BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofAdmission(ADMITDT): Re-Admission/HospitalizationForm (ADM) WebVersion:1.0;4.02;06-09-11 1.Dateofdischarge:(DISCHDT) (mm/dd/yyyy) 2.Patientdischargestatus:(DISCPTST) 1-Alive 2-Dead IfDead,aDeathForm mustbesubmited. 3.RecordPRIMARYdischargediagnosis:(PHSPREAS) *Specifyorgan:(ADM4SPEC) **Specifyother:(ADM1SPEC) 01-01-GVHD 02-02-Relapse/Progression 03-03-GraftFailure 04-04-Infection 05-05-FungalInfection? 4.Recordsecondarydischargediagnoses: a.gvhd:(reasgvhd) b.relapse/progression:(reasrlps) 1-Contributory ncontributory? 1-Contributory ncontributory c.graftfailure:(reasgf) 1-Contributory ncontributory d.infection:(reasinf) 1-Contributory ncontributory e.fever:(reasfvr) 1-Contributory ncontributory f.seizure:(reasszr) 1-Contributory ncontributory g.bleeding/hemorhage:(reasgibl) 1-Contributory ncontributory h.diarhea:(reasdrh) 1-Contributory ncontributory i.nausea/vomiting:(reasnv) 1-Contributory ncontributory j.organfailure:(reasorgf) 1-Contributory ncontributory Specifyorgan:(ADM3SPEC) k.trauma:(reastram) 1-Contributory ncontributory l.psychiatric:(reaspsyc) 1-Contributory ncontributory m.secondarymalignancy:(reasmalg) 1-Contributory ncontributory n.scheduledprocedure/treatment:(reasproc) 1-Contributory ncontributory o.thrombosis/thrombus/embolism:(reastrmb) 1-Contributory ncontributory p.other:(reasothr) Specifyother:(ADM2SPEC) 1-Contributory ncontributory 5.Recordre-admissioninstitution:(ADMCENTR) 1-1-OriginalTransplantCenter 2-2-OtherTransplantCenter 3-3-OtherHospital Comments:(ADMCOMM1)
AdditionalSelectionOptionsforADM RecordPRIMARYdischargediagnosis: 06-06-Non-FungalInfection 07-07-Fever 08-08-Seizure 09-09-Bleeding/Hemorhage 10-10-Diarhea 11-11-Nausea/Vomiting 12-12-OrganFailure(specifyorgan)* 13-13-Trauma 14-14-Psychiatric 15-15-SecondaryMalignancy 16-16-Transplant 17-17-ScheduledProcedure/Treatment 18-18-Thrombosis/Thrombus/Embolism 99-99-Other(specify)**
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): Unexpected,Grade3-5AdverseEventForm (AE1) WebVersion:1.0;3.06;06-09-11 1.Reportactivationstatus:(AVSTATUS) IfOther,specifyreasonfordeactivation:(AESPEC1) 1-1-Keepreportactive 2-2-Deactivate-Reportfiledineror 3-3-Deactivate-Keyfielderor 9-9-Deactivate-Otherreason? 2.Recorddatetransplantcenterbecameawareoftheevent:(AVAWARDT) (mm/dd/yyyy) 3.Indicateweightattimeoftheevent:(AVWGHTKG) (xxx.x) kg 4.Wasthiseventexpectedoranticipated?(AVEXPECT) 5.Recordtheseverityofevent:(AVEVENT) 6.Whatistherelationshiptostudytherapy/intervention:(AVRELAT) 7.Isthereanalternativeetiology:(AVETIOL) 8.Whatistheefectonstudytherapy/interventionschedule:(AVEFFECT)? 1-1-Mild 2-2-Moderate 3-3-Severe 4-4-LifeThreatening 5-5-Fatal 1-1-Unrelated 2-2-Unlikely 3-3-Possible 4-4-Probable 5-5-Definite? 0-0-NoneApparent 1-1-StudyDisease 2-2-OtherPre-ExistingDiseaseorCondition 3-3-Accident,Trauma,orExternalFactors 4-4-ConcurentIlness/Condition(NotPre-Existing) 1-1-NoChange-Completed 2-Change-Ongoing 3-3-DoseModified 4-4-TemporarilyStopped 5-5-PermanentlyStopped 9.Recordthemostsevereoutcomeoftheevent:(AVOUTCOM) 1-1-Resolved,NoResidualEfects 2-2-ResolvedwithSequelae 3-3-PersistentCondition 4-4-ResolvedbyDeath 10.Recordthedateofresolution:(AVRESDT) (mm/dd/yyyy)? 11.Wasthiseventassociatedwith:(AVASSOCI) 0-0-NoneoftheFolowing 1-1-Death 2-2-Life-ThreateningEvent 3-3-Disability 4-4-CongenitalAnomaly??
Comments:(AE1COMM)
AdditionalSelectionOptionsforAE1 Wasthiseventassociatedwith: 5-5-RequiredInterventiontoPreventPermanentImpairmentorDamage 6-6-Hospitalization(InitialorProlonged) 9-9-OtherSAE
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): SummaryForm -Unexpected,Grade3-5AdverseEvent(AE2) WebVersion:1.0;3.06;06-09-11 1.Reportactivationstatus:(AVSTAT_A) 1-1-Keepreportactive 2-2-Deactivate-Reportfiledineror 3-3-Deactivate-Keyfielderor 9-9-Deactivate-Otherreason RelevantPastMedicalHistory 2.Doesthepatienthaveanyrelevanthistory,includingpre-existingmedical conditions?(semedhxs) IfYes,includeanyrelevanthistory,includingpreexistingmedicalconditionsbelow. (SEMEDHX) 3.EventSummary Includeclinicalhistoryofevent,associatedsignsandsymptoms,alternativeetiologiesbeingconsideredandmedicalmanagementbelow. (SESUMM) 4.Initialsubmiter:(SEISUBBY) Name: Date:(SEISUBDT) (mm/dd /yyyy) 5.Authorizedsubmiter:(SEASUBBY) Name: Date:(SEASUBDT) (mm/dd /yyyy)?
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): TherapyForm -Unexpected,Grade3-5AdverseEvent(AE3) WebVersion:1.0;3.06;06-09-11 1.Reportactivationstatus:(AVSTAT_B) 1-1-Keepreportactive 2-2-Deactivate-Reportfiledineror 3-3-Deactivate-Keyfielderor 9-9-Deactivate-Otherreason StudyProduct/SuspectMedicationData 2.Wasthepatientreceivinganystudyproducts/suspectmedications?(RCVSP) IfYes,listthestudyproduct/suspectmedicationsthesubjectwastakinginthegridbelow. StudyProductName (Note:Ifblinded,indicate assuch) Doseof StudyProduct(s) atsaeonset Routeof StudyProduct(s) atsae Onset Scheduleof StudyProduct(s) atsaeonset DateStudy Product FirstStarted (mm/dd/yyyy) DateStudy Product LastTaken (mm/dd/yyyy) ReasonforUse (SPNAME1) (SP1DOSE) (SP1ROUTE) (SP1SCHED) (SP1STDT) (SP1SPDT) (SP1REASO) (SPNAME2) (SP2DOSE) (SP2ROUTE) (SP2SCHED) (SP2STDT) (SP2SPDT) (SP2REASO) (SPNAME3) (SP3DOSE) (SP3ROUTE) (SP3SCHED) (SP3STDT) (SP3SPDT) (SP3REASO) (SPNAME4) (SP4DOSE) (SP4ROUTE) (SP4SCHED) (SP4STDT) (SP4SPDT) (SP4REASO) (SPNAME5) (SP5DOSE) (SP5ROUTE) (SP5SCHED) (SP5STDT) (SP5SPDT) (SP5REASO) ConcomitantMedications 3.Wasthepatienttakinganyconcomitantmedications?(RCVCONMD) IfYes,listtheconcomitantmedicationsthepatientwastakingupto1monthpriortoSAEonsetinthegridbelow. Medication StartDate (mm/dd/yyyy) StopDate (mm/dd/yyyy) Dose,Route,Schedule Indication (CONMED1) (CM1STDT) (CM1SPDT) (CM1DOSE) (CM1INDIC) 1-1-Treatmentofadverseevent 9-9-Other (CONMED2) (CM2STDT) (CM2SPDT) (CM2DOSE) (CM2INDIC) 1-1-Treatmentofadverseevent 9-9-Other (CONMED3) (CM3STDT) (CM3SPDT) (CM3DOSE) (CM3INDIC) 1-1-Treatmentofadverseevent 9-9-Other (CONMED4) (CM4STDT) (CM4SPDT) (CM4DOSE) (CM4INDIC) 1-1-Treatmentofadverseevent 9-9-Other (CONMED5) (CM5STDT) (CM5SPDT) (CM5DOSE) (CM5INDIC)
