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Annotated Trial DesignPersons using assistive technology may not be able to fully access information in this file. For assistance, e-mail niddk-cr@imsweb.com. Include the web site and filename in your message.Page 1 of 160DILINAnnotated Design For Trial: dilinProtocol: DILIN PROGenerated By InForm Architect April 20, 2012 S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 2 of 160Time and Events Schedule For Study: dilinAssessmentCRFScreening Visit Initial Study Visit MONTH6 Cross Active Study Termination MONTH 12 MONTH 24 Conflict onflict)(AUX)[S][S][S][S][S][ S/D ][ S/D ][ S/D ][ U/R/D ]1VISIT STATUSVISSTAT12DEMOGRAPHICSDEMOG23FAMILY HISTORYFAMHX134FAMILY HISTORY 2FAMHX24-RF-DF5PAST MEDICAL HISTORYMEDHX256PAST MEDICAL HISTORYMEDHX17PAST ALLERGY HISTORY8PAST SURGICAL HISTORY9PAST MEDICAL HISTORY-LIVER F5-RF-DFLIVHX9-RF-DF6-RF-DF6-RF-DF6-RF-DF10 GENERAL MEDICATION COMPLIANCERXCOMPLY1011 DRUG SPECIFIC MEDICATION COMPLIANCEDRUGCOMP11-RF12 QUESTIONNAIRESQUESTS1213 SOURCE OF RX MEDICATIONSPHARMACY13-DF14 GENERAL SMOKING HISTORY11GENSMOKE14-DF15 SMOKING HISTORYSMOKEHX15-RF-DF33-RF-DF32-RF-DF32-RF-DF16 SKINNER ALCOHOL 17 SYMPTOMSSAQSYMPT1730292918 RAND 36 HEALTH SURVEYRANDHS118-DF35-DF34-DF34-DF19 RAND 36 HEALTH SURVEY 2RANDHS219-DF36-DF35-DF35-DF20 RAND 36 HEALTH SURVEY 3RANDHS320-DF37-DF36-DF36-DF21 PEDIATRIC QUALITY OF LIFE INVENTORYPEDSQL121-DF38-DF37-DF37-DF22 PEDIATRIC QUALITY OF LIFE INVENTORY 2PEDSQL222-DF39-DF38-DF38-DF23 PEDIATRIC QUALITY OF LIFE INVENTORY 3PEDSQL323-DF40-DF39-DF39-DF24 PEDIATRIC QUALITY OF LIFE INVENTORY 4PEDSQL424-DF41-DF40-DF40-DF25 PEDIATRIC QUALITY OF LIFE INVENTORY 5PEDSQL525-DF42-DF41-DF41-DF26 PEDIATRIC QUALITY OF LIFE INVENTORY 6PEDSQL626-DF43-DF42-DF42-DF27 PEDIATRIC QUALITY OF LIFE INVENTORY 7PEDSQL727-DF44-DF43-DF43-DF28 PEDIATRIC QUALITY OF LIFE INVENTORY RF-DF11-RF-DF13-RF-DF13-RF-DF13-RF-DF29 HISTORY OF INJURY30 HISTORY OF INJURY 2HXINJ23031 HISTORY OF INJURY 3HXINJ331-RF-DF32 SIGNS AND SYMPTOMSSIGN32-RFDILIMED33-RF-DF34 CAMMEDCAMMED134-RF-DF35 LIVER TEST FLOW CHARTLABFLOW35-RF36 STANDARD LABS (w/in 4wks prior to ONSET)STDLABHX3637 STANDARD LAB FLOW CHART33 IMPLICATED DILI MEDICATIONSTDFLOW37-RF38 IMAGING STUDIESIMAGE38-RF-DF39 HEPATITIS STATUSHEPSTAT3940 HBeAG FLOW CHARTHBEAG40-RF-DF16-RF-DF41 Anti-HBe FLOW CHARTANTIHBE41-RF-DF17-RF-DF42 Anti-HDV (total) FLOW CHARTANTIHDV42-RF-DF43 HBV DNA FLOW CHARTHBVDNA43-RF-DF18-RF-DF44 HCV RNA FLOW CHARTHCVRNA44-RF-DF19-RF-DF45 HIV STATUSHIVSTAT4546 HIV STATUSHIVSTAT146-DF47 HIV STATUS DF23-RF-DF21-RF-DF21-RF-DF48 CD4 FLOW CHARThttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 3 of 16049 HIV RNA FLOW CHART24-RF-DF22-RF-DF22-RF-DF50 PHYSICAL EXAMHIVRNAPEX1225242451 PHYSICAL EXAM 2PEX2326252552 DIAGNOSTIC LABS 1DXLAB1453 DIAGNOSTIC LABS 2DXLAB2554 DIAGNOSTIC LABS 3DXLAB3655 STANDARD LABSSTDLAB727262656 STANDARD LABSSTDLAB28282727URINE9RSAMPLE1057 URINALYSIS58 RESEARCH SAMPLES49-RF-DF292828INTHX22260 ER/HOSPITAL/MED APPT HISTORYMEDHX377761 EMERGENCY ROOM VISITERRMHX8-RF-DF8-RF-DF8-RF-DF59 INTERVAL HISTORY/QUESTIONNAIRES62 HOSPITALIZATION VISITHOSPHX9-RF-DF9-RF-DF9-RF-DF63 MEDICAL APPOINTMENT