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.fungalinfection:(reasfinf) 1-Contributory ncontributory e.non-fungalinfection:(reasnfin) 1-Contributory ncontributory f.fever:(reasfvr) 1-Contributory ncontributory g.seizure:(reasszr) 1-Contributory ncontributory h.bleeding/hemorhage:(reasgibl) 1-Contributory ncontributory i.diarhea:(reasdrh) 1-Contributory ncontributory j.nausea/vomiting:(reasnv) 1-Contributory ncontributory k.organfailure:(reasorgf) 1-Contributory ncontributory Specifyorgan:(ADM3SPEC) l.trauma:(reastram) 1-Contributory ncontributory m.psychiatric:(reaspsyc) 1-Contributory ncontributory n.secondarymalignancy:(reasmalg) 1-Contributory ncontributory o.scheduledprocedure/treatment:(reasproc) 1-Contributory ncontributory p.thrombosis/thrombus/embolism:(reastrmb) 1-Contributory ncontributory q.other:(reasothr) 1-Contributory ncontributory Specifyother:(ADM2SPEC) 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) 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) 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) 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) 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) 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) 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 Segment(PROTSEG): SampleEvents(SAMPEVEN): DateEventOccurred(DATOCCRD): SpecimenAcquisitionsForm -Event-DrivenSamples(EDS) WebVersion:1.0;4.01;03-09-10 Pharmacokinetics 1.Recorddatestudydruginfusedororalyadministered:(DATEINFA) (mm/dd/yyyy) 2.Recordtimestudydruginfusedororalyadministered:(TIMEINFA) (hh:mm) 3.Recorddatesamplecolected:(PHARDATE) (mm/dd/yyyy) 4.Recordtimesamplecolected:(PHARTIME) (hh:mm) 5.Window oftimeafterstartofinfusionoradministrationoforaldosesamplewas drawn:(winsacol) 1-1-Window 1(1-5HoursafterInfusion/Administration) 2-2-Window 2(5-8HoursafterInfusion/Administration) 3-3-Window 3(8-12HoursafterInfusion/Administration) 4-4-Other Note:SamplesmustbecolectedtwiceweeklyduringempiricaltherapywithAmphoB orcaspofunginforupto14days. Note:Samplesmustbecolectedtwiceweeklyfor4weeksandthenonceevery2weeksfor8weeks(foratotalof12samples)duringantifungaltherapy. InvestigationalFungalDiagnosticAssays Note:2samplesmustbecolected;1forbloodand1forserum. 6.Recorddatesamplescolected:(FDDATE) 7. (mm/dd/yyyy) Sample(1bloodand1serum) Wasasamplecolected? DateColected Week1,1stColection (E4F1W1CL) (FDDAT411) (mm/dd/yyyy) Week1,2ndColection (E4F1W2CL) (FDDAT412) (mm/dd/yyyy) Week2,1stColection (E4F2W1CL) (FDDAT421) (mm/dd/yyyy) Week2,2ndColection (E4F2W2CL) (FDDAT422) (mm/dd/yyyy) 8. Sample(1Bloodand1Serum) Wasasamplecolected? DateColected Week1,1stColection (E5F1W1CL) (FDDAT511) (mm/dd/yyyy) Week1,2ndColection Week2,1stColection (E5F1W2CL) (FDDAT512) (mm/dd/yyyy) (E5F2W1CL) (FDDAT521) (mm/dd/yyyy) Week2,2ndColection (E5F2W2CL) (FDDAT522) (mm/dd/yyyy) Week3,1stColection (E5F3W1CL) (FDDAT531) (mm/dd/yyyy) Week3,2ndColection Week4,1stColection (E5F3W2CL) (FDDAT532) (mm/dd/yyyy) (E5F4W1CL) (FDDAT541) (mm/dd/yyyy) Week4,2ndColection (E5F4W2CL) (FDDAT542) (mm/dd/yyyy) Week6Colection (E5F6WCL) (FDDATE56) (mm/dd/yyyy) Week8Colection (E5F8WCL) (FDDATE58) (mm/dd/yyyy) Week10Colection (E5F10WCL) (FDDAT510) (mm/dd/yyyy) Week12Colection (E5F12WCL) (FDDAT125) (mm/dd/yyyy) AntifungalSusceptibilityTesting 9.WasasampleforAntifungalSusceptibilityTestingcolected?(AFUNOBT) 10.Recorddatesamplecolected:(AFUNDAT) (mm/dd/yyyy)