1-1-Treatmentofadverseevent 9-9-Other (CONMED6) (CM6STDT) (CM6SPDT) (CM6DOSE) (CM6INDIC) 1-1-Treatmentofadverseevent 9-9-Other (CONMED7) (CM7STDT) (CM7SPDT) (CM7DOSE) (CM7INDIC) 1-1-Treatmentofadverseevent 9-9-Other (CONMED8) (CM8STDT) (CM8SPDT) (CM8DOSE) (CM8INDIC) 1-1-Treatmentofadverseevent 9-9-Other (CONMED9) (CM9STDT) (CM9SPDT) (CM9DOSE) (CM9INDIC) 1-1-Treatmentofadverseevent 9-9-Other (CONMED10) (CM10STDT) (CM10SPDT) (CM10DOSE) (CM10INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED11) (CM11STDT) (CM11SPDT) (CM11DOSE) (CM11INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED12) (CM12STDT) (CM12SPDT) (CM12DOSE) (CM12INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED13) (CM13STDT) (CM13SPDT) (CM13DOSE) (CM13INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED14) (CM14STDT) (CM14SPDT) (CM14DOSE) (CM14INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED15) (CM15STDT) (CM15SPDT) (CM15DOSE) (CM15INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED16) (CM16STDT) (CM16SPDT) (CM16DOSE) (CM16INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED17) (CM17STDT) (CM17SPDT) (CM17DOSE) (CM17INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED18) (CM18STDT) (CM18SPDT) (CM18DOSE) (CM18INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED19) (CM19STDT) (CM19SPDT) (CM19DOSE) (CM19INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED20) (CM20STDT) (CM20SPDT) (CM20DOSE) (CM20INDI) 1-1-Treatmentofadverseevent 9-9-Other
(CONMED21) (CM21STDT) (CM21SPDT) (CM21DOSE) (CM21INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED22) (CM22STDT) (CM22SPDT) (CM22DOSE) (CM22INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED23) (CM23STDT) (CM23SPDT) (CM23DOSE) (CM23INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED24) (CM24STDT) (CM24SPDT) (CM24DOSE) (CM24INDI) 1-1-Treatmentofadverseevent 9-9-Other (CONMED25) (CM25STDT) (CM25SPDT) (CM25DOSE) (CM25INDI) 1-1-Treatmentofadverseevent 9-9-Other Comments:(AE3COMM)
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): Laboratory/DiagnosticsForm -Unexpected,Grade3-5AdverseEvent(AE4) WebVersion:1.0;3.05;06-09-11 1.Reportactivationstatus:(AVSTAT_C) 1-1-Keepreportactive 2-2-Deactivate-Reportfiledineror 3-3-Deactivate-Keyfielderor 9-9-Deactivate-Otherreason LaboratoryTestResults 2.Wererelevantlaboratorytestsperformed?(LABTSTPF) IfYes,recordtherelevantlaboratorytestresultsinthegirdbelow. Test ColectionDate (mm/dd/yyyy) Result (Includeunits) SiteNormal Range (Includeunits) LabValuePrevious tothissae (Includeunits) ColectionDate forpreviouslab (mm/dd/yyyy) (ADLTST1) (ADL1CD) (ADL1RES) (ADL1NORG) (ADL1PRVL) (ADL1PCD) (ADLTST2) (ADL2CD) (ADL2RES) (ADL2NORG) (ADL2PRVL) (ADL2PCD) (ADLTST3) (ADL3CD) (ADL3RES) (ADL3NORG) (ADL3PRVL) (ADL3PCD) (ADLTST4) (ADL4CD) (ADL4RES) (ADL4NORG) (ADL4PRVL) (ADL4PCD) (ADLTST5) (ADL5CD) (ADL5RES) (ADL5NORG) (ADL5PRVL) (ADL5PCD) (ADLTST6) (ADL6CD) (ADL6RES) (ADL6NORG) (ADL6PRVL) (ADL6PCD) (ADLTST7) (ADL7CD) (ADL7RES) (ADL7NORG) (ADL7PRVL) (ADL7PCD) (ADLTST8) (ADL8CD) (ADL8RES) (ADL8NORG) (ADL8PRVL) (ADL8PCD) (ADLTST9) (ADL9CD) (ADL9RES) (ADL9NORG) (ADL9PRVL) (ADL9PCD) (ADLTST10) (ADL10CD) (ADL10RES) (ADL10NRG) (ADL10PVL) (ADL10PCD) DiagnosticTests(EX:MR,CTScan,Ultrasound) 3.Wererelevantdiagnostictestsperformed?(DXSTPF) IfYes,recordtherelevantdiagnostictestresultsinthegridbelow.Submitcopiesofthediagnostictestifavailable. Test DatePerformed (mm/dd/yyyy) Results/Comments
(ADDTS1) (AD1DTDAT) (AD1DTRES) (ADDTS2) (AD2DTDAT) (AD2DTRES) (ADDTS3) (AD3DTDAT) (AD3DTRES) (ADDTS4) (AD4DTDAT) (AD4DTRES) (ADDTS5) (AD5DTDAT) (AD5DTRES)
(ADDTS6) (AD6DTDAT) (AD6DTRES) (ADDTS7) (AD7DTDAT) (AD7DTRES) (ADDTS8) (AD8DTDAT) (AD8DTRES) (ADDTS9) (AD9DTDAT) (AD9DTRES) (ADDTS10) (AD10DTDT) (AD10DTRS)
Comments:(AE4COMM)
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): Review Form -Unexpected,Grade3-5AdverseEvent(AE5) WebVersion:1.0;3.06;06-09-11 1.Reportactivationstatus:(AVSTAT_D) 1-1-Keepreportactive 2-2-Deactivate-Reportfiledineror 3-3-Deactivate-Keyfielderor 9-9-Deactivate-Otherreason 2.Reviewed:(AEREVIEW) 3.Reviewedby:(ARFREVBY) 4.Review date:(arfrevdt) (mm/dd/yyyy) 5.Comment1-ForDistribution:(ARCM1DIS) 6.Comment2-AlOtherReviewers/DataCoordinatingCenter(ARCM2ALL)
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): MedicalMonitorReviewerForm -Unexpected,Grade3-5AdverseEvent(AE6) WebVersion:1.0;5.00;10-14-11 1.Adverseeventstatus:(AVSTAT_E) 1-1-Keepreportactive 2-2-Deactivate-Reportfiledineror 3-3-Deactivate-Keyfielderor 9-9-Deactivate-Otherreason 2.Hasthiseventbeendeterminedtobeanunexpected,grade3-5adverse event?(amdeter) 3.DoesthisrequireexpeditedreportingtotheDSMB?(AMEXPDSM) 4.Doyourecommendthepatientbewithdrawnfrom furtherprotocol therapy?(amwithdr) 5.Isthereviewcomplete?(AMREVDNE) 6.IfNo,whatadditionalinformationisrequired:(AMREVINF) 7.MedicalMonitoreventdescription:(AMMMEVDS) Comments:(AE6COMM)
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): VisitNumber(VISNO): Folow UpGVHD Form (CGV) WebVersion:1.0;7.03;06-22-11 1.Startofassessmentperiod:(DTPRVAST) (mm/dd/yyyy) 2.Endofassessmentperiod:(DTASSESS) (mm/dd/yyyy) Answerquestions3-9relatingtoacuteGVHD. 3.Maximum overalgradeofacutegvhd duringthis assessmentperiod:(grdagvhd) 0-0-NoSymptomsofAcuteGVHD 1-1-I 2-2-I 3-3-I 4-4-IV 4.Didclinicalsignsand/orsymptomsofacuteGVHDdevelop duringthisassessmentperiod?(agvdvlp) 5.Recordmethodusedtodiagnoseacute GVHD:(DGNSAGVH)? 1-1-HistologicEvidence 2-2-ClinicalEvidence 3-3-Both 6.DateofdiagnosisofacuteGVHD:(DTDGNAGV) (mm/dd/yyyy)? 7.WasprophylaxisforGVHD givenduringthisassessment period?(prophimm) 1-2- 3-3-DiscontinuedDuringThisAssessmentPeriod 8.Ifyes,specifyalimmunosuppressantsusedforGVHD prophylaxis: a.cyclosporine:(prophcy) b.tacrolimus:(prophtac) c.sirolimus:(prophsir) d.mmf:(prophmmf) e.prednisone:(prophprd) f.other:(prophoth) Specifyotheragentused:(PRPHOTSP) 9.IfGVHD prophylaxiswasdiscontinuedduringthis assessment,recordthedate:(prphdisc) (mm/dd/yyyy) Answerquestions10-20relatingtochronicGVHD. 10.Maximum overalseverityofchronicgvhd duringthis assessmentperiod:(sevcgvhd) 0-0-NoSymptomsofChronicGVHD 1-1-Mild 2-2-Moderate 3-3-Severe 11.Maximum overalgradeofchronicgvhd duringthis assessmentperiod:(grdcgvhd) 12.Didclinicalsignsand/orsymptomsofchronicGVHD develop duringthisassessmentperiod?(cgvdvlp) 13.Recordmethodusedtodiagnosechronic GVHD:(DGNSCGVH) 1-Limited 2-Extensive?? 1-1-HistologicEvidence 2-2-ClinicalEvidence 3-3-Both 14.DateofdiagnosisofchronicGVHD:(DTDGNCGV) (mm/dd/yyyy)?