HISTORYAPPTHIST10-RF-DF10-RF-DF10-RF-DF64 IMAGING STUDIESABDIMAGE121212MEDOUT14232366 INTERVAL HEPATITIS STATUSHEPSTATC1567 INTERVAL HIV STATUSHIVSTATC20181868 INTERVAL HIV STATUSHIVSTAT321-DF19-DF19-DF65 MAJOR MEDICAL OUTCOMES69 INTERVAL QUESTIONNAIRES70 INTERVAL GENERAL SMOKING HISTORY71 CHRONIC INCLUSION/EXCLUSION72 CONCOMITANT 46CONHX173 CONCOMITANT MEDICATIONSCONMED2-RF-DF74 CONCOMITANT CAM PRODUCTSCONCAM3-RF-DF75 HEPATITIS MEDICATIONS LOGHEPLOG4-RF-DF76 HIV MEDICATION LOGHIVLOG5-RF-DF77 BIOPSY COLLECTIONCOLLECT6-RF-DF78 ADVERSE EVENTSAE779 ADVERSE EVENTSAE18-RF-DF80 SERIOUS ADVERSE EVENTS81 RUCDR DNASAE9-RF-DFRUCDR10-RF-DF82 Fisher Repository BlooddrawNIDDKSER11-RF83 FISHER REPOSITORYNIDDKBPY12-RF-DF84 Serology FlowchartSEROFLOW13-RF-DF85 Protocol ExemptionPTLEXMPT14NARR1586 NARRATIVES87 EARLY WITHDRAWAL and STUDY COMPLETION88 INVESTIGATOR SIGNATURE89 Annual CONCOMITANT 5-RF-DF91 Annual CONCOMITANT CAM PRODUCTSACONCAM16-RF-DF16-RF-DF92 INTERVAL HEPATITIS STATUS 2HEPSTAT2171790 Annual CONCOMITANT MEDICATIONS93 Personal History QuestionnairePHXQ1194 Personal History QuestionnairePHXQ22-RF-DF95 Personal History QuestionnairePHXQ33-RF-DF96 Personal History QuestionnairePHXQ84-DF97 Personal History QuestionnairePHXQ12Key:[S] Scheduled VisitC Common Form5-DF[O] Optional VisitDF Dynamic Form[D] Dynamic VisitRF Repeating Form[U] Unscheduled Visit[R] Repeating Visithttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 0Page 4 of 1604/20/2012
Annotated Trial DesignPage 5 of 160dilin : Screening (SCR)Screening1.Birthdate2.SexReq/ Req/ Req(1910-2020) ][2]Female3.PI [read-only]A3 (dilincdd:SCR.INVSITE)4.Patient NumberA4(dilincdd:SCR.PATID)Inclusion Criteria5.Was the patient more than 2 years of age at the time of enrollment?(dilincdd:SCR.INEXC1)No[0][1]6.Did the patient have evidence of liver injury that is known or suspected to be related to a drug product or to a CAM product in the 6 months prior to enrollment?(dilincdd:SCR.INEXC2)No[0][1]7.Was the patient/legal guardian willing to sign informed consent?If ALT, AST, or AP was normal prior to the implicated drug start date, was ALT or AST 5 ULN or AP 2 ULN on at least 2 consecutive blood incdd:SCR.INEXC4)No[0][1]Yes (dilincdd:SCR.INEXC4A)If Yes, was ALT 5 ULN on at least 2 consecutive blood draws?[0][1]NoYes(dilincdd:SCR.INEXC4B)If Yes, was AST 5 ULN on at least 2 consecutive blood draws?[0][1]NoYes(dilincdd:SCR.INEXC4C)If Yes, was AP 2 ULN on at least 2 consecutive blood draws?[0][1]9.If ALT, AST, or AP was elevated prior to the implicated drug start date, was ALT or AST 5 pre-drug average or AP 2 pre-drug average on at least 2 consecutive blood draws?NoYes(dilincdd:SCR.INEXC5)No[0][1]Yes (dilincdd:SCR.INEXC5A)If Yes,was ALT 5 pre-drug average on at least 2 consecutive blood draws?[0][1]NoYes(dilincdd:SCR.INEXC5B)If Yes, was AST 5 pre-drug average on at least 2 consecutive blood draws?[0][1]NoYes(dilincdd:SCR.INEXC5C)If Yes, was AP 2 pre-drug average on at least 2 consecutive blood draws?[0][1]10.Did the patient have any elevation of serum ALT, AST, or AP above the ULN, associated with increased serum total bilirubin ( 2.5 mg/dL), absent of prior diagnosis of liver disease, Gilberts syndrome,or evidence of hemolysis?NoYes(dilincdd:SCR.INEX6A)No[0][1]Yes (dilincdd:SCR.INEXA6A)If Yes Specify ALT above the ULN[0][1]NoYes(dilincdd:SCR.INEXA6B)If Yes Specify AST above the ULN[0][1]NoYes(dilincdd:SCR.INEXA6C)If Yes Specify AP above the S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 0No4/20/2012
