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"PARAMCD.PP", "Name": "PARAMCD.PP", "NCI Codelist Code": null, "Data Type": "text", "Order": 5, "Term": "TMAX", "NCI Term Code": null, "Decoded Value": "TMAX" }, { "ID": "PARAMCD.PP", "Name": "PARAMCD.PP", "NCI Codelist Code": null, "Data Type": "text", "Order": 6, "Term": "LAMZHL", "NCI Term Code": null, "Decoded Value": "LAMZHL" }, { "ID": "PARAMCD.PP", "Name": "PARAMCD.PP", "NCI Codelist Code": null, "Data Type": "text", "Order": 7, "Term": "LAMZ", "NCI Term Code": null, "Decoded Value": "LAMZ" }, { "ID": "PARAMCD.PP", "Name": "PARAMCD.PP", "NCI Codelist Code": null, "Data Type": "text", "Order": 8, "Term": "LAMZNPT", "NCI Term Code": null, "Decoded Value": "LAMZNPT" }, { "ID": "PARAMCD.PP", "Name": "PARAMCD.PP", "NCI Codelist Code": null, "Data Type": "text", "Order": 9, "Term": "R2ADJ", "NCI Term Code": null, "Decoded Value": "R2ADJ" }, { "ID": "PARAMCD.PP", "Name": "PARAMCD.PP", "NCI Codelist Code": null, "Data Type": "text", "Order": 10, "Term": "LAMZLL", "NCI Term Code": null, "Decoded Value": "LAMZLL" }, { "ID": "PARAMCD.PP", "Name": "PARAMCD.PP", "NCI Codelist Code": null, "Data Type": "text", "Order": 11, "Term": "LAMZUL", "NCI Term Code": null, "Decoded Value": "LAMZUL" }, { "ID": "PARAMCD.PP", "Name": "PARAMCD.PP", "NCI Codelist Code": null, "Data Type": "text", "Order": 12, "Term": "TLST", "NCI Term Code": null, "Decoded Value": "TLST" }, { "ID": "PARAMCD.PP", "Name": "PARAMCD.PP", "NCI Codelist Code": null, "Data Type": "text", "Order": 13, "Term": "CLST", "NCI Term Code": null, "Decoded Value": "CLST" }, { "ID": "PKEXRSN", "Name": "PKEXRSN", "NCI Codelist Code": null, "Data Type": "text", "Order": 1, "Term": "EMESIS WITHIN 2 H OF DOSING", "NCI Term Code": null, "Decoded Value": "EMESIS WITHIN 2 H OF DOSING" }, { "ID": "PKEXRSN", "Name": "PKEXRSN", "NCI Codelist Code": null, "Data Type": "text", "Order": 2, "Term": "PRE-DOSE CONCENTRATION ABOVE 5% OF CMAX", "NCI Term Code": null, "Decoded Value": "PRE-DOSE CONCENTRATION ABOVE 5% OF CMAX" }, { "ID": "PKEXRSN", "Name": "PKEXRSN", "NCI Codelist Code": null, "Data Type": "text", "Order": 3, "Term": "AUC BELOW 5% OF GEOMETRIC MEAN AUC", "NCI Term Code": null, "Decoded Value": "AUC BELOW 5% OF GEOMETRIC MEAN AUC" }, { "ID": "NCAEXRSN", "Name": "NCAEXRSN", "NCI Codelist Code": null, "Data Type": "text", "Order": 1, "Term": "ADJUSTED R-SQUARED BELOW 0.90", "NCI Term Code": null, "Decoded Value": "ADJUSTED R-SQUARED BELOW 0.90" }, { "ID": "NCAEXRSN", "Name": "NCAEXRSN", "NCI Codelist Code": null, "Data Type": "text", "Order": 2, "Term": "AUC(0-INF) EXTRAPOLATED ABOVE 20%", "NCI Term Code": null, "Decoded Value": "AUC(0-INF) EXTRAPOLATED ABOVE 20%" }, { "ID": "SEV", "Name": "SEV", "NCI Codelist Code": null, "Data Type": "text", "Order": 1, "Term": "MILD", "NCI Term Code": null, "Decoded Value": "MILD" }, { "ID": "SEV", "Name": "SEV", "NCI Codelist Code": null, "Data Type": "text", "Order": 2, "Term": "MODERATE", "NCI Term Code": null, "Decoded Value": "MODERATE" }, { "ID": "SEV", "Name": "SEV", "NCI Codelist Code": null, "Data Type": "text", "Order": 3, "Term": "SEVERE", "NCI Term Code": null, "Decoded Value": "SEVERE" }, { "ID": "REL", "Name": "REL", "NCI Codelist Code": null, "Data Type": "text", "Order": 1, "Term": "RELATED", "NCI Term Code": null, "Decoded Value": "RELATED" }, { "ID": "REL", "Name": "REL", "NCI Codelist Code": null, "Data Type": "text", "Order": 2, "Term": "NOT RELATED", "NCI Term Code": null, "Decoded Value": "NOT RELATED" } ], "Dictionaries": [ { "ID": "MEDDRA", "Name": "Adverse event dictionary", "Data Type": "text", "Dictionary": "MEDDRA", "Version": "28.1 (synthetic coding)" } ], "Methods": [ { "ID": "MT.TRTSEQP", "Name": "Algorithm for TRTSEQP", "Type": "Computation", "Description": "ADSL.TRTSEQP = DM.ARMCD (TR or RT, from the randomization schedule).", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.TRTXXP", "Name": "Algorithm for TRTXXP", "Type": "Computation", "Description": "TRT01P/TRT02P = first/second letter