15.Minimum Karnofsky/LanskyScoreattimeof diagnosis:(cgvkrnln) 01-01-100(Normal;NoComplaints/FulyActive) 02-02-90(NormalActivity/MinorRestrictioninStrenuousPlay) 03-03-80(NormalActivitywithEfort/RestrictedinStrenuousPlay) 04-04-70(UnabletoCaryOnNormalActivity/LessTimeSpentinPlay) 05-05-60(RequiresOccasionalAssistance/MinimalActivePlay) 16.Minimum plateletcountattimeofdiagnosis:(pltltcnt) (xxx.x) x10 9 /L 17.Alkalinephosphataseattimeofdiagnosis:(ALKPHOSP) (xxxx) U/L 18.Weightattimeofdiagnosis:(CGVWEIGH) (xxx.x) kg 19.Totalbilirubinattimeofdiagnosis:(BILIRUBN) (xx.x) mg/dl 20.Bodysurfaceareainvolvedwithrashattimeof diagnosis:(bsa) (xxx) %? Indicatethemaximum severityofinvolvementforthefolowingorgansystemsduringthisassessment period. Skin/Hair 21.Extentofskininvolvement:(CGVRASH) 0-0-NoRash 1-1-<25% ofbsainvolvement 2-2-25-50% ofbsainvolvement 3-3->50% ofbsainvolvement 4-4-GeneralizedInvolvement Ifthereisskininvolvement,indicatethetypeofrash: a.lichenoid:(rashlich)? b.maculopapular:(rashmacu) c.sclerodermatous:(rashsclr) Ocular 22.Xerophthalmia:(DRYEYES) 0-0-NoSymptoms 1-1-DryEyesbutNotRequiringTherapy 2-2-DrynessofEyesorInflammationRequiringTherapy Oral 23.Mucositis/ulcers(functional):(MUCOFXN) 0-0-NoSymptoms 1-1-MinimalSymptoms,NormalDiet 2-2-SymptomaticbutCanEatandSwalowModifiedDiet 3-3-SymptomaticandUnabletoAdequatelyAlimentorHydrateOraly Pulmonary 24.Dyspnea:(CGVDYSPN) 0-0-Asymptomatic 1-1-DyspneawithExertion 2-2-DyspneawithNormalActivities 3-3-DyspneaatRest 25.Pulmonaryfibrosis:(PULMFIBR) 0-0-None 1-1-MinimalRadiographicFindings 2-2-PatchyorBi-basilarRadiographicFindings 3-3-ExtensiveRadiographicFindings 9-9-NotDone 26.Bronchiolitisobliterans:(BRNCOBLT) 1-,Histologicdiagnosis 2-2-Yes,Clinicaldiagnosis 3-3-No 4-4-Unknown 27.FEV1:(CGVFEV1) 0-0-100-90% 1-1-<90-75% 2-2-<75-50% 3-3-<50-25% 4-4-<25%
28.Oxygensaturation:(O2SAT) 0-0-NoSymptoms 1-1-DesaturationwithExercise 2-2-RequiresSupplementalOxygen Gastrointestinal 29.Esophagus:(ESOPHAGS) 0-0-NoChanges 1-1-SymptomaticbutCanEatRegularDiet 2-2-DysphagiaorOdynophagiaRequiringDietaryChanges 3-3-NeedforParenteralNutrition 30.Nauseaandvomiting:(NAUSVOMT) 0-0-NoProtractedNauseaandVomiting 1-1-PersistentNausea,VomitingorAnorexia 31.Diarhea:(CGVDIARH) 0-0-None 1-1-PersistingLessThan2Weeks 2-2-PersistingMoreThan2Weeks 32.Wasdiarheameasuredasnumberofstoolsorvolumeof stools?(diarhmsr) 1-1-NumberofStools 2-2-VolumeofStools 3-3-BothNumberandVolume 33.Diarhea(numberofstools):(DIARHEA1) 1-1-Increaseof<4Stools/dayOverBaseline;MildIncreaseinOstomyOutputComparedtoBaseline 2-2-Increaseof4-6stools/day;IVFluidsIndicated<24Hrs;ModerateIncreaseinOstomyOutput 3-3-Increaseof7orMoreStools/day,IVFluidsfor24orMoreHrs;Hospitalization 4-4-Life-threateningConsequences(e.g.HemodynamicColapse) 5-5-Death UsemL/dayforadultrecipientsandmL/m 2 forpediatricrecipients. 34.Diarhea(volumeofstools):(DIARHEA2) 1-1-DiarheaLessThanorEqualto500mL/dayor<280mL/m^2 2-2-Diarhea>500butLessThanorEqualto1000mL/dayor280-555mL/m^2 3-3-Diarhea>1000butLessThanorEqualto1500mL/dayor556-833mL/m^2 4-4-Diarhea>1500mL/dayor>833mL/m^2 5-5-SevereAbdominalPainwithorwithoutIleus,orStoolwithFrankBloodorMelena 35.Malabsorption:(MALABSRP) 0-0-NoSymptoms 2-2-AlteredDiet;OralTherapiesIndicated(e.g.Enzymes,Medications,DietarySupplements) 3-3-InabilitytoAlimentAdequatelyviaGITract(e.g.TPN Indicated) 4-4-Life-threateningConsequences 5-5-Death Hepatic 36.Bilirubinlevel:(LIVERBIL) 0-0-Bilirubin<2.0mg/dL 1-1-Bilirubin2.0-3.0mg/dL 2-2-Bilirubin3.1-6.0mg/dL 3-3-Bilirubin6.1-15.0mg/dL 4-4-Bilirubin>15.0mg/dL Genitourinary 37.Vaginitis:(VAGNITIS) 0-0-NoSymptomsorNotApplicable 1-1-Mild,InterventionNotIndicated 2-2-Moderate,InterventionIndicated 3-3-Severe,NotRelievedwithTreatment;Ulceration Musculoskeletal 38.Contractures:(CONTRCTR) 0-0-NoSymptoms 2-2-MildJointContractures(DoesnotAfectADL) 3-3-SevereJointContractures(InterfereswithADL) 39.Myositis:(MYOSITIS) Hematologic 40.Eosinophilia:(EOSINPHL)
Other 41.Serositis:(SEROSITS) 42.Fascitis:(FASCITIS) 43.Wasthereotherorganinvolvement?(ORGNOTHR) Specifyotherorgan:(ORGSPEC) Answerquestions44-50relatingtobiopsiesperformedduringthisassessmentperiod. 44.Wereanybiopsiesperformedduringthisassessmentperiod forsuspectedgvhd?(biopsy) Ifyes,recordthetype,date,andresultofanybiopsiesperformedforsuspectedGVHDbelow. TypeofBiopsy: IfOther,Specify: DateofBiopsy: ResultofBiopsy: 45.(BIOTYP1) 1-1-SkinBiopsy 2-2-OralBiopsy 3-3-UpperGIBiopsy 4-4-LowerGIBiopsy 5-5-LiverBiopsy (TYP1OSPE) (BIODT1) (mm/dd /yyyy) (BIORSLT1) 1-1-Positive 2-2-Negative 3-3-Equivocal 46.(BIOTYP2) 1-1-SkinBiopsy 2-2-OralBiopsy 3-3-UpperGIBiopsy 4-4-LowerGIBiopsy 5-5-LiverBiopsy (TYP2OSPE) (BIODT2) (mm/dd /yyyy) (BIORSLT2) 1-1-Positive 2-2-Negative 3-3-Equivocal 47.(BIOTYP3) 1-1-SkinBiopsy 2-2-OralBiopsy 3-3-UpperGIBiopsy 4-4-LowerGIBiopsy 5-5-LiverBiopsy (TYP3OSPE) (BIODT3) (mm/dd /yyyy) (BIORSLT3) 1-1-Positive 2-2-Negative 3-3-Equivocal 48.(BIOTYP4) 1-1-SkinBiopsy 2-2-OralBiopsy 3-3-UpperGIBiopsy 4-4-LowerGIBiopsy 5-5-LiverBiopsy (TYP4OSPE) (BIODT4) (mm/dd /yyyy) (BIORSLT4) 1-1-Positive 2-2-Negative 3-3-Equivocal 49.(BIOTYP5) 1-1-SkinBiopsy 2-2-OralBiopsy 3-3-UpperGIBiopsy 4-4-LowerGIBiopsy 5-5-LiverBiopsy (TYP5OSPE) (BIODT5) (mm/dd /yyyy) (BIORSLT5) 1-1-Positive 2-2-Negative 3-3-Equivocal 50.(BIOTYP6) 1-1-SkinBiopsy 2-2-OralBiopsy 3-3-UpperGIBiopsy 4-4-LowerGIBiopsy 5-5-LiverBiopsy (TYP6OSPE) (BIODT6) (mm/dd /yyyy) (BIORSLT6) 1-1-Positive 2-2-Negative 3-3-Equivocal Answerquestions51-54relatingtoGVHD therapy.
