0.4572781429189657, 0.6588375537699861 ] }, "eb05": { "auc": 0.5443661971830986, "ci": [ 0.44074074074074077, 0.6548326685831192 ] }, "ic025": { "auc": 0.5440140845070423, "ci": [ 0.43999794238683126, 0.6556331314060783 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 9, "fp": 8, "fn": 31, "tn": 63, "sensitivity": 0.225, "specificity": 0.8873239436619719, "ppv": 0.5294117647058824 }, "eb05_ge_2": { "tp": 5, "fp": 3, "fn": 35, "tn": 68, "sensitivity": 0.125, "specificity": 0.9577464788732394, "ppv": 0.625 }, "ic025_gt_0": { "tp": 13, "fp": 16, "fn": 27, "tn": 55, "sensitivity": 0.325, "specificity": 0.7746478873239436, "ppv": 0.4482758620689655 }, "ror_lower_gt_1": { "tp": 13, "fp": 17, "fn": 27, "tn": 54, "sensitivity": 0.325, "specificity": 0.7605633802816901, "ppv": 0.43333333333333335 } } }, { "subset": "outcome: anaphylaxis", "n": 10, "n_pos": 5, "n_neg": 5, "coverage": 0.9, "drug_matched": 0.9, "auc": { "prr": { "auc": 0.8, "ci": [ 0.4166666666666667, 1.0 ] }, "prr_lo": { "auc": 0.84, "ci": [ 0.5, 1.0 ] }, "ror_lo": { "auc": 0.84, "ci": [ 0.5, 1.0 ] }, "ebgm": { "auc": 0.8, "ci": [ 0.4166666666666667, 1.0 ] }, "eb05": { "auc": 0.84, "ci": [ 0.5, 1.0 ] }, "ic025": { "auc": 0.84, "ci": [ 0.5, 1.0 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 4, "fp": 1, "fn": 1, "tn": 4, "sensitivity": 0.8, "specificity": 0.8, "ppv": 0.8 }, "eb05_ge_2": { "tp": 3, "fp": 1, "fn": 2, "tn": 4, "sensitivity": 0.6, "specificity": 0.8, "ppv": 0.75 }, "ic025_gt_0": { "tp": 5, "fp": 3, "fn": 0, "tn": 2, "sensitivity": 1.0, "specificity": 0.4, "ppv": 0.625 }, "ror_lower_gt_1": { "tp": 5, "fp": 3, "fn": 0, "tn": 2, "sensitivity": 1.0, "specificity": 0.4, "ppv": 0.625 } } }, { "subset": "outcome: aplastic_anaemia", "n": 10, "n_pos": 5, "n_neg": 5, "coverage": 0.8, "drug_matched": 0.9, "auc": { "prr": { "auc": 0.82, "ci": [ 0.5, 1.0 ] }, "prr_lo": { "auc": 0.78, "ci": [ 0.38095238095238093, 1.0 ] }, "ror_lo": { "auc": 0.78, "ci": [ 0.38095238095238093, 1.0 ] }, "ebgm": { "auc": 0.82, "ci": [ 0.5, 1.0 ] }, "eb05": { "auc": 0.78, "ci": [ 0.38095238095238093, 1.0 ] }, "ic025": { "auc": 0.78, "ci": [ 0.38095238095238093, 1.0 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 3, "fp": 0, "fn": 2, "tn": 5, "sensitivity": 0.6, "specificity": 1.0, "ppv": 1.0 }, "eb05_ge_2": { "tp": 3, "fp": 0, "fn": 2, "tn": 5, "sensitivity": 0.6, "specificity": 1.0, "ppv": 1.0 }, "ic025_gt_0": { "tp": 4, "fp": 2, "fn": 1, "tn": 3, "sensitivity": 0.8, "specificity": 0.6, "ppv": 0.6666666666666666 }, "ror_lower_gt_1": { "tp": 4, "fp": 2, "fn": 1, "tn": 3, "sensitivity": 0.8, "specificity": 0.6, "ppv": 0.6666666666666666 } } }, { "subset": "outcome: bullous_eruptions_sjs_ten", "n": 10, "n_pos": 5, "n_neg": 5, "coverage": 1.0, "drug_matched": 