InfectedTissue 11.Wasaparafinblockofinfectedtissueobtained?(INFTOBT) 12.Recorddatesamplecolected:(INFTDAT) (mm/dd/yyyy) InvestigationalGalactomannanAssay 13.WasaBALsampleobtained?(BALOBT) 14.Recorddatesamplecolected:(BALDAT) (mm/dd/yyyy) DiagnosticGalactomannanAssay 15.Recorddatethesamplewascolected:(DGADAT2) (mm/dd/yyyy) 16. BloodSample Wasasamplecolected? DateColected Week1,1stColection (E4G1W1CL) (DGDAT411) (mm/dd/yyyy) Week1,2ndColection (E4G1W2CL) (DGDAT412) (mm/dd/yyyy) Week2,1stColection (E4G2W1CL) (DGDAT421) (mm/dd/yyyy) Week2,2ndColection (E4G2W2CL) (DGDAT422) (mm/dd/yyyy) InvestigationalMonitoringofTreatmentGalactomannanAssays 17.Recorddatesamplecolected:(MGADATE) (mm/dd/yyyy) 18. BloodSample Wasasamplecolected? DateColected Week1,1stColection (E5G1W1CL) (DGDAT511) (mm/dd/yyyy) Week1,2ndColection (E5G1W2CL) (DGDAT512) (mm/dd/yyyy) Week2,1stColection (E5G2W1CL) (DGDAT521) (mm/dd/yyyy) Week2,2ndColection (E5G2W2CL) (DGDAT522) (mm/dd/yyyy) Week3,1stColection (E5G3W1CL) (DGDAT531) (mm/dd/yyyy) Week3,2ndColection (E5G3W2CL) (DGDAT532) (mm/dd/yyyy) Week4,1stColection (E5G4W1CL) (DGDAT541) (mm/dd/yyyy) Week4,2ndColection (E5G4W2CL) (DGDAT542) (mm/dd/yyyy) Week6Colection (E5G6WCL) (DGDATE56) (mm/dd/yyyy) Week8Colection (E5G8WCL) (DGDATE58) (mm/dd/yyyy) Week10Colection (E5G10WCL) (DGDAT510) (mm/dd/yyyy) Week12Colection (E5G12WCL) (DGDAT125) (mm/dd/yyyy) Comments:(EDSCOMM)
AdditionalSelectionOptionsforEDS SampleEvents(SAMPEVEN)(keyfield): 1-1-OnsetofSerious,SuspectedDrugToxicity 2-2-OnsetofPossibleFungalInfection 3-3-OnsetofPresumptive,ProbableorProvenFungalInfection 4-4-TreatmentofPossibleFungalInfectionwithEmpiricalAmphotericinBorCaspofungin 5-5-TreatmentofPresumptive,ProbableorProvenFungalInfectionwithAntifungalTherapy 6-6-InfectionRelapseAfterDiscontinuationofAntifungalTherapy 7-7-BronchoscopyPerformed
BloodandMarrow TransplantClinical TrialsNetwork 0101B(ENR) WebVersion:1.0;3.00;08-10-09 1.Recorddateofinitiationofconditioning:(CONDINDT) (mm/dd/yyyy) 2.Recordproposeddateoftransplant:(PROPTXDT) (mm/dd/yyyy) 3.Recordthefolowinginformationwithin72hoursofDay0(dateoftransplant): MostRecentValue ULN foryourinstitution DateSampleObtained ALT: (ALT72HRS) (xxx) Units/L (ALTULN72) (xx) Units/L (ALTDTOBT) (mm/dd/yyyy) 4.WasabaselineGM bloodsampledrawn?(gmadraw) 5.RecorddatebaselineGM samplewasdrawn:(gmadrwdt) (mm/dd/yyyy) 6.HaveresultsofthebaselineGM samplebeenobtained?(gmreslts) 7.WasaCT scanofthechestobtainedwithinthelast6weeks?(ctscan) 8.RecorddateCT scanwasobtained:(ctscandt) (mm/dd/yyyy) Comments:(COMM1ENR)