51.WasaspecifictherapyusedtotreatGVHD duringthis assessmentperiod?(thrpyusd) 1-,InitiatedthisAssessmentPeriod 2-2-Yes,Continuingfrom PreviousAssessmentPeriod 3-3-No? Ifyes,indicatewhetherornottheagentslistedbelowwereusedtotreatGVHD duringthisassessmentperiod: a.als,alg,ats,atg:(thrpyatg) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven b.azathioprine:(thrpyaza) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven c.cyclosporine:(thrpycyc) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven d.systemiccorticosteroids:(thrpysco) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven e.topicalcorticosteroids:(thrpytco) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven f.thalidomide:(thrpytha) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven g.tacrolimus(fk 506,Prograf):(THRPYTAC) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven h.mycophenolatemofetil(mmf,celcept):(thrpymmf) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven i.puva(psoralenanduva):(thrpypuv) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven j.ecp(extra-corporealphotopheresis):(thrpyecp) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven k.sirolimus(rapamycin):(thrpysir) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven l.etretinate:(thrpyetr) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven m.lamprene:(thrpylam) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven n.etanercept:(thrpyeta) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven o.zenapax(daclizumab):(thrpyzen) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven p.chloroquinephosphate:(thrpycph) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven
q.invivoantit-lymphocytemonoclonal Antibody:(THRPYMAB) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven SpecifyinvivoantiT-lymphocytemonoclonalantibody used:(mabagnt) r.invivoimmunotoxin:(thrpyimm) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven Specifyinvivoimmunotoxinused:(IMMAGNT) s.other:(thrpyoth) 1-,StilTakingDrug 2-2-Yes,NoLongerTakingDrug 3-3-No,DrugNotGiven Specifyotheragentused:(OTHAGNT) 52.Hastreatmentbeendiscontinued?(ONGTRT) 53.Ifyes,enterdateofdiscontinuation:(TRTSTOP) (mm/dd/yyyy) 54.IndicatethebestresponsetoGVHD therapyduringthis assessmentperiod:(thrpyrsp) 1-1-CompleteResolutionofSymptoms 2-2-PartialResolutionofSymptoms 3-3-StableSymptoms 4-4-ProgressionofSymptoms? Answerquestions55-58relatingtocurrentpatientstatus. 55.AresymptomsofGVHD stilpresent?(gvhdsymp) 56.CurentKarnofsky/LanskyScore:(CURKRNLN) 01-01-100(Normal;NoComplaints/FulyActive) 02-02-90(NormalActivity/MinorRestrictioninStrenuousPlay) 03-03-80(NormalActivitywithEfort/RestrictedinStrenuousPlay) 04-04-70(UnabletoCaryOnNormalActivity/LessTimeSpentinPlay) 05-05-60(RequiresOccasionalAssistance/MinimalActivePlay) 57.Curentplateletcount:(CURPLTCT) (xxx.x) x10 9 /L 58.Curentweight:(CURWGHT) (xxx.x) kg Comments:(CGVCOMM)
AdditionalSelectionOptionsforCGV Minimum Karnofsky/LanskyScoreattimeofdiagnosis: 06-06-50(RequiresConsiderableAssistance/NoActivePlay) 07-07-40(Disabled/AbletoInitiateQuietActivities) 08-08-30(SeverelyDisabled/NeedsAssistanceforQuietPlay) 09-09-20(VerySick/LimitedtoVeryPassiveActivity) 10-10-10(Moribund;CompletelyDisabled) BiopsyType1 6-6-LungBiopsy 7-7-Other,Specify CurentKarnofsky/LanskyScore: 06-06-50(RequiresConsiderableAssistance/NoActivePlay) 07-07-40(Disabled/AbletoInitiateQuietActivities) 08-08-30(SeverlyDisabled/NeedsAssistanceforQuietPlay) 09-09-20(VerySick/LimitedtoVeryPassiveActivity) 10-10-10(Moribund;CompletelyDisabled) 11-11-0(Dead)
BloodandMarrow TransplantClinical TrialsNetwork Demographics(DEM) WebVersion:1.0;6.00;06-22-11 1.NameCode:(NAMECODE) 2.IUBMID #(ifavailable):(iubmid) 3.CRID #(CIBMTRRecipientID):(CRIDNUM) (xxxxxxxxxx) 4.Gender:(GENDER) DoNOTuseIUBMID/UPN numbersinthecridfield. 1-Male 2-Female 5.DateofBirth:(DOB) (mm/dd/yyyy) 6.Ethnicity:(ETHNIC) 1-1-HispanicorLatino 2-tHispanicorLatino 8-8-Unknown 9-9-NotAnswered 7.Race:(RACE) -White 10-10-White(NotOtherwiseSpecified) 11-11-European(NotOtherwiseSpecified) 13-13-Mediteranean 14-14-WhiteNorthAmerican Specifyrace:(RACESP) 8.SecondaryRace:(RACE2) -White 10-10-White(NotOtherwiseSpecified) 11-11-European(NotOtherwiseSpecified) 13-13-Mediteranean 14-14-WhiteNorthAmerican Specifysecondaryrace:(RACE2SP) Comments:(DEMCOMM1)
AdditionalSelectionOptionsforDEM Race: 15-15-SouthorCentralAmerican 16-16-EasternEuropean 17-17-NorthernEuropean 18-18-WesternEuropean 81-81-WhiteCaribbean 82-8rthCoastofAfrica 83-83-MiddleEastern -Black 20-20-Black(NotOtherwiseSpecified) 21-21-AfricanAmerican 22-22-AfricanBlack(BothParentsBorninAfrica) 23-23-CaribbeanBlack 24-24-SouthorCentralAmericanBlack 29-29-Black,OtherSpecify -Asian 30-30-Asian(NotOtherwiseSpecified) 31-31-Indian/SouthAsian 32-32-Filipino(Pilipino) 34-34-Japanese 35-35-Korean 36-36-Chinese 37-37-OtherSoutheastAsian 38-38-Vietnamese -AmericanIndianorAlaskaNative 50-50-NativeAmerican(NotOtherwiseSpecified) 51-51-NativeAlaskan/Eskimo/Aleut 52-52-AmericanIndian(NotOtherwiseSpecified) 53-53-NorthAmericanIndian 54-54-SouthorCentralAmericanIndian 55-55-CaribbeanIndian -NativeHawaianorOtherPacificIslander 60-60-NativePacificIslander(NotOtherwiseSpecified) 61-61-Guamanian 62-62-Hawaian 63-63-Samoan -Other 88-88-Unknown 90-90-Other,Specify 99-99-NotAnswered
BloodandMarrow TransplantClinical TrialsNetwork DeathForm (DTH) WebVersion:1.0;4.06;06-22-11 1.Recorddateofdeath:(DTHDT) (mm/dd/yyyy) 2.Wasanautopsyperformed?(AUTPERF) Ifyes,submitautopsyreporttoDCC Enterappropriatecauseofdeathcodebelow.Listinorderofdecreasingseverity. 3.Primarycauseofdeath:(CZDTHPRM) 1.0-1.0-GraftRejectionorFailure -Infection(OtherthanInterstitialPneumonia) 1.1-1.1-AutologousRecovery 1.2-1.2-Rejection 2.1-2.1-Bacterial? Specifyother:(DTHSPEC1) 4.Secondarycauseofdeath:(SCNDCZ1) 1.0-1.0-GraftRejectionorFailure -Infection(OtherthanInterstitialPneumonia) 1.1-1.1-AutologousRecovery 1.2-1.2-Rejection 2.1-2.1-Bacterial Specifyother:(DTHSPEC2) 5.Secondarycauseofdeath:(SCNDCZ2) 1.0-1.0-GraftRejectionorFailure -Infection(OtherthanInterstitialPneumonia) 1.1-1.1-AutologousRecovery 1.2-1.2-Rejection 2.1-2.1-Bacterial Specifyother:(DTHSPEC3) 6.Secondarycauseofdeath:(SCNDCZ3) 1.0-1.0-GraftRejectionorFailure -Infection(OtherthanInterstitialPneumonia) 1.1-1.1-AutologousRecovery 1.2-1.2-Rejection 2.1-2.1-Bacterial Specifyother:(DTHSPEC4) 7.Secondarycauseofdeath:(SCNDCZ4) 1.0-1.0-GraftRejectionorFailure -Infection(OtherthanInterstitialPneumonia) 1.1-1.1-AutologousRecovery 1.2-1.2-Rejection 2.1-2.1-Bacterial Specifyother:(DTHSPEC5) Comments:(DTCMMNTS)