Annotated Trial DesignPage 6 of 160[1]11.Did the patient have any elevation of serum ALT, AST, or AP above the ULN, associated with coagulopathy with INR 1.5, absent of coumadin therapy or known vitamin K deficiency?Yes(dilincdd:SCR.INEX6B)No[0][1]Yes (dilincdd:SCR.INEXB6A)If Yes Specify ALT above the ULN[0][1]NoYes(dilincdd:SCR.INEXB6B)If Yes Specify AST above the ULN[0][1]NoYes(dilincdd:SCR.INEXB6C)If Yes Specify AP above the ULN[0][1]NoYesExclusion Criteria12.Did the patient have a competing identifiable cause of acute liver injury (e.g., hepatic ischemia) that was felt to be the primary reason for the observed liver injury, supported by laboratory test,serologies, liver biopsy, or radiology?13.Did the patient have a known, pre-existing liver problem that may confound the ability to make a diagnosis of DILI? (e.g. autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis,other chronic biliary tract disease)14.Did the patient have acetaminophen hepatotoxicity?15.Did the patient have a liver or allogeneic bone marrow transplant prior to the development of drug- or CAM-induced * ICF: Patient agrees to contribute biological samples and associated data and allow medical information to be used in this study and for future research related to liver injury or liver disease (geneticresearch C11)No[0][1]17.*ICF: In addition, patient agrees that biological specimens and associated data collected can be used for future research for conditions including but not limited to heart disease, cancer or mental illness(genetic research ILE)Satisfied all SCR.INEXC12)No[0]Entered per protocol exemptionItem is not requiredItem Design Notes:Item No.Design Note1.mapped from Screening form to Demographics formCDD: dilincddTable: SCRKey Type: PATIENTVISITColumn NameColumn Data TypeINEXC2NUMERICINVSITESTRING(3) - ATE - DDMONYYYYINEXC10NUMERICDesign Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial ATIDSTRING(4) - s.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 0Page 7 of 1604/20/2012
Annotated Trial DesignPage 8 of 160dilin : Enrollment (ENR).1. Patient Number2. Enrolled DateCDD: dilincddReqTable: ENR(dilincdd:ENR.SUBJNO)A15/ Req/ Req(2004-2020) (dilincdd:ENR.SCRNDT)Key Type: PATIENTVISITColumn NameColumn Data TypeSUBJNOSTRING(15) - A15SCRNDTDATE - DDMONYYYYDesign Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 9 of 160dilin : VISIT STATUS (VISSTAT).1. Date of visitReq2. Did the patient complete the visit?/ Req/ Req(2004-2020) No[0][1]YesIf patient withdrew early or completed all expected visits, please complete the termination visit.CDD: dilincddTable: VISSTATKey Type: PATIENTVISITColumn NameColumn Data TypeSAQDTDATE - DDMONYYYYCOMPVSTNUMERICDesign Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 10 of 160dilin : DEMOGRAPHICS (DEMOG)Patient Information****WARNING: ANY CHANGES MADE TO THE PATIENT INFORMATION FIELDS BELOW WILL CHANGE THE INDENTIFICATION OF THIS SUBJECT. Changes that make these fields empty will not be acted upon and the prior values will remain for the purpose of identification.