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): InfectionStartDate(INFSTDT): FungalInfectionForm (FIN) WebVersion:1.0;5.00;04-20-09 1.Whatisthepatient'sfungalinfectiongrade?(FINGRADE) 1-1-ProvenFungalInfection 2-2-ProbableFungalInfection 3-3-PossibleFungalInfection 4-4-PresumptiveFungalInfection 5-5-PossibleDuetoGM Only CompleteSpecimenAcquisitionsForm -EventDrivenSamplestorecordsample(s)obtainedfordiagnosisofproven,probable,presumptiveorpossiblefungalinfection. 2.Doesthepatienthaveadeeptissueinfection?(DPTISINF) 3.Recordthetypeofdeeptissueinfection:(TYPDPTIS) 1-1-Mold 2-2-Yeast 3-3-Other 4.Recordorganism:(DTIORG) 01-01-AspergilusFlavus 02-02-AspergilusFumigatus 03-03-AspergilusNiger 04-04-AspergilusTereus 05-05-Aspergilus(NOS) Specifyother:(DTORGSPC) 5.Recordbiopsy/needleaspirateresults:(DTBIOPSY) 3-3-NotDone 6.Recordbiopsy/needleaspiratesite:(DTBIOPST) 02-02-Disseminated-Generalized,Isolatedat2orMoreDistinctSites 00 -CentralNervousSystem - 03-03-Brain 04-04-SpinalCord 05-05-MeningesandCSF Ifdisseminated,recordthe2ormorepositivesites:(DTDISEMB) 7.Recordspecimentype:(DTBIOPSP) 1-1-Tissue 2-2-Fluid 3-3-MucousMembranes 4-4-CSF 5-5-Urine 8.Wereotherbiopsy/needleaspirateresultsobtained?(DTOTHRBP) Specifyotherbiopsy/needleaspiratesitesandtheirresults(positiveor negative):(dtothbsp) 9.Recordcultureresults:(DTCULTRS) 3-3-NotDone 10.Recordculturesite:(DTCULTST) 01-01-Blood/BufyCoat 02-02-Disseminated-Generalized,Isolatedat2orMoreDistinctSites 03-03-Brain 04-04-SpinalCord 05-05-MeningesandCSF Ifdisseminated,recordthe2ormorepositivesites:(DTDISCLT)
11.Recordspecimentype:(DTSPECTY) 1-1-Urine 2-2-MucousMembranes 3-3-CSF 4-4-Blood(Whole,Plasma,orSerum) 5-5-Sputum 12.Wereothercultureresultsobtained?(DTOTHCLT) Specifyotherculturesitesandtheirresults(positiveor negative):(dtothcst) 13.Recordmicroscopicexaminationresults:(DTMICRO) 3-3-NotDone 14.Recordspecimentype:(DTMCROST) 1-1-Urine 2-2-MucousMembranes 3-3-CSF 4-4-Blood(Whole,Plasma,orSerum) 5-5-Sputum 15.RecordCSFantigentestingresults:(DTANTIGN) 3-3-NotDone 16.Recordhistopathologicexaminationresults:(DTHISTO) 3-3-NotDone 17.Recordcytopathologicexaminationresults:(DTCYTOEX) 3-3-NotDone 18.Werehyphaepresent?(DTHYPHAE) 19.Wasthereevidenceofassociatedtissuedamage(eithermicroscopicalyor unequivocalybyimaging)?(dttisdmg) 20.Wereyeastcelspresent?(DTYEASTC) 21.Doesthepatienthavefungemia?(FUNGEMIA) 22.Recordtypeoffungemia:(FUNGTYPE) 1-1-Mold 2-2-Yeast 3-3-Other 23.Recordorganism:(FUNGORG) 01-01-AspergilusFlavus 02-02-AspergilusFumigatus 03-03-AspergilusNiger 04-04-AspergilusTereus 05-05-Aspergilus(NOS) Specifyother:(FNGORGSP) 24.Recordcultureresults:(FUNGCULT) 3-3-NotDone 25.Didthecultureyieldaspergilusspecies?(FGCAPERG) 26.Didthecultureyieldpenicilium species?(fgcpenic) 27.Wasthespeciespenicilium marnefei?(fgcpmarn) 28.Doesthepatienthaveanendemicfungalinfection?(ENDEMIC) 29.Recordcultureresults:(ENDCULT) 3-3-NotDone
30.Recordculturesite:(ENDCLTRS) 1-1-Blood/BufyCoat 2-2-Disseminated-Generalized,Isolatedat2orMoreDistinctSites 3-3-MeningesandCSF 4-4-LowerRespiratoryTract(Lung) 5-5-Kidneys,RenalPelvis,UretersandBladder Ifdisseminated,recordthe2ormorepositivesites:(ENDDISCL) 31.Recordspecimentype:(ENDCLTSP) 1-1-Blood(Whole,PlasmaorSerum) 2-2-Urine 3-3-BronchoalveolarLavageFluid 4-4-Tissue 32.Recordorganism(s)present:(ENDORGAN) 1-1-Histoplasmosis 2-2-Blastomycosis 3-3-Coccidioidomycosis 4-4-Paracoccidioidomycosis 5-5-MultipleOrganisms Specifymultipleendemicorganisms:(ENDORGSP) 33.RecordRIAresults:(ENDRIA) 3-3-NotDone 34.RecordRIAspecimentype:(ENDRIAST) 35.Recordhistopathologicexaminationresults:(ENDHISTO) 1-Urine 3-3-NotDone 2-Blood(Whole,PlasmaorSerum) 36.Weretheappropriatemorphologicalformspresent?