AdditionalSelectionOptionsforDTH Primarycauseofdeath: 2.2-2.2-Fungal 2.3-2.3-Viral 2.4-2.4-Protozoal 2.5-2.5-Other,SpecifyBelow 2.9-2.9-Organism NotIdentified -InterstitialPneumonia 3.1-3.1-Viral,CMV 3.2-3.2-Viral,Other 3.3-3.3-Pneumocystis 3.4-3.4-Other,SpecifyBelow 3.9-3.9-Idiopathic 4.0-4.0-AdultRespiratoryDistressSyndrome 5.0-5.0-AcuteGVHD 6.0-6.0-ChronicGVHD 7.0-7.0-RecurenceorPersistenceofLeukemia/Malignancy/MDS 7.1-7.1-PersistentDisease -OrganFailure(NotDuetoGVHDorInfection) 8.1-8.1-Liver 8.2-8.2-Cardiac(Cardiomyopathy) 8.3-8.3-Pulmonary 8.4-8.4-CNS 8.5-8.5-Renal 8.6-8.6-Other,SpecifyBelow 8.7-8.7-MultipleOrganFailure,SpecifyBelow 8.8-8.8-SecondaryGraftFailure 9.0-9.0-SecondaryMalignancy 9.1-9.1-EBV 9.2-9.2-Other,SpecifyBelow -Hemorhage 10.1-10.1-Pulmonary 10.2-10.2-Intracranial 10.3-10.3-Gastrointestinal 10.4-10.4-HemorhageNotSpecified 10.5-10.5-Other,SpecifyBelow -Vascular 11.1-11.1-Thromboembolic 11.2-11.2-DisseminatedIntravascularCoagulation(DIC) 11.3-11.3-Gastrointestinal 11.4-11.4-ThromboticThrombocytopenicPurpura 11.5-11.5-VascularNotSpecified 11.9-11.9-Other,SpecifyBelow 12.0-12.0-AccidentalDeath 13.0-13.0-Other,SpecifyBelow
BloodandMarrow TransplantClinical TrialsNetwork 0402A(ENR) WebVersion:1.0;6.02;09-22-11 GVHD Prophylaxis-SegmentA 1.Recordthedatepatient'sinformedconsentform was signed:(cn0402dt) (mm/dd/yyyy) 2.Patient'sbirthdate:(PTDBTDT) (mm/dd/yyyy) 3.Recordtheproposedstartdateofconditioning:(CONDDT) (mm/dd/yyyy) 4.Conditioningregimen:(CONDREG) 1-1-CyclophosphamideandTotalBodyIradiation(CY-TBI) 2-2-EtoposideandTotalBodyIradiation(VP16-TBI) InclusionCriteria 5.Recordtheparticipant'sprimarydiagnosis:(PRIMDX) 6.IfAML,recordthediseasestage:(AML402SG) 7.IfALL,recordthediseasestage:(ALL402SG) 8.IfCML,recordthediseasestage:(CML402SG) 9.IfMDS,recordthediseasestage:(MDS402SG) 10.IfAcuteBiphenotypicLeukemia,recordthedisease stage:(abl402sg) 11.IfAcuteBiphenoytpicLeukemia,perwhichhistologywasthe patientbeingtreated?(abl402ht) 1-1-AcuteMyelogenousLeukemia(AML) 2-2-AcuteLymphoblasticLeukemia(ALL) 3-3-ChronicMyelogenousLeukemia(CML) 4-4-MyelodysplasticSyndrome(MDS) 5-5-AcuteBiphenotypicLeukemia 1-1-FirstRemission 2-2-SecondRemission 3-3-SubsequentRemission 1-1-FirstRemission 2-2-SecondRemission 3-3-SubsequentRemission 1-1-ChronicPhase 2-2-AcceleratedPhase 1-1-RefractoryAnemia 2-2-RefractoryAnemiawithRingedSideroblasts 3-3-RefractoryCytopeniawithMultilineageDysplasia 4-4-RefractoryCytopeniawithMultilineageDysplasiaandRingedSideroblasts 5-5-RefractoryAnemiawithExcessBlasts1(5-10% blasts) 1-1-FirstRemission 2-2-SecondRemission 3-3-SubsequentRemission 1-1-AcuteMyelogenousLeukemia(AML) 2-2-AcuteLymphoblasticLeukemia(ALL) 12.Performancestatusscaleusedtoevaluatepatient(Lanskyfor patients<16yearsold;karnofskyforpatients>16years old):(ptkarlan) 13.Recordthepatient'sperformancestatus:(PTKLSCR) 14.Ifthepatientis<18yearsold,indicateifhe/sheiswilingandableto takeoralmedications:(oralmed) 1-Karnofsky 2-Lansky 01-01-100(Normal;NoComplaints/FulyActive) 02-02-90(NormalActivity/MinorRestrictioninStrenuousPlay) 03-03-80(NormalActivitywithEfort/RestrictedinStrenuousPlay) 04-04-70(UnabletoCaryOnNormalActivity/LessTimeSpentinPlay) 05-05-60(RequiresOccasionalAssistance/MinimalActivePlay) 3-NotApplicable MostRecentValue LLNforyourInstitution ULN foryourinstitution DateSampleObtained
15. Serum Creatinine: (SCRESCR) (x.x) mg/dl (SCRELLN) (x.x) mg/dl (SCREULN) mg/dl (x.x) (SCREDT) (mm/dd/yyyy) 16. CalculatedCreatinine Clearance: (CRECLSCR) (xxx) ml/min N/A N/A (CRECLDT) (mm/dd/yyyy) 17. DirectBilirubin: (BILISCR) (x.x) mg/dl 18. ALT: (ALTSCR) (xxx) Units/L N/A (BI402ULN) (x.x) mg/dl N/A (AL402ULN) (xx) Units/L (BILIDT) (mm/dd/yyyy) (ALTDAT) (mm/dd/yyyy) 19. AST: (ASTSCR) (xxx) Units/L N/A (AS402ULN) (xxx) Units/L (ASTDAT) (mm/dd/yyyy) 20. Cholesterol: (CHOLSCR) (xxx) mg/dl 21. Triglycerides: (TRIGSCR) (xxx) mg/dl N/A N/A (CHOLDT) (mm/dd/yyyy) N/A N/A (TRIGDT) (mm/dd/yyyy) 22.Werepulmonaryfunctiontestsperformed?(PULFTST) IfPFT'swerenotperformed,thenanO 2saturationmustbeobtained. MostRecentValueCorectedforHemoglobin DateSampleObtained 23. FVC: (FVCSCR) (xxx) % ofpredictedvalue (FVCDAT) (mm/dd/yyyy) 24. FEV1: (FEV1SCR) (xxx) % ofpredictedvalue (FEV1DAT) (mm/dd/yyyy) 25.O2saturationonroom air:(o2sattst) (xxx) % DateO 2saturationwasobtained:(O2SATDT) (mm/dd/yyyy) 26.Recordthetypeoffractiontestperformed:(FR0402TY) 1-1-LeftVentricularEjectionFraction(LVEF) 2-2-ShorteningFraction 27.Recordtheleftventricularejectionfraction:(EJTFRSCR) (xxx) % Dateejectionfractionperformed:(EJTFRDT) (mm/dd/yyyy) 28.Recordtheshorteningfractionatrest:(SHTFRSCR) (xxx) % Dateshorteningfractionperformed:(SHTFRDT) (mm/dd/yyyy) ExclusionCriteria 29.Hastheparticipanthadaprioralogeneicorautologous transplant?(priortxp) 30.IsthepatientHIVseropositive?(HIVSCR) 31.Isthepatientdiagnosedwithanuncontroledviral,bacterial,orfungal infection?(vibafuif) 32.Isthepatientpregnant(positiveserum orurineβ-hcg)orbreast feeding?(pregscr) 33.Doesthepatienthaveadocumentedalergyto Sirolimus?(SIROALG) 34.IsthepatientcurentlyreceivingVoriconazole?(VORIRX) 35.Isthepatientreceivinganinvestigationaldrug?(INVSDG) 3-NotApplicable 1-2-2-Yes,ApprovedbyStudyChair/MM 3-3-No 36.Dateapprovedbystudychair/medicalmonitor:(DGAPPDT) (mm/dd/yyyy) 37.Doesthepatienthaveahistoryofpriormalignanciesotherthan resectedbasalcelcarcinoma,treatedcarcinomainsituorcancer treatedwithcurativeintent>5yearspreviously?(maligscr) 38.Doesthepatienthaveacancertreatedwithcurativeintent<5years previously?(malig5yr) 1-2-2-Yes,ApprovedbyStudyChair/MM 3-3-No 39.Dateapprovedbystudychair/medicalmonitor:(MAAPPDT) (mm/dd/yyyy) HLATyping TypeofHLAMatchrequiredbythisprotocol:(HLAMATCH) DNA_HIGH-HighLevelDNA DNA_LOW-Low LevelDNA SEROLOGY-Serologic AB_SEROLOGY_DRB1_DNA_LOW-LociA,B:Serologic,LocusDRB1:LowLevelDNA AB_DNA_LOW_DRB1_DNA_HIGH-LociA,B:LowLevelDNA,LocusDRB1:HighLevelDNA
40. RecipientHLATyping HLA-A Typingmethod:(RHLAAMET) Antigens/alelesprovided:(RHLAANUM) 1-1-DNATechnology 2-2-Serology 1-1-One 2-2-Two 1st: (RHLAA11X) (RHLAA12X) / (RHLAA13X) / (RHLAA14X) / (RHLAA15X) (RHLAA16X) / (RHLAA17X) / (RHLAA18X) / 2nd: (RHLAA21X) (RHLAA22X) / (RHLAA23X) / (RHLAA24X) / (RHLAA25X) (RHLAA26X) / (RHLAA27X) / (RHLAA28X) / HLA-B Typingmethod:(RHLABMET) Antigens/alelesprovided:(RHLABNUM) 1-1-DNATechnology 2-2-Serology 1-1-One 2-2-Two 1st: (RHLAB11X) (RHLAB12X) / (RHLAB13X) / (RHLAB14X) / (RHLAB15X) (RHLAB16X) / (RHLAB17X) / (RHLAB18X) / 2nd: (RHLAB21X) (RHLAB22X) / (RHLAB23X) / (RHLAB24X) / (RHLAB25X) (RHLAB26X) / (RHLAB27X) / (RHLAB28X) / HLA-DRB1 Typingmethod:(RHLADMET) Antigens/alelesprovided:(RHLADNUM) 1-1-DNATechnology 2-2-Serology 1-1-One 2-2-Two 1st: (RHLAD11X) (RHLAD12X) / (RHLAD13X) / (RHLAD14X) / (RHLAD15X) (RHLAD16X) / (RHLAD17X) / (RHLAD18X) / 2nd: (RHLAD21X) (RHLAD22X) / (RHLAD23X) / (RHLAD24X) / (RHLAD25X) (RHLAD26X) / (RHLAD27X) / (RHLAD28X) / 41. DonorHLATyping HLA-A Typingmethod:(DHLAAMET) Antigens/alelesprovided:(DHLAANUM) 1-1-DNATechnology 2-2-Serology 1-1-One 2-2-Two 1st: (DHLAA11X) (DHLAA12X) / (DHLAA13X) / (DHLAA14X) / (DHLAA15X) (DHLAA16X) / (DHLAA17X) / (DHLAA18X) / 2nd: (DHLAA21X) (DHLAA22X) / (DHLAA23X) / (DHLAA24X) / (DHLAA25X) (DHLAA26X) / (DHLAA27X) / (DHLAA28X) / HLA-B Typingmethod:(DHLABMET) Antigens/alelesprovided:(DHLABNUM) 1-1-DNATechnology 2-2-Serology 1-1-One 2-2-Two 1st: (DHLAB11X) (DHLAB12X) / (DHLAB13X) / (DHLAB14X) / (DHLAB15X) (DHLAB16X) / (DHLAB17X) / (DHLAB18X) /