***1.Patient q/ Req/ Req(1910-2020) 2]FemaleDemographics4.Do you consider yourself Hispanic, Latino, or :DEMOG.LATINORG)If Yes What is your Hispanic, Latino, or Latina origin[1][2][3][98]CubanMexicanPuerto RicanOtherOther Specify5.What is your race? (Check all that HITE)White[1](dilincdd:DEMOG.BLACK)Black or African :DEMOG.INDIAN)American Indian or Alaska Native[1](dilincdd:DEMOG.NATIVE)Native Hawaiian or Other Pacific Islander[1](dilincdd:DEMOG.RACEOTHR)[1]Other RaceOther Race (specify)6.In what country were you born(dilincdd:DEMOG.BIRTHCTY)Continental U.S., Alaska, or Hawaii[1][98]OtherSpecify Other Country7.Geographic area of residence StatePulldown List 18.Geographic area of residence CountyGeographic area of residence Zip Code10.Education (highest level completed)11.Marital statusHealth insurance IP)A10Pulldown List ingle[1]MarriedWidowedDivorcedSeparatedNot DEMOG.GEOSTATE)Specify other dicareMedicaid/Medicaid HMOPrivate and MedicareMedicare and Medicaidxxxxxxxx. nt/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 11 of 16013.* Data Entry Reviewed (MIGRATION TEAM USE ONLY)(dilincdd:DEMOG.DEMIGRAT)Yes[1]14.* Queries Reviewed (MIGRATION TEAM USE ONLY)(dilincdd:DEMOG.DMMIGRAT)Yes[1]*Item is not requiredItem Design Notes:Item No.Design Note2.mapped from Screening form to Demographics formPulldown List 1:RefNameDisplay TextieUSAlabamaAlabamaValue Design ka27ieUSNevadaNevada28ieUSNewHampsNew Hampshire29ieUSNewJerseyNew Jersey30ieUSNewMexicoNew Mexico31ieUSNewYorkNew York32ieUSNorthCarolina North Carolina33ieUSNorthDakotaNorth minf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignieUSRhodeIslandPage 12 of 160Rhode Island39ieUSSouthCarolina South Carolina40ieUSSouthDakotaSouth ia46ieUSWashingtonWashington47ieUSWestVirginiaWest ng50ieUSOTHOther98Pulldown List 2:RefNameDisplay TextieEDUNANot applicable (preschool age)Value Design Note1ieEDU8Elementary school (0 - 8th grade)2ieEDU11gr9 - 11th grade3ieEDU12g12th grade (or GED)4ieEDUADSome college/Associate's degree5ieEDUColleCollege degree6ieEDUPosGra Postgraduate degreeCDD: dilincddTable: DEMOG7Key Type: PATIENTVISITColumn Name Column Data RING(50) - A50EDUCATENUMERIC - 1, 2, 3, 4, 5, 6, ING(15) - A15DMMIGRATNUMERICWHITENUMERICORGINSPSTRING(50) - A50AGECALCFLOAT - F9.0GEOSTATENUMERIC - 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 98INSURANCNUMERICNATIVENUMERICRACESPSTRING(50) - A50BLACKNUMERICDOBDTDATE - ERICBRCTRYSPSTRING(50) - A50GEOZIPSTRING(10) - A10GEOCTYSTRING(50) - A50http://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 0Design Note4/20/2012
Annotated Trial S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 0Page 13 of 1604/20/2012