1.0, "auc": { "prr": { "auc": 0.92, "ci": [ 0.6666666666666666, 1.0 ] }, "prr_lo": { "auc": 0.96, "ci": [ 0.76, 1.0 ] }, "ror_lo": { "auc": 0.96, "ci": [ 0.76, 1.0 ] }, "ebgm": { "auc": 0.92, "ci": [ 0.6666666666666666, 1.0 ] }, "eb05": { "auc": 0.96, "ci": [ 0.76, 1.0 ] }, "ic025": { "auc": 0.96, "ci": [ 0.76, 1.0 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 5, "fp": 2, "fn": 0, "tn": 3, "sensitivity": 1.0, "specificity": 0.6, "ppv": 0.7142857142857143 }, "eb05_ge_2": { "tp": 5, "fp": 2, "fn": 0, "tn": 3, "sensitivity": 1.0, "specificity": 0.6, "ppv": 0.7142857142857143 }, "ic025_gt_0": { "tp": 5, "fp": 3, "fn": 0, "tn": 2, "sensitivity": 1.0, "specificity": 0.4, "ppv": 0.625 }, "ror_lower_gt_1": { "tp": 5, "fp": 3, "fn": 0, "tn": 2, "sensitivity": 1.0, "specificity": 0.4, "ppv": 0.625 } } }, { "subset": "outcome: neutropenia_agranulocytosis", "n": 10, "n_pos": 5, "n_neg": 5, "coverage": 0.7, "drug_matched": 0.7, "auc": { "prr": { "auc": 0.84, "ci": [ 0.47619047619047616, 1.0 ] }, "prr_lo": { "auc": 0.84, "ci": [ 0.47619047619047616, 1.0 ] }, "ror_lo": { "auc": 0.84, "ci": [ 0.47619047619047616, 1.0 ] }, "ebgm": { "auc": 0.84, "ci": [ 0.47619047619047616, 1.0 ] }, "eb05": { "auc": 0.84, "ci": [ 0.47619047619047616, 1.0 ] }, "ic025": { "auc": 0.84, "ci": [ 0.47619047619047616, 1.0 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 4, "fp": 0, "fn": 1, "tn": 5, "sensitivity": 0.8, "specificity": 1.0, "ppv": 1.0 }, "eb05_ge_2": { "tp": 3, "fp": 0, "fn": 2, "tn": 5, "sensitivity": 0.6, "specificity": 1.0, "ppv": 1.0 }, "ic025_gt_0": { "tp": 4, "fp": 3, "fn": 1, "tn": 2, "sensitivity": 0.8, "specificity": 0.4, "ppv": 0.5714285714285714 }, "ror_lower_gt_1": { "tp": 4, "fp": 3, "fn": 1, "tn": 2, "sensitivity": 0.8, "specificity": 0.4, "ppv": 0.5714285714285714 } } }, { "subset": "outcome: rhabdomyolysis", "n": 9, "n_pos": 4, "n_neg": 5, "coverage": 1.0, "drug_matched": 1.0, "auc": { "prr": { "auc": 1.0, "ci": [ 1.0, 1.0 ] }, "prr_lo": { "auc": 1.0, "ci": [ 1.0, 1.0 ] }, "ror_lo": { "auc": 1.0, "ci": [ 1.0, 1.0 ] }, "ebgm": { "auc": 1.0, "ci": [ 1.0, 1.0 ] }, "eb05": { "auc": 1.0, "ci": [ 1.0, 1.0 ] }, "ic025": { "auc": 1.0, "ci": [ 1.0, 1.0 ] } }, "thresholds": { "evans_prr2_chi4_n3": { "tp": 4, "fp": 2, "fn": 0, "tn": 3, "sensitivity": 1.0, "specificity": 0.6, "ppv": 0.6666666666666666 }, "eb05_ge_2": { "tp": 4, "fp": 2, "fn": 0, "tn": 3, "sensitivity": 1.0, "specificity": 0.6, "ppv": 0.6666666666666666 }, "ic025_gt_0": { "tp": 4, "fp": 3, "fn": 0, "tn": 2, "sensitivity": 1.0, "specificity": 0.4, "ppv": 0.5714285714285714 }, "ror_lower_gt_1": { "tp": 4, "fp": 3, "fn": 0, "tn": 2, "sensitivity": 1.0, "specificity": 0.4, "ppv": 0.5714285714285714 } } }, { "subset": "outcome: 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