(ENDMRPH1) 37.Recordmicroscopicexaminationresults:(ENDMICRO) 3-3-NotDone 38.Weretheappropriatemorphologicalformspresent?(ENDMRPH2) 39.Istheinfectionsystemic?(ENDSYSTE) 40.Istheinfectionconfinedtothelungs?(ENDLUNGS) HostFactors Indicateifthepatientmeetsanyofthehostfactorsbelow relativetotheinfectionstartdate: 41 Ṅeutropenia(<500neutrophils/mm 3 for>10days)?(neutrop) Tendayspriortoinfectionstartdate:(NEUTRDT) (mm/dd/yyyy) 42.Persistentfeverfor>96hours?(PERSFEVR) 96hourspriortoinfectionstartdate:(PERFEVDT) (mm/dd/yyyy) 43.Wasthefeverrefractorytobroad-spectrum antibacterialtreatment?(rfrcrx) 44 Ẇasthebodytemperatureeither>38 o or<36 o C?(BODYTEMP) 45.Prolongedneutropenia(>10days)inprevious60days?(PRONEUT) 60dayspriortoinfectionstartdate:(PRNEUTDT) (mm/dd/yyyy) 46.Useofsignificantimmunosuppressiveagentsinprevious30days(IMUNAGNT) 30dayspriortoinfectionstartdate:(IMUNAGDT) 47.Priorproven,probableorpresumptivefungalinfectionduringapreviousepisode ofneutropenia?(prevneut) 48.Acutegraft-versus-hostdisease(Grade>2orextensivechronic disease)?(gvhdsgns) 49.Useofsystemiccorticosteroidsfor3weeksormoreintheprevious60 days?(crtstrds) 50.Recordaveragedailydoseofsystemiccorticosteroids3weeksbeforethe infectionstartdate:(avgdose) (mm/dd/yyyy) 60dayspriortoinfectionstartdate:(CORTICDT) 1-1-0mg/kd/day 2-2-<1mg/kg/day 3-3-1-2mg/kg/day 4-4->2mg/kg/day (mm/dd/yyyy) (mm/dd/yyyy) 3weekspriortoinfectionstartdate:(AVGDSDT) MicrobiologicalFactors
Indicateifthepatientmeetsanyofthemicrobiologicalfactorsbelow: 51.Cultureformold(includingAspergilus,Fusaruim,Scedosporium speciesor Zygomycetes):(CULTMOLD) 3-3-NotDone 52.Recordculturemethod:(CLTMTHD1) 53.CultureforCryptococcusneoformans:(CNEOFORM) 1-Sputum Sample 3-3-NotDone 2-BronchoalveolarLavageFluidSample 54.Recordculturemethod:(CLTMTHD2) 1-Sputum Sample 2-BronchoalveolarLavageFluidSample 55.Cultureforanendemicfungalpathogen(i.e.histoplasmosis,blastomycosis, coccidioidomycosisandparacoccidioidomycosis):(cendpath) 3-3-NotDone 56.Recordculturemethod:(CLTMTHD3) 1-Sputum Sample 2-BronchoalveolarLavageFluidSample 57.Cultureorfindingsofcytologic/directmicroscopicevaluationformoldfrom sinus aspiratespecimen?(csinus) 3-3-NotDone 58.Cytologic/directmicroscopicevaluationformold?(CYTMOLD) 3-3-NotDone 59.Recordevaluationmethod:(CLTMTHD4) 60.Cytologic/directmicroscopicevaluationforCryptococcusspecies?(CYTCRYPT) 1-Sputum Sample 3-3-NotDone 2-BronchoalveolarLavageFluidSample 61.Recordevaluationmethod:(CLTMTHD5) 1-Sputum Sample 2-BronchoalveolarLavageFluidSample 62.ResultforGalactomannanAssayinabloodsample?(GMBLOOD) 3-3-NotDone 63.WasthepatientonZosynattimeofblooddraw?(ZOSYN1) PatientmustbeofZosynfor5dayspriortoalowanceofapositiveGM resultasamicrobiologicalcriteriontosupportdocumentationofaninvasive(proven, probable,presumptiveorpossible)fungalinfection. 