2nd: (DHLAB21X) (DHLAB22X) / (DHLAB23X) / (DHLAB24X) / (DHLAB25X) (DHLAB26X) / (DHLAB27X) / (DHLAB28X) / HLA-DRB1 Typingmethod:(DHLADMET) 1-1-DNATechnology 2-2-Serology Antigens/alelesprovided:(DHLADNUM) 1-1-One 2-2-Two 1st: (DHLAD11X) (DHLAD12X) / (DHLAD13X) / (DHLAD14X) / (DHLAD15X) (DHLAD16X) / (DHLAD17X) / (DHLAD18X) / 2nd: (DHLAD21X) (DHLAD22X) / (DHLAD23X) / (DHLAD24X) / (DHLAD25X) (DHLAD26X) / (DHLAD27X) / (DHLAD28X) / Locus-AcalculatedHLAMatchScore(SCORE_A) Locus-BcalculatedHLAMatchScore(SCORE_B) Locus-DRB1calculatedHLAMatchScore(SCORE_D) TotalcalculatedHLAMatchScore(HLASCORE) DoyouagreewiththecalculatedHLAMatchScore?(HLAAGREE) Indicateyourinstitution'sHLAMatchScoreforthis participant:(sitescr) 0/6-0/6 1/6-1/6 2/6-2/6 3/6-3/6 4/6-4/6 Comments(COMMENTS)
AdditionalSelectionOptionsforENR IfMDS,recordthediseasestage: 6-6-RefractoryAnemiawithExcessBlasts-2(10-20% blasts) 7-7-MyelodysplasticSyndrome,Unclassified 8-8-MDSAssociatedwithIsolatedDel(5q) 9-9-ChronicMyelomonocyticLeukemia Recordthepatient'sperformancestatus: 06-06-50(RequiresConsiderableAssistance/NoActivePlay) 07-07-40(Disabled/AbletoInitiateQuietActivities) 08-08-30(SeverelyDisabled/NeedsAssistanceforQuietPlay) 09-09-20(VerySick/LimitedtoVeryPassiveActivity) 10-10-10(Moribund;CompletelyDisabled) TypeofHLAMatchrequiredbythisprotocol: AB_SEROLOGY_DRB1_DNA_HIGH-LociA,B:Serologic,LocusDRB1:HighLevelDNA ABC_DNA_LOW_DRB1_DNA_HIGH-LociA,B,C:LowLevelDNA,LocusDRB1:HighLevelDNA ABCDQ_DNA_LOW_DRB1_DNA_HIGH-LociA,B,C,DQ:Low LevelDNA,LocusDRB1:HighLevelDNA Indicateyourinstitution'sHLA MatchScoreforthisparticipant: 5/6-5/6 6/6-6/6 0/8-0/8 1/8-1/8 2/8-2/8 3/8-3/8 4/8-4/8 5/8-5/8 6/8-6/8 7/8-7/8 8/8-8/8
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): VisitNumber(VISNO): Folow UpStatusForm (FUS) WebVersion:1.0;12.01;06-27-11 1.Dateoflastcontact:(LASTCTDT) (mm/dd/yyyy) Sincethedateofthelastvisitindicateifanyofthefolowinghaveoccurred: 2.Hasthepatientdied?(DIED) IfYes,aDeathForm mustbesubmited. 3.Dateofpatientdeath:(DEATHDT) (mm/dd/yyyy) 4.Hasthepatientrelapsedorexperienceddiseaseprogression?(RELAPSE) IfYes,aRelapseForm mustbesubmited. 5.Dateofrelapseorprogression:(RELAPSDT) (mm/dd/yyyy) 6.Hasthepatientexperiencedsecondarygraftfailure?(SECGRFAL) 7.Hasthepatientexperiencedsecondarygraftfailure?(SECGRFAL) IfYes,aSecondaryGraftFailureForm mustbesubmited. 8.Dateofsecondarygraftfailure:(SCGRFLDT) (mm/dd/yyyy) 9.Dateofsecondarygraftfailure:(SCGRFLDT) (mm/dd/yyyy) 10. 11.Hasthepatientexperiencedanynew clinicalysignificantinfections?(newinfx) IfYes,anInfectionForm mustbesubmited. 12.Dateofinfection:(INFDT) (mm/dd/yyyy) 13.Hasthepatientbeenhospitalized?(HOSPITAL) 14.Dateofhospitalization:(HOSPTLDT) IfYes,aRe-AdmissionForm mustbesubmited. (mm/dd/yyyy) 15.Hasthepatientreceivedanon-protocolspecifiedtransplant?(TRANSTWO) 16.Dateofnon-protocolspecifiedtransplant:(DATRANSP) (mm/dd/yyyy) Comments:(FUS1COMM)
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): VisitNumber(VISNO): AcuteGVHDForm (GVH) WebVersion:1.0;10.04;06-09-11 1.Dateofstaging:(STAGEDT) (mm/dd/yyyy) StartofGVHD AssessmentPeriod:(GVASSTDT) (mm/dd/yyyy) EndofGVHD AssessmentPeriod:(GVASENDT) (mm/dd/yyyy) 2.Recordthestudydrugassignment:(GVHTRAS) 1-Sirolimus/Tacrolimus 2-Tacrolimus/Methotrexate Theassessmentforwhichyouareenteringdatamusthavetakenplacewithintheabovedates.Ifthepatientwasnotseenduringtheassessmentperiodspecifiedabove, pleaseexittheform andrequestanexceptionforthisform. 3.Immunosuppressant(prophylaxis)received:(IMMUNORC) 0-0-Prednisone 1-1-Cyclosporine 2-2-Tacrolimus 3-3-Nottakenduringassessment 4.Recordmostrecentbloodlevelofimmunosuppressant (prophylaxis):(troughlv) (xxxx.x) ng/ml 5.Recorddatebloodsampleobtained:(TROUGHDT) (mm/dd/yyyy)? 6.Recordmostrecentbloodlevelofsirolimus:(GVHSIRLV) (xxxx.x) ng/ml 7.Recorddatebloodsampleobtained:(GVHSIRDT) (mm/dd/yyyy) Recordthehighestleveloforganabnormalities,theetiologiescontributingtotheabnormalitiesandanybiopsyresultsduringtheassessmentperiod. 8.Skinabnormalities:(GVHSKINA) 9.Skinetiologies: 0-0-NoRash 1-1-MaculopapularRash,<25% ofbodysurface 2-2-MaculopapularRash,25-50% ofbodysurface 3-3-GeneralizedErythroderma 4-4-GeneralizedErythrodermawithBulusFormationandDesquamation? GVHD DrugReaction ConditioningRegimenToxicity (SETGVHD)? (SETDRGRX) (SETCRTOX) Infection Other (SETINFCT) (SETOTHER) Specifyotherskinetiologies:(GVHSKNSP) 10.SkinbiopsyforGVHD:(GVHSKINB) 1-1-Positive 2-2-Negative 3-3-Equivocal 4-4-NotDone 11.UpperGIabnormalities:(GVHUPGIA) 0-0-NoProtractedNauseaandVomiting 1-1-PersistentNausea,VomitingorAnorexia 12.Upperintestinaltractetiologies: GVHD DrugReaction ConditioningRegimenToxicity (UGIETGVH) (UGIETDRG) (UGIETCON) TPN Infection Other (UGIETTPN) (UGIETINF) (UGIETOTH)
Specifyotherupperintestinaltractetiologies:(UGIETSPC) 13.UpperintestinaltractbiopsyforGVHD:(UGIBIORS) 1-1-Positive 2-2-Negative 3-3-Equivocal 4-4-NotDone 14.LowerGIabnormalities:(GVHINTA) 0-0-NoDiarhea 1-1-DiarheaLessThanorEqualto500mL/dayor<280mL/m^2 2-2-Diarhea>500butLessThanorEqualto1000mL/dayor280-555mL/m^2 3-3-Diarhea>1000butLessThanorEqualto1500mL/dayor556-833mL/m^2 4-4-Diarhea>1500mL/dayor>833mL/m^2? 15.Lowerintestinaltractetiologies: UsemL/dayforadultpatientsandmL/m 2 forpediatricpatients GVHD DrugReaction ConditioningRegimenToxicity (LGIETGVH) (LGIETDRG) (LGIETCON) TPN Infection Other (LGIETTPN) (LGIETINF) (LGIETOTH) Specifyotherlowerintestinaltractetiologies:(LGIETSPC) 16.LowerintestinaltractbiopsyforGVHD:(LGIBIORS) 1-1-Positive 2-2-Negative 3-3-Equivocal 4-4-NotDone 17.Liverabnormalities:(GVHLIVRA) 0-0-Bilirubin<2.0mg/dL 1-1-Bilirubin2.0-3.0mg/dL 2-2-Bilirubin3.1-6.0mg/dL 3-3-Bilirubin6.1-15.0mg/dL 4-4-Bilirubin>15.0mg/dL 18.Liveretiologies: GVHD DrugReaction ConditioningRegimenToxicity TPN (LIVETGVH) (LIVETDRG) (LIVETCND) (LIVETTPN) Infection VOD Other (LIVETINF) (LIVETVOD) (LIVETOTH) Specifyotherliveretiologies:(GVHLIVRS) 19.LiverbiopsyforGVHD:(GVHLIVRB) 1-1-Positive 2-2-Negative 3-3-Equivocal 4-4-NotDone ')} ThisonlyappliestoTREATMENTforGVHD.IfGVHD prophylaxiswastheonlymodificationduringthisassessmentperiod,thisquestionshouldbeanswered"". 20.Ifyes,specifyagentname:(GVHAGENT) 1-1-CSA 2-2-FK506 3-3-TopicalSteroids 4-4-Prednisone 5-5-ATG Specifyotheragent:(GVHAGNSP)
21.Indicatetreatmentmodification:(GVHTRMOD) 1-1-Started 2-2-Stopped 4-4-Tapered 5-5-Increased Comments:(GVHCOMM)
AdditionalSelectionOptionsforGVH LowerGIabnormalities: 5-5-SevereAbdominalPainwithorwithoutIleus,orStoolwithFrankBloodorMelena Ifyes,specifyagentname: 6-6-MMF 7-7-Daclizumab 8-8-Methylprednisolone 9-9-Other