of TRTSEQP decoded (T = Test, R = Reference); TRTxxPN 1 = Test, 2 = Reference.", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.TRTSDTM", "Name": "Algorithm for TRTSDTM", "Type": "Computation", "Description": "First (last) EX record with EXDOSE > 0: EXSTDTC (EXENDTC) converted with admiral::derive_vars_dtm(); date part by derive_vars_dtm_to_dt().", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.TRTEDTM", "Name": "Algorithm for TRTEDTM", "Type": "Computation", "Description": "Last EX record with EXDOSE > 0, EXENDTC converted with admiral::derive_vars_dtm().", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.APXX", "Name": "Algorithm for APXX", "Type": "Computation", "Description": "admiral::derive_vars_period() from a period reference dataset built from EX: period xx starts at its dose (EXSTDTM) and ends one minute before the next dose, or at 23:59:59 on the end-of-study date; TRTxxA from EXTRT.", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.TRTSEQA", "Name": "Algorithm for TRTSEQA", "Type": "Computation", "Description": "First letters of TRT01A and TRT02A (T or R); one letter when only one period was dosed.", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.EOSSTT", "Name": "Algorithm for EOSSTT", "Type": "Computation", "Description": "From DS where DSCAT = DISPOSITION EVENT: COMPLETED if DSDECOD = COMPLETED, else DISCONTINUED; DCSREAS = DSDECOD when discontinued; EOSDT = DSSTDTC.", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.VSBL", "Name": "Algorithm for VSBL", "Type": "Computation", "Description": "VS.VSSTRESN at screening for VSTESTCD = HEIGHT (HEIGHTBL) and VSTESTCD = WEIGHT with VSBLFL = Y (WEIGHTBL).", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.BMIBL", "Name": "Algorithm for BMIBL", "Type": "Computation", "Description": "admiral::compute_bmi(HEIGHTBL, WEIGHTBL), rounded to 1 decimal.", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.AGEGR1", "Name": "Algorithm for AGEGR1", "Type": "Computation", "Description": "AGE < 30: 18-29 (1); AGE < 45: 30-44 (2); else 45-65 (3).", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.RANDFL", "Name": "Algorithm for RANDFL", "Type": "Computation", "Description": "Y if DS has DSDECOD = RANDOMIZED, else N (admiral::derive_var_merged_exist_flag()).", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.SAFFL", "Name": "Algorithm for SAFFL", "Type": "Computation", "Description": "Y if EX has a record with EXDOSE > 0, else N.", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.PKCFL", "Name": "Algorithm for PKCFL", "Type": "Computation", "Description": "Y if SAFFL = Y and ADPC has a quantifiable post-dose concentration (ANL01FL = Y, AVAL > 0, ARRLT > 0).", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.PKPFL", "Name": "Algorithm for PKPFL", "Type": "Computation", "Description": "Y if PKCFL = Y and ADPP has at least one period with ANL01FL = Y.", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.BEFL", "Name": "Algorithm for BEFL", "Type": "Computation", "Description": "Y if PKPFL = Y and ADPP has ANL01FL = Y periods for both Test and Reference (ICH M13A: evaluable data for both products).", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.APERIOD.PC", "Name": "Algorithm for APERIOD.PC", "Type": "Computation", "Description": "Period of the reference dose (PCRFTDTM); a pre-dose sample belongs to the dose that follows it.", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.TRTA.PC", "Name": "Algorithm for TRTA.PC", "Type": "Computation", "Description": "TRT01A or TRT02A for the record's APERIOD.", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.PARAMCD.PC", "Name": "Algorithm for PARAMCD.PC", "Type": "Computation", "Description": "PC.PCTESTCD for concentration records; DOSE for the dose records kept from EX (admiral ad_adpc.R).", "Expression Context": null, "Expression Code": null, "Document": null, "Pages": null }, { "ID": "MT.AVAL.PC", "Name": "Algorithm for AVAL.PC", "Type": "Computation", "Description": "PC.PCSTRESN; BLQ results (PCSTRESC =