64.ResultforGalactomannanAssayinsampleotherthanblood?(GMOTHER) 3-3-NotDone 65.Recordspecimentype:(GMOTHSPC) 1-BronchoalveolarLavageFluid 2-CSF 66.WasthepatientonZosynattimeofsampledraw?(ZOSYN2) PatientmustbeofZosynfor5dayspriortoalowanceofapositiveGM resultasamicrobiologicalcriteriontosupportdocumentationofaninvasive(proven, probable,presumptiveorpossible)fungalinfection. 67.Resultforcryptococcalantigeninbloodsample?(CRYPTBLD) 3-3-NotDone 68.Cytologicordirectmicroscopicexaminationforfungalelementsinsterilebodyfluid sample?(fngelemn) 3-3-NotDone 69.ResultforHistoplasmacapsulatum antigen?(histocap) 3-3-NotDone 70.Recordspecimentype:(HISTOSPM) 1-1-Blood 2-2-Urine 3-3-CSF 71.Cultureorurinesamplesforyeastinabsenceofurinarycatheter?(CULTYEAS) 3-3-NotDone 72.Weretwopositivesamplesobtained?(TWOPOSY)
73.Candidacastsinurineinabsenceofurinarycatheter?(CANDIDAU) 3-3-NotDone ClinicalFactors Indicateifthepatientmeetsanyoftheclinicalfactorsbelow: LowerRespiratoryTractInfection: 74.New infiltratesdetectedbyctimaging?(newinflt) 1-2- 3-3-NotApplicable 75.Recordthenewinfiltrate:(INFLTRTS) 1-1-Halo-Sign 2-2-Air-CrescentSign 3-3-CavitywithinAreaofConsolidation 4-4-WedgeShapedInfiltrate 5-5-NewNonspecificFocalInfiltrate Specifyotherinfiltrate:(FIN1SPEC) Ifthenew infiltrateishalo-sign,wasthereaweldefinednoduleofatleast1 cm indiameter?(inflhalo) 76.Lowerrespiratorysymptoms?(LOWRRESP) Recordsymptomsoflowerrespiratorytractinfection. 77.Cough:(RSPCOUGH) 78.Chestpain:(RSPCHSTP) 79.Hemoptysis:(RSPHEMOP) 80.Dyspnea:(RSPDYSPN) 81.Other:(RSPOTHER) Specifyotherlowerrespiratorytractsymptoms:(FIN2SPEC) 82.Physicalfindingsofpleuralrub?(PLEURRUB) 83.Pleuralefusion?(PLEUREFF) 84.Pleuralpain?(PLEUPAIN) 85.Broncoscopicevidencesuggestingotheretiology?(BRONCEDI) Ifyes,specifyotheretiology:(OTHRETIO) SinonasalInfection: 86.Radiologicalevidenceofinvasiveinfectioninsinuses?(INVSINUS) 1-2- 3-3-NotApplicable 87.Recordradiologicalevidence:(INFEVID) 1-1-ErosionofSinusWalsorExtensionofInfectiontoNeighboringStructures 2-2-ExtensiveSkulBaseDestruction 3-3-Other Specifyotherradiologicevidence:(FIN3SPEC) 88.Upperrespiratorysymptoms?(UPPRRESP) Recordsymptomsofupperrespiratoryinfection. 89.Nasaldischarge:(UPPRNSLD) 90.Stufiness:(UPPRSTUF) 91.Other:(UPPROTHR) Specifyothersymptoms:(FIN4SPEC) 92.Noseulceration?(ULCRATN) 93.Escharofnasalmucosa?(NSLMUCSA) 94.Epistaxis?(EPISTAXS) 95.Periorbitalsweling?(ORBTLSWL) 96.Maxilarytenderness?(MAXTNDRN) 97.Blacknecroticlesions?(NCRTCLSN) 98.Perforationofhardpalate?(PERFPLT) CNS Infection:
99.RadiologicalevidencesuggestingCNSinfection?(CNSRAD) 1-2- 3-3-NotApplicable 100.Recordradiologicevidence:(RADEVIDN) 1-1-Mastoiditis 2-2-OtherParameningealFoci 3-3-ExtraduralEmpyema 4-4-IntraparenchymalBrainLesion 5-5-SpinalCordMassLesion Specifyotherradiologicalevidence:(FIN5SPEC) 101.Focalneurologicalsymptomsandsigns?(NEUROINF) Recordfocalneurologicalsymptomsandsigns. 102.Focalseizures:(NEURFOCL) 103.Hemiparesis:(NEURHEMI) 104.Cranialnervepalsies:(NEURCRNI) 105.Other:(NEUROTHR) Specifyotherfocalneurologicalsymptomsandsigns:(FIN6SPEC) 106.Mentalchanges(e.g.lethargy,delerium,stupor)?