Annotated Trial DesignPage 14 of 160dilin : FAMILY HISTORY (FAMHX1)Family History1.Is your biological mother still (dilincdd:FAMHX1.MOMPHLTH)If Yes, what is her current health status[1][2][3][99]2.Is your biological father still 0][99][1]UnknownYes(dilincdd:FAMHX1.DADPHLTH)If Yes, what is his current health status[1][2][3][99]3.Are you a twin or one of a multiple 0][1]Yes(dilincdd:FAMHX1.TWINIDNT)Are you identical?[0][1][99]4.How many biological brothers do you have?5.How many biological sisters do you have?6.How many of your biological siblings are still alive?7.How many biological male children do you have?8.How many biological female children do you have?9.How many of your biological children are still alive?NoneNone(dilincdd:FAMHX1.SIBNA)[1]xxx MCNONE)[1]xxx NONE)[1]xxx ILDNA)[1]xxx ALLERGY)No[0][1][99][96]Table: FAMHX1Unknown(dilincdd:FAMHX1.SISNONE)[1]xxx (dilincdd:FAMHX1.SIS)[0]CDD: dilincddYes(dilincdd:FAMHX1.BRONONE)[1]xxx (dilincdd:FAMHX1.BRO)[0]10. Have any of your biological relatives ever suffered a drug allergy due to taking any medications that were severe enough to require a visit to a health care professional?NoYesUnknownNot applicableKey Type: PATIENTVISITColumn NameColumn Data TypeSIBNANUMERICDesign Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignMCNONENUMERICBRONUMERIC - N3MOMPHLTHNUMERICDADNUMERICSISNUMERIC - N3FCNONENUMERICTWINIDNTNUMERICMCHILDNUMERIC - N3TWINNUMERICFALLERGYNUMERICCHALIVENUMERIC - N3SIBALIVENUMERIC - N3CHILDNANUMERICFCHILDNUMERIC - MERIChttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 0Page 15 of 1604/20/2012
Annotated Trial DesignPage 16 of 160dilin : FAMILY HISTORY 2 (FAMHX2) - Repeating Form#Biological relativeDrug nameType of Reaction1Family History continued1. Biological 4]2. Drug nameSiblingChildren(dilincdd:FAMHX2.FDRGNM)A803. Type of ]CDD: dilincddMotherTable: FAMHX2Column Data TypeFDRGNMSTRING(80) - A80NUMERICDRGRACTNUMERICUnknownKey Type: PATIENTVISITColumn NameRELALLGYLiver ProblemDesign Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 17 of 160dilin : PAST MEDICAL HISTORY (MEDHX2)Past Medical History continued1.Does the subject have a history of medical conditions/diseases?2.Does the subject have a history of medical conditions-liver specific?3.Does the subject have a history of allergies to medications?4.Does the subject have a history of DHX2.SURGERY)No[0][1]Were any imaging studies s(dilincdd:MEDHX2.LIVHXYN)No[0]Was the PHQ lincdd:MEDHX2.PHQCOMP)PHQ completed by[1][98]*SubjectOtherItem is not requiredCDD: dilincddTable: MEDHX2Key Type: PATIENTVISITColumn NameColumn Data Design Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 18 of 160dilin : PAST MEDICAL HISTORY (MEDHX1) - Repeating Form#Name of System/DiseaseSpecify conditionDate of DiagnosisActive condition1Past Medical History1.Name of System/DiseasePulldown List 1A1003.Date of DiagnosisReq/Unk4.Active condition/ Req(1935-2020) CONDITN)2.* Specify conditionYesItem is not requiredPulldown List 1:RefNameDisplay TextieMHXDIABETESDiabetes/endocrine disorderValue Design Note1ieMHXINFECTIOUSInfectious disease2ieMHXPSYCHIATRICPsychiatric disease3ieMHXNEURONeurological disease4ieMHXHEARTHeart nal disease7ieMHXPULMONARYPulmonary disease8ieMHXGASTROGastrointestinal Autoimmune/collagen vascular disease11ieMHXCONGESTIVECongestive heart CTIVEReproductive issues14ieMHXORGANTRANSPOrgan transplantation (other than liver)15ieMHXACUTEHYPOTENSION Acute hypotension (one week prior to DILI onset)16ieMHXACUTECONGESTIVEAcute congestive heart failure (one week prior to DILI onset)17ieMHXOTHEROther (specify)98CDD: dilincddTable: MEDHX1Key Type: PATIENTVISITColumn Name Column Data TypePASTHXDTDesign NoteDATE - MONYYYYACTIVENUMERICCONDITNSTRING(100) - A100PASTHXNUMERIC - 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 98http://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 19 of 160dilin : PAST ALLERGY HISTORY (ALLRGYHX) - Repeating Form#AgentReaction1Past Allergy History1. AgentA802. ReactionCDD: dilincddA200Table: X.ALLGREAC)Key Type: PATIENTVISITColumn NameColumn Data TypeALLGREACSTRING(200) - A200AGENTSTRING(80) - A80Design Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 20 of 160dilin : PAST SURGICAL HISTORY (SURGHX) - Repeating Form#Specify surgeryDate of surgery1Past Surgical History1. Specify surgery2. Date of surgeryCDD: dilincdd(dilincdd:SURGHX.SXTYPE)A200Req/UnkTable: SURGHX/ Req/Unk/ Req(1935-2020) (dilincdd:SURGHX.SXDT)Key Type: PATIENTVISITColumn NameColumn Data TypeSXDTDATE - DDMONYYYYSXTYPESTRING(200) - A200Design Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 21 of 160dilin : PAST MEDICAL HISTORY-LIVER SPECIFIC (LIVHX) - Repeating Form#Type of Liver DiseaseDate of DiagnosisActive condition1NOTE-At initial study, only record chronic HCV & HBV. At follow up visits, only record acute/newly diagnosed HCV & HBVPast Med History-Liver Specific1. Type of Liver Disease(dilincdd:LIVHX.MEDLIVHX)Pulldown List 1If Family History is checked, please specify condition (dilincdd:LIVHX.LCONDITN)A2002. Date of DiagnosisReq/Unk3. Active condition/ Req(1935-2020) [0][1]YesPulldown List 1:RefNameDisplay TextieLIVHCVHCVValue Design Note1ieLIVHBVHBV2ieLIVALCOHOLAlcohol-related liver disease3ieLIVNONALCOHONon-alcoholic fatty liver disease (NALFD/NASH)4ieLIVWILSONWilson's rimary biliary cirrhosis7ieLIVPRIMSCPrimary sclerosing cholangitis8ieLIVGILBERTGilbert's syndrome9ieLIVA1ATA1AT deficiencyieLIVUNEXPALTUnexplained abnormal liver SCHHEPATIschemic hepatitis13ieLIVLIVERTRANLiver transplantation14ieLIVHEPATAHepatitis A1015ieLIVAUTOIMMUHEPAT Autoimmune hepatitis16ieLIVFHLD17CDD: dilincddFamily history of liver diseaseTable: LIVHXKey Type: PATIENTVISITColumn Name Column Data TypeMEDLIVHXDesign NoteNUMERIC - 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17LIVHXDTDATE - MONYYYYLCONDITNSTRING(200) - in/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 22 of 160dilin : GENERAL MEDICATION COMPLIANCE (RXCOMPLY)General Medication Compliance1. Surrogate ilincdd:RXCOMPLY.SURSPEC1)Specify Surrogate[1][98]2. When a doctor prescribes a medication for you to take, how closely do you usually follow the medication schedule?Table: RXCOMPLYColumn Data ICFREQMORENUMERICAlwaysSome of the timeMost of the timeAlwaysSome of the timeMost of the timeAlwaysKey Type: PATIENTVISITColumn NameFREQLESSMost of the DD: dilincddSome of the . Sometimes, people take their medications less frequently than was prescribed. Do you ever do this with prescribed ][1][2][3]3. Sometimes, people take their medications more frequently than was prescribed. Do you ever do this with prescribed medications?RelativeDesign Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 23 of 160dilin : DRUG SPECIFIC MEDICATION COMPLIANCE (DRUGCOMP) - Repeating Form#Surrogate