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): VisitNumber(VISNO): MyeloablativeHematopoiesisForm (HEM) WebVersion:1.0;7.01;03-09-10 1. DidthepatientachieveANC recovery>500/mm 3 onthreeconsecutive days?(engrft1) 3-PreviouslyReported 2.Recordneutrophilcountandspecimencolectiondates: Day1: (ANCDAY1) (xxxxx) /mm 3 (ANC1DT) (mm/dd/yyyy) Day2: (ANCDAY2) (xxxxx) /mm 3 (ANC2DT) (mm/dd/yyyy) Day3: (ANCDAY3) (xxxxx) /mm 3 (ANC3DT) (mm/dd/yyyy) RecordChimerism AssayDataforMarrow and/orblood Marow 3.Wasachimerism performedonamarowsample?(mrwdone) 4.Datespecimencolected:(MRWDT2) (mm/dd/yyyy) 5.Methodofevaluation:(MTHOD1) 1-1-StandardCytogenetics 2-2-FluorescentInSituHybridization(FISH) 3-3-RestrictionFragment-LengthPolymorphisms(RFLP) 4-4-PolymeraseChainReaction(PCR) 5-5-HLASerotyping Specifyother:(MRWSPEC) 6.Celtype:(MRWCLTYP) 7.Marowassayresults:(MRWASSAY) 1-Unmanipulated 1-1-AlHostCels 2-2-AlDonorCels 3-3-HostandDonor 2-Granulocytes 8.% Donor:(PCNTDNR1) (xx) % Blood 9.Wasachimerism performedonabloodsample?(blddone) 10.Datespecimencolected:(BLDCHMDT) 11.Methodofevaluation:(MTHOD2) (mm/dd/yyyy) 1-1-StandardCytogenetics 2-2-FluorescentInSituHybridization(FISH) 3-3-RestrictionFragment-LengthPolymorphisms(RFLP) 4-4-PolymeraseChainReaction(PCR) 5-5-HLASerotyping Specifyother:(BLDSPEC) 12.Celtype:(BLDCLTYP) 13.Bloodassayresults:(BLDASSAY) 1-Unmanipulated 1-1-AlHostCels 2-2-AlDonorCels 3-3-HostandDonor 2-Granulocytes 14.% Donor:(PCNTDNR2) (xx) % TCelChimerism 15.Wasachimerism performedonatcelsample?(tcldone) 16.Typeofsample:(TCLSMPL) 1-Blood 2-Marow 17.Datespecimencolected:(TCLDATE) (mm/dd/yyyy)
18.Methodofevaluation:(MTHOD3) 1-1-StandardCytogenetics 2-2-FluorescentInSituHybridization(FISH) 3-3-RestrictionFragment-LengthPolymorphisms(RFLP) 4-4-PolymeraseChainReaction(PCR) 5-5-HLASerotyping Specifyother:(TCLSPEC) 19.Tcelassayresults:(TCLASSAY) 1-1-AlHostCels 2-2-AlDonorCels 3-3-HostandDonor 20.% Donor:(PCNTDNR3) (xx) % 21.Didthepatientreceiveastem celre-infusionduetoinadequatehematopoietic function?(reinfuse) 22.Recorddateofinfusion:(INFUSEDT) (mm/dd/yyyy) Comments:(HEMCOMM1)
AdditionalSelectionOptionsforHEM Methodofevaluation: 9-9-Other,specify
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): InfectionSite(INFSITE): InfectionStartDate(INFSTDT): InfectionForm (INF) WebVersion:1.0;4.00;12-21-11 INFECTION I 1.Typeofinfection:(INFTYP01) B-B-Bacteria V-V -Viral F-F-Fungal P-P-Protozoal O-O -Other 2.Organism I:(ORGN01) Ifotherspecify:(INFSPEC1) 3.Recordthelevelofcertaintyofthefungalinfectiondiagnosis:(CERTNTY1) 4.Severityofinfection:(SVRTY01) B01-B01-Acinetobacter(baumani,calcoaceticus,lwofi,otherspecies) B02-B02-Agrobacterium radiobacter B03-B03-Alcaligenesxylosoxidans B04-B04-Anaerobicbacteria(NOS,exceptforBacteroides,Clostridium) B05-B05-Bacilus(cereus,otherspecies) 1-1-ProvenFungalInfection 2-2-ProbableFungalInfection 3-3-PossibleFungalInfection 1-1-Moderate 2-2-Severe 3-3-Life-Threatening/Fatal? INFECTION I 5.Typeofinfection:(INFTYP02) B-B-Bacteria V-V -Viral F-F-Fungal P-P-Protozoal O-O -Other 6.Organism I:(ORGN02) Ifotherspecify:(INFSPEC2) 7.Recordthelevelofcertaintyofthefungalinfectiondiagnosis:(CERTNTY2) B01-B01-Acinetobacter(baumani,calcoaceticus,lwofi,otherspecies) B02-B02-Agrobacterium radiobacter B03-B03-Alcaligenesxylosoxidans B04-B04-Anaerobicbacteria(NOS,exceptforBacteroides,Clostridium) B05-B05-Bacilus(cereus,otherspecies) 1-1-ProvenFungalInfection 2-2-ProbableFungalInfection 3-3-PossibleFungalInfection 8.Severityofinfection:(SVRTY02) 1-1-Moderate 2-2-Severe 3-3-Life-Threatening/Fatal INFECTION I 9.Typeofinfection:(INFTYP03) B-B-Bacteria V-V -Viral F-F-Fungal P-P-Protozoal O-O -Other
10.Organism I:(ORGN03) B01-B01-Acinetobacter(baumani,calcoaceticus,lwofi,otherspecies) B02-B02-Agrobacterium radiobacter B03-B03-Alcaligenesxylosoxidans B04-B04-Anaerobicbacteria(NOS,exceptforBacteroides,Clostridium) B05-B05-Bacilus(cereus,otherspecies) Ifotherspecify:(INFSPEC3) 11.Recordthelevelofcertaintyofthefungalinfectiondiagnosis:(CERTNTY3) 1-1-ProvenFungalInfection 2-2-ProbableFungalInfection 3-3-PossibleFungalInfection 12.Severityofinfection:(SVRTY03) 1-1-Moderate 2-2-Severe 3-3-Life-Threatening/Fatal 13.Wasanagent(s)administeredtotreattheinfection(s)?(TRTINF) Provideagent(s)administeredforthisinfectiousperiod: 14. 1 st agent:(agent1) abacavir-abacavir(ziagen) acyclovir-acyclovir(zovirax) albendazole-albendazole(albenza) amantadine-amantadine(symmetrel,symadine) amikacin-amikacin(amikin) Ifotherspecify:(AGTSPEC1) 15. 2 nd agent:(agent2) abacavir-abacavir(ziagen) acyclovir-acyclovir(zovirax) albendazole-albendazole(albenza) amantadine-amantadine(symmetrel,symadine) amikacin-amikacin(amikin) Ifotherspecify:(AGTSPEC2) 16. 3 rd agent:(agent3) abacavir-abacavir(ziagen) acyclovir-acyclovir(zovirax) albendazole-albendazole(albenza) amantadine-amantadine(symmetrel,symadine) amikacin-amikacin(amikin) Ifotherspecify:(AGTSPEC3) 17.Wereadditionalagentsadministeredforthisinfectiousperiod?(ADDAGENT) Ifyes,specifyadditionalagentsadministered:(INFSPEC4) Comments:(INFCOM)
AdditionalSelectionOptionsforINF InfectionSite(INFSITE)(keyfield): 01-01-Blood/BufyCoat 02-02-Disseminated-Generalized,Isolatedat2orMoreDistinctSites 03-03-Brain 04-04-SpinalCord 05-05-MeningesandCSF 06-06-CentralNervousSystem Unspecified 07-07-Lips 08-08-Tongue,OralCavity,andOro-Pharynx 09-09-Esophagus 10-10-Stomach 11-11-GalbladderandBiliaryTree(NotHepatitis),Pancreas 12-12-SmalIntestine 13-13-LargeIntestine 14-14-Feces/Stool 15-15-Peritoneum 16-16-Liver 17-17-GastrointestinalTractUnspecified 18-18-UpperAirwayandNasopharynx 19-19-Larynx 20-20-LowerRespiratoryTract(Lung) 21-21-PleuralCavity,PleuralFluid 22-22-Sinuses 23-23-RespiratoryTractUnspecified 24-24-Kidneys,RenalPelvis,UretersandBladder 25-25-Prostate 26-26-Testes 27-27-FalopianTubes,Uterus,Cervix 28-28-Vagina 29-29-Genito-UrinaryTractUnspecified 30-30-GenitalArea 31-31-Rash,Pustules,orAbscessesNotTypicalofAnyoftheAbove 32-32-SkinUnspecified 33-33-Woundsite 34-34-CatheterTip 35-35-Eyes 36-36-Ears 37-37-Joints 38-38-BoneMarow 39-39-BoneCortex(Osteomyelitis) 40-40-Muscle(ExcludingCardiac) 41-41-Cardiac(Endocardium,Myocardium,Pericardium) 42-42-LymphNodes 43-43-Spleen 99-99-OtherUnspecified Organism I: B06-B06-Bacteroides(gracilis,uniformis,vulgaris,otherspecies) B07-B07-Borrelia(Lymedisease) B08-B08-BranhameliaorMoraxelacatarhalis(otherspecies) B09-B09-Campylobacter(alspecies) B11-B11-Chlamydia B12-B12-Citrobacter(freundi,otherspecies) B13-B13-Clostridium (alspeciesexceptdificile) B14-B14-Clostridium dificile B15-B15-Corynebacterium (alnon-diptheriaspecies) B16-B16-Coxiela B17-B17-Enterobacter B18-B18-Enterococcus(alspecies) B19-B19-Escherichia(alsoE.coli) B20-B20-Flavimonasoryzihabitans B21-B21-Flavobacterium B22-B22-Fusobacterium nucleatum B23-B23-Gram NegativeDiplococci(NOS) B24-B24-Gram NegativeRod(NOS) B25-B25-Gram PositiveCocci(NOS) B26-B26-Gram PositiveRod(NOS) B27-B27-Haemophilus(alspeciesincludinginfluenzae) B28-B28-Helicobacterpylori B29-B29-Klebsiela B30-B30-Lactobacilus(bulgaricus,acidophilus,otherspecies) B31-B31-Legionela B32-B32-Leptospira B33-B33-Leptotrichiabuccalis B34-B34-Leuconostoc(alspecies) B35-B35-Listeria B36-B36-Methylobacterium B37-B37-Micrococcus(NOS) B38-B38-Mycobacteria(avium,bovium,haemophilum,intercelulare) B39-B39-Mycoplasma B40-B40-Neisseria(gonorhoea,meningitidis,otherspecies) B41-B41-Nocardia B42-B42-Pharyngeal/RespiratoryFlora B43-B43-Propionibacterium (acnes,avidum,