(MNTLCHNG) 107.Meningealiritationfindings(e.g.photophobia,stifneck)?(MENINGEL) 108.AbnormalitiesinCSFbiochemistryandcelcount?(CSFABNRM) 1-2- 3-3-NotApplicable 109.IsCSFnegativeforotherpathogensbycultureormicroscopy?(CSFPTHGN) 110.IsCSFnegativeformalignantcels?(CSFNMALC) DisseminatedFungalInfection: 111.Papularornodularskinlesionswithoutanyotherexplanation?(SKNLSNS) 112.Intraocularfindingssuggestiveofhematogenousfungalchorioretinitisor endophthalmitis?(ocular) ChronicDisseminatedCandidiasis: 113.Smal,peripheral,target-likeabscesses(bul's-eyelesions)inliverand/or spleen:(bullseye) 1-2- 3-3-NotApplicable 114.Recordmethodofdemonstratingabscesses:(CANDEVAL) 1-1-CTScan 2-2-MRI 3-3-Ultrasound MostRecentValue ULN foryourinstitution DateValueObtained 115. Serum AlkalinePhosphatase: (ALKPHOS) (xxx) U/L (ALKULN) (xxx) U/L (ALKPHSDT) (mm/dd/yyyy) Comments:(FIN1COMM)
AdditionalSelectionOptionsforFIN Recordorganism: 06-06-HistoplasmaSpecies 07-07-Fusarium Species 08-08-Mold(NOS) 09-09-CandidaAlbicans 10-10-CandidaKrusei 11-11-CandidaParapsilosis 12-12-CandidaTropicalis 13-13-CandidaGlabrata/TorulopsisGlabrata 14-14-Candida(NOS) 15-15-CryptococcusSpecies 16-16-Yeast(NOS) 17-17-Mucormycosis/Zygomycetes 99-99-Other Recordbiopsy/needleaspiratesite: 06-06-CentralNervousSystem Unspecified 00 -GastrointestinalTract - 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 15-15-Peritoneum 16-16-Liver 17-17-GastrointestinalTractUnspecified 00 -RespiratoryTract - 18-18-UpperAirwayandNasopharynx 19-19-Larynx 20-20-LowerRespiratoryTract(Lung) 21-21-PleuralCavity,PleuralFluid 22-22-Sinuses 23-23-RespiratoryTractUnspecified 00 -Genito-UrinaryTract - 24-24-Kidneys,RenalPelvis,UretersandBladder 25-25-Prostate 26-26-Testes 27-27-FalopianTubes,Uterus,Cervix 28-28-Vagina 29-29-Genito-UrinaryTractUnspecified 00 -Skin - 30-30-GenitalArea 31-31-Rash,Pustules,orAbscessesNotTypicalofAnyoftheAbove 32-32-SkinUnspecified 00 -Other - 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 Recordculturesite: 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 Recordspecimentype: 6-6-BronchoalveolarLavageFluid 7-7-Tissue 8-8-Fluid 9-9-Feces/Stool Recordculturesite: 9-9-Other Recordthenew infiltrate: 9-9-Other Recordradiologicevidence: 6-6-Other
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.Hasthepatientbeentreatedforprogression/relapse?(RELAPSTX) 5.Datetreatmentadministered:(TREATDT) (mm/dd/yyyy) 6.Indicatetypeoftreatment:(TREATYPE) 1-1-DLI 2-2-PBSCs 3-3-Chemotherapy 4-4-Radiation 5-5-SecondTransplant Specifyothertreatment:(FUS1SPEC) 7.Hasthepatientexperiencedsecondarygraftfailure?(SECGRFAL) 8.Hasthepatientexperiencedsecondarygraftfailure?(SECGRFAL) IfYes,aSecondaryGraftFailureForm mustbesubmited. 9.Dateofsecondarygraftfailure:(SCGRFLDT) (mm/dd/yyyy) 10.Dateofsecondarygraftfailure:(SCGRFLDT) (mm/dd/yyyy) 11. 12.Hasthepatientexperiencedanynew clinicalysignificantinfections?(newinfx) 13.Didthepatientexperienceapossible,probable,presumptive,orproven fungalinfection?(fusfungl) IfYes,aFungalInfectionForm mustbesubmited. 14.Dateoffungalinfection:(FNGLINDT) (mm/dd/yyyy) 15.Didthepatientexperienceanynon-fungalinfections?