respondentMedication nameFollow medication scheduleMore frequently than RXLess frequently than RXMore medications than RXLess medications than RX1Drug Specific Medication Compliance1. Surrogate ilincdd:DRUGCOMP.SURSPEC2)Specify Surrogate[1][98]2. Now, I'd like you to think about your medication schedule with3. How closely did you follow your medication schedule?Table: DRUGCOMPColumn Data ING(80) - C2NUMERICSome of the timeMost of the timeAlwaysSome of the timeMost of the timeAlwaysSome of the timeMost of the timeAlways(dilincdd:DRUGCOMP.RXLESTHN)NeverSome of the timeMost of the timeAlwaysKey Type: PATIENTVISITColumn 0][0][1][2][3]CDD: dilincddMost of the time(dilincdd:DRUGCOMP.RXLESS)Never[0][1][2][3]7. Sometimes, when people take their medications, they take less than they are supposed to. Did you ever take less of this medication than you were supposed to?Some of the time(dilincdd:DRUGCOMP.RXMORE)Never[0][1][2][3]6. Sometimes, when people take their medications, they take more than they are supposed to. Did you ever take more of this medication than you were supposed FOLLOW)Never[1][2][3]5. Did you ever take this medication less frequently than was prescribed?OtherA80[0][1][2][3]4. Did you ever take this medication more frequently than was prescribed?RelativeDesign Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 24 of 160dilin : QUESTIONNAIRES (QUESTS)Questionnaires1. Surrogate incdd:QUESTS.SURSPEC3)Specify Surrogate[1][98]2. During the last 12 months, did you fill a prescription for a medicine that was prescribed for you?Other(dilincdd:QUESTS.FILLRX)No[0][1]3. Over the past 5 years, how would you describe your smoking habit?RelativeYes(dilincdd:QUESTS.SMOKE)Never smoked[1][3][2]Current smokerEx-smokerHow many years since you quit smoking?4. Over the past 5 years, have you ever had at least one drink of alcohol, beer, liquor, wine, or wine coolers, per month during a 12-month time period, or at least threedrinks per day for at least three consecutive days (over a regular period of time)?(dilincdd:QUESTS.ALCOHOL)No[0][1]CDD: dilincddTable: QUESTSColumn Data TypeFILLRXNUMERICNUMERICQUITSMKEFLOAT - F9.0SURRO3NUMERICSURSPEC3NUMERICSMOKENUMERICYesKey Type: PATIENTVISITColumn NameALCOHOLxxxxxxxx. (dilincdd:QUESTS.QUITSMKE)Design Notehttp://vminf46dev03.dcri.int/dilin/pfts.dll?S 715d78c0&C TM 169&FMID 0&FMRV 0&ISID 0&ITID 0&VM 2&TN dilin&SP &AS 59391&CP 65535&FP 0&RSV 04/20/2012
Annotated Trial DesignPage 25 of 160dilin : SOURCE OF RX MEDICATIONS (PHARMACY)Source of Prescription Medications1.Is there one pharmacy where you usually go to fill most of your 2.What is the name of the pharmacy you visited most recently to fill or refill a prescription?A503.Pharmacy AddressA504.Pharmacy CityA255.Pharmacy StateA56.Pharmacy ZipA107.Pharmacy Telephone NumberA138.During the last 12 months, which of the following types of pharmacies did you use to fill prescriptions for medicines that were prescribed for you (check all that L1)National pharmacy chain[1](dilincdd:PHARMACY.LOCAL1)Local independently owned pharmacy[1](dilincdd:PHARMACY.CLINIC)Hospital or clinic-based pharmacy[1](dilincdd:PHARMACY
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