granulosum,otherspecies) B44-B44-Pseudomonas(alspeciesexcept cepaciaandmaltophilia) B45-B45-PseudomonasorBurkholderiacepacia B46-B46-PseudomonasorStenotrophomonasorXanthomonasmaltophilia B47-B47-Rhodococcus B48-B48-Ricketsia B49-B49-Salmonela(alspecies) B50-B50-Serratiamarcescens B51-B51-Shigela B52-B52-Staphylococcus(coag-) B53-B53-Staphylococcus(coag+) B54-B54-Staphylococcus(NOS) B55-B55-Stomatococcusmucilaginosis B56-B56-Streptococcus(alspeciesexceptEnterococcus) B57-B57-Treponema(syphilis) B58-B58-Tuberculosis(NOS,AFB,acidfastbacilus,Kochbacilus) B59-B59-TypicalTuberculosis(TB,Tuberculosis) B60-B60-Vibrio(alspecies) B99-B99-OtherBacteria V01-V01-HerpesSimplex(HSV1,HSV2) V02-V02-HerpesZoster(Chickenpox,Varicela) V03-V03-Cytomegalovirus(CMV) V04-V04-Adenovirus V05-V05-Enterovirus(Coxsackie,Echo,Polio) V06-V06-HepatitisA(HAV) V07-V07-HepatitisB(HBV,Australianantigen) V08-V08-HepatitisC (includesnon-aandnon-b,hcv) V09-V09-HIV-1,HITLV-I V10-V10-Influenza(Flu) V11-V11-Measles(Rubeola) V12-V12-Mumps V13-V13-Papovavirus V14-V14-RespiratorySyncytialvirus(RSV) V15-V15-Rubela(GermanMeasles) V16-V16-Parainfluenza V17-V17-HHV-6(HumanHerpesVirus) V18-V18-Epstein-BarVirus(EBV) V19-V19-Polyomavirus V20-V20-Rotavirus V21-V21-Rhinovirus(CommonCold) V22-V22-OtherViral P01-P1-Pneumoncystis(PCP) P02-P2-Toxoplasma P03-P3-Giardia P04-P4-Cryptosporidium P05-P5-Amebiasis P06-P6-Echinocoocalcyst P07-P7-Trichomonas(eithervaginalorgingivitis) P08-P8-OtherProtozoal(Parasite) O01-O1-Mycobacterium Tuberculosis O02-O2-OtherMycobacterium O03-O3-Mycoplasma O04-O4-OtherOrganism F01-F01-CandidaAlbicans F02-F02-CandidaKrusei F03-F03-CandidaParasilosis F04-F04-CandidaTropicalis F05-F05-TorulopsisGalbrata(asubspeciesofCandida) F06-F06-Candida(NOS) F07-F07-AsperguilusFlavus F08-F08-AsperguilusFumigatus F09-F09-AsperguilusNiger F10-F10-Asperguilus(NOS) F11-F11-CryptococcusSpecies F12-F12-Fusarium Species F13-F13-Mucormycosis(Zygomycetes,Rhizopus) F14-F14-Yeast(NOS) F15-F15-OtherFungus 1 st agent: amoxicilin/clavulanate-amoxicilin/clavulanate(augmentin) amphotericinb-amphotericinb(abelcet,amphotec,fungizone) ampicilin-ampicilin(omnipen,polycilin) ampicilin/sulbactam-ampicilin/sulbactam (Unasyn) amprenavir-amprenavir(agenerase) atovaquone-atovaquone(meprone) azithromycin-azithromycin(zithromax,z-pack) cefaclor-cefaclor(ceclor) cefadroxil-cefadroxil(duricef,ultracef) cefazolin-cefazolin(ancef,kefzol) cefdinir-cefdinir(omnicef) cefepime-cefepime(maxipime) cefixime-cefixime(suprax) cefoperazone-cefoperazone(cefobid) cefotaxime-cefotaxime(claforan) cefotetan-cefotetan(cefotan)
cefoxitin-cefoxitin(mefoxin) cefpodoxime-cefpodoxime(vantin) cefprozil-cefprozil(cefzil) ceftazidime-ceftazidime(fortaz,tazicef) ceftriaxone-ceftriaxone(rocephin) cefuroxime-cefuroxime(ceftin,kefurox,zinacef) cephalexin-cephalexin(keflet,keflex,keftab) chloramphenicol-chloramphenicol(chloromycetin) cidofovir-cidofovir(vistide) ciprofloxacin-ciprofloxacin(cipro) clarithromycin-clarithromycin(biaxin) clindamycin-clindamycin(cleocin) clotrimazole-clotrimazole(mycelex,lotrimin) clotrimoxazole/betamethasone-clotrimoxazole/betamethasone(lotrisone) co-trimoxazole-co-trimoxazole(bactrim,septra,sulfamethoprim) dapsone-dapsone(dds) dicloxacilin-dicloxacilin(dycil,dynapen,pathocil) didanosine-didanosine(videx,ddi) doxycycline-doxycycline(vibramycin) efavirenz-efavirenz(sustiva) erythromycin-erythromycin(ery-tab,ilosone,pediamycin) erythromycin/sulfisoxazole-erythromycinethyl/sulfisoxazole(pediazole) erythromycintopical-erythromycintopical(akne-mycin,eryderm) ethambutol-ethambutol(myambutol) famciclovir-famciclovir(famvir) fluconazole-fluconazole(diflucan) flucytosine-flucytosine(ancobon) foscarnet-foscarnet(foscavir) ganciclovir-ganciclovir(cytovene) gatifloxacin-gatifloxacin(tequin) gentamicin-gentamicin(garamycin,gentacidin) grepafloxacin-grepafloxacin(raxar) hepatitisavaccine-hepatitisavaccine(havrix,vaqta) hepatitisbvaccine-hepatitisbvaccine(recombivaxhb,engerix-b) hepatitiscvaccine-hepatitiscvaccine imipenem /cilastatin-imipenem /cilastatin(primaxin) imiquimod-imiquimod(aldara) indinavir-indinavir(crixivan) interferonalfacon-1-interferonalfacon-1(infergen) interferonbeta-1a-interferonbeta-1a(avonex) interferonbeta-1b-interferonbeta-1b(betaseron) isoniazid-isoniazid(inh,lanizid,nydrazid) itraconazole-itraconazole(sporonox) ivermectin-ivermectin(stromectol) kanamycin-kanamycin(kantrex) ketoconazole-ketoconazole(nizoral) lamivudine-lamivudine(epivir,3tc) levofloxacin-levofloxacin(levaquin) linezolid-linezolid(zyvox) lopinavir/ritonavir-lopinavir/ritonavir(kaletra) mefloquine-mefloquine(larium) meropenem-meropenem (Merem I.V.) metronidazole-metronidazole(flagyl,protostat) minocycline-minocycline(arestin) moxifloxacinhydrochloride-moxifloxacinhydrochloride(avelox) mupirocin-mupirocin(bactroban) nafcilin-nafcilin(nalpen,unipen) nelfinavir-nelfinavir(viracept) neomycin-neomycin(mycifradin,myciguent) neomycin/polymxin/hydrocortisone-neomycin/polymxin/hydrocortisone(cortisporin) nevirapine-nevirapine(viramune) nitrofurantoin-nitrofurantoin(macrobid) nystatin-nystatin(mycostatin) oseltamivir-oseltamivir(tamiflu) oxacilin-oxacilin(bactocil) palivizumab-palivizumab(synagis) peniciling-peniciling(bicilin) penicilinvk-penicilinvk(v-cilink,veetids) pentamidine-pentamidine(pentam 300) piperacilin-piperacilin(pipracil) piperacilin/tazobactam-piperacilin/tazobactam (Zosyn) podofilox-podofilox(condylox) polymyxin-polymyxin(ak-sporeh.c.,cortisporinophthalmicsuspension) ppd-ppd skintest(mantouxtest,tinetest) pyrazinamide-pyrazinamide(rifater) pyrimethamine-pyrimethamine(daraprim) quinidinegluconate-quinidinegluconate(duraquin,cardioqiuin) quinupristin/dalfopristin-quinupristin/dalfopristin(synercid) respiratorysyncytialimmuneglobulin-respiratorysyncytialimmuneglobulin(respigam) ribavirin-ribavirin(virazole) rifampin-rifampin(rifadin,rimactane) rifampin/isoniazid-rifampin/isoniazid(rifamate,rimactane/inh) rifampin/isoniazid/pyrazinamide-rifampin/isoniazid/pyrazinamide(rifater) rimantadine-rimantadine(flumadine) ritonavir-ritonavir(norvir) saquinavirmesylate-saquinavirmesylate(fortovase,invirase) stavudine-stavudine(d4t,zerit)