(FUSNONFN) 16.Dateofnon-fungalinfection:(NONFNGDT) IfYes,anInfectionForm mustbesubmited. (mm/dd/yyyy) 17.Hasthepatientbeenhospitalized?(HOSPITAL) IfYes,aRe-AdmissionForm mustbesubmited. 18.Dateofhospitalization:(HOSPTLDT) (mm/dd/yyyy) 19.Hasthepatientreceivedanon-protocolspecifiedtransplant?(TRANSTWO) 20.Dateofnon-protocolspecifiedtransplant:(DATRANSP) (mm/dd/yyyy) 21.Hasthepatientbeenprematurelypermanentlywithdrawnfrom thestudydrugprior today100(orday180)?(withdraw) IfYes,aPrematurePermanentWithdrawalForm mustbesubmited. 22.Dateofprematurepermanentwithdrawal:(WTHDRWDT) (mm/dd/yyyy) 23.Hasthepatientbeengivenanysystemicfungalprophylaxismedicationotherthan protocolstudydrugduringtheassessmentperiod?(prophmed) 24.WilthepatientcontinueonstudydruguntilDay180forprotocol-specified reasons?(contstdr) IfYes,aNon-StudyDrugProphylaxisForm mustbesubmited.
Comments:(FUS1COMM)
AdditionalSelectionOptionsforFUS Indicatetypeoftreatment: 6-6-OtherCelularTherapy 7-7-Other
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateGM SampleDrawn(GMEDTSD): DiagnosticGM AssayForm -EventDrivenSamples(GME) WebVersion:1.0;3.00;04-20-09 RecordtheresultoftheeventdrivendiagnosticGM assayblooddraw.eventdrivendiagnosticgm Assaysamplesshouldbedrawnattheonsetofapossible fungalinfectionandduringanempiricaltrialofamphotericinb. 1.Recordresult:(GMERESLT) 1-Positive 2-Negative 2.Recordindexvalue(s)ifavailable:(GMEINXV1) (x.xx) (GMEINXV2) (x.xx) Note:Ifasampleispositive,twoindexvalues(onefortheinitialandonefortherepeattest)oftheSAME samplearerequiredtobereportedifavailable. Comments:(GMECOMM1)
BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): VisitNumber(VISNO): DiagnosticGM AssayForm -ScheduledSamples(GMS) WebVersion:1.0;4.00;04-20-09 1.IsthepatientarecipientofaTceldepletedtransplantandreceived post-transplantgvhd prophylaxis,orcurentlytakingsteriods,or hasorhas hadacutegvhd requiringsystemictherapy?(freqcond) Recordtheresult(s)ofthescheduleddiagnosticGM assayblooddraw(s)forthepreviousweek. RecordtheresultofthebaselinediagnosticGalactomannanAssaysampledrawnpriortotheinitiationofconditioning. 1 st WeeklySample: 2Ṙecorddateof1 st weeklyblooddraw:(bldrwdt1) (mm/dd/yyyy) 3.Recorddateofbaselineblooddraw:(BSLBDDT1) (mm/dd/yyyy) 4.Recordresult:(GMRESLT1) 1-Positive 2-Negative 5.Recordindexvalue(s)ifavailable:(GMSINXV1) (x.xx) (GMSINXV2) (x.xx) Note:Ifasampleispositive,twoindexvalues(onefortheinitialandonefortherepeattest)oftheSAME samplearerequiredtobereportedifavailable. 2 nd WeeklySample: 6 Ṙecorddateof2 nd weeklyblooddraw:(bldrwdt2) (mm/dd/yyyy) 7.Recordresult:(GMRESLT2) 1-Positive 2-Negative 8.Recordindexvalue(s)ifavailable:(GMSINXV3) (x.xx) (GMSINXV4) (x.xx) Note:Ifasampleispositive,twoindexvalues(onefortheinitialandonefortherepeattest)oftheSAME samplearerequiredtobereportedifavailable. Comments:(COMMENTS)
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) Theassessmentforwhichyouareenteringdatamusthavetakenplacewithintheabovedates.Ifthepatientwasnotseenduringtheassessmentperiodspecifiedabove, pleaseexittheform andrequestanexceptionforthisform. 2.Immunosuppressant(prophylaxis)received:(IMMUNORC) 0-0-Prednisone 1-1-Cyclosporine 2-2-Tacrolimus 3-3-Nottakenduringassessment 3.Recordmostrecentbloodlevelofimmunosuppressant (prophylaxis):(troughlv) (xxxx.x) ng/ml 4.Recorddatebloodsampleobtained:(TROUGHDT) (mm/dd/yyyy)? Recordthehighestleveloforganabnormalities,theetiologiescontributingtotheabnormalitiesandanybiopsyresultsduringtheassessmentperiod. 5.Skinabnormalities:(GVHSKINA) 6.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) 7.SkinbiopsyforGVHD:(GVHSKINB) 3-3-Equivocal 4-4-NotDone 8.UpperGIabnormalities:(GVHUPGIA) 0-0-NoProtractedNauseaandVomiting 1-1-PersistentNausea,VomitingorAnorexia 9.Upperintestinaltractetiologies: GVHD DrugReaction ConditioningRegimenToxicity (UGIETGVH) (UGIETDRG) (UGIETCON) TPN Infection Other (UGIETTPN) (UGIETINF) (UGIETOTH) Specifyotherupperintestinaltractetiologies:(UGIETSPC)
10.UpperintestinaltractbiopsyforGVHD:(UGIBIORS) 3-3-Equivocal 4-4-NotDone 11.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? 12.Lowerintestinaltractetiologies: UsemL/dayforadultpatientsandmL/m 2 forpediatricpatients GVHD DrugReaction ConditioningRegimenToxicity (LGIETGVH) (LGIETDRG) (LGIETCON) TPN Infection Other (LGIETTPN) (LGIETINF) (LGIETOTH) Specifyotherlowerintestinaltractetiologies:(LGIETSPC) 13.LowerintestinaltractbiopsyforGVHD:(LGIBIORS) 3-3-Equivocal 4-4-NotDone 14.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 15.Liveretiologies: GVHD DrugReaction ConditioningRegimenToxicity TPN (LIVETGVH) (LIVETDRG) (LIVETCND) (LIVETTPN) Infection VOD Other (LIVETINF) (LIVETVOD) (LIVETOTH) Specifyotherliveretiologies:(GVHLIVRS) 16.LiverbiopsyforGVHD:(GVHLIVRB) 3-3-Equivocal 4-4-NotDone ')} ThisonlyappliestoTREATMENTforGVHD.IfGVHD prophylaxiswastheonlymodificationduringthisassessmentperiod,thisquestionshouldbeanswered"". 17.Ifyes,specifyagentname:(GVHAGENT) 1-1-CSA 2-2-FK506 3-3-TopicalSteroids 4-4-Prednisone 5-5-ATG Specifyotheragent:(GVHAGNSP)
18.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) 3.WasaCD4countperformed?(CD4DONE) 4.Datespecimencolected:(CD4DATE) (mm/dd/yyyy) 5.Results:(CD4COUNT) (xxxx) perul RecordChimerism AssayDataforMarrow and/orblood Marow 6.Wasachimerism performedonamarowsample?(mrwdone) 7.Datespecimencolected:(MRWDT2) (mm/dd/yyyy) 8.Methodofevaluation:(MTHOD1) 1-1-StandardCytogenetics 2-2-FluorescentInSituHybridization(FISH) 3-3-RestrictionFragment-LengthPolymorphisms(RFLP) 4-4-PolymeraseChainReaction(PCR) 5-5-HLASerotyping Specifyother:(MRWSPEC) 9.Celtype:(MRWCLTYP) 1-Unmanipulated 2-Granulocytes 10.Marowassayresults:(MRWASSAY) 1-1-AlHostCels 2-2-AlDonorCels 3-3-HostandDonor 11.% Donor:(PCNTDNR1) (xx) % Blood 12.Wasachimerism performedonabloodsample?(blddone) 13.Datespecimencolected:(BLDCHMDT) (mm/dd/yyyy) 14.Methodofevaluation:(MTHOD2) 1-1-StandardCytogenetics 2-2-FluorescentInSituHybridization(FISH) 3-3-RestrictionFragment-LengthPolymorphisms(RFLP) 4-4-PolymeraseChainReaction(PCR) 5-5-HLASerotyping Specifyother:(BLDSPEC) 15.Celtype:(BLDCLTYP) 16.Bloodassayresults:(BLDASSAY) 1-Unmanipulated 1-1-AlHostCels 2-2-AlDonorCels 3-3-HostandDonor 2-Granulocytes 17.% Donor:(PCNTDNR2) (xx) % TCelChimerism