Re-Admission/HospitalizationForm (ADM)

Transcription

1 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofAdmission(ADMITDT): Re-Admission/HospitalizationForm (ADM) WebVersion:1.0;4.02; Dateofdischarge:(DISCHDT) (mm/dd/yyyy) 2.Patientdischargestatus:(DISCPTST) 1-Alive 2-Dead IfDead,aDeathForm mustbesubmited. 3.RecordPRIMARYdischargediagnosis:(PHSPREAS) *Specifyorgan:(ADM4SPEC) **Specifyother:(ADM1SPEC) GVHD Relapse/Progression GraftFailure Infection 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)

2 AdditionalSelectionOptionsforADM RecordPRIMARYdischargediagnosis: Non-FungalInfection Fever Seizure Bleeding/Hemorhage Diarhea Nausea/Vomiting OrganFailure(specifyorgan)* Trauma Psychiatric SecondaryMalignancy Transplant ScheduledProcedure/Treatment Thrombosis/Thrombus/Embolism Other(specify)**

3 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): Unexpected,Grade3-5AdverseEventForm (AE1) WebVersion:1.0;3.06; 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??

4 Comments:(AE1COMM)

5 AdditionalSelectionOptionsforAE1 Wasthiseventassociatedwith: 5-5-RequiredInterventiontoPreventPermanentImpairmentorDamage 6-6-Hospitalization(InitialorProlonged) 9-9-OtherSAE

6 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): SummaryForm -Unexpected,Grade3-5AdverseEvent(AE2) WebVersion:1.0;3.06; 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)?

7 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): TherapyForm -Unexpected,Grade3-5AdverseEvent(AE3) WebVersion:1.0;3.06; 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)

8 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

9 (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)

10 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): Laboratory/DiagnosticsForm -Unexpected,Grade3-5AdverseEvent(AE4) WebVersion:1.0;3.05; 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

11 (ADDTS1) (AD1DTDAT) (AD1DTRES) (ADDTS2) (AD2DTDAT) (AD2DTRES) (ADDTS3) (AD3DTDAT) (AD3DTRES) (ADDTS4) (AD4DTDAT) (AD4DTRES) (ADDTS5) (AD5DTDAT) (AD5DTRES)

12 (ADDTS6) (AD6DTDAT) (AD6DTRES) (ADDTS7) (AD7DTDAT) (AD7DTRES) (ADDTS8) (AD8DTDAT) (AD8DTRES) (ADDTS9) (AD9DTDAT) (AD9DTRES) (ADDTS10) (AD10DTDT) (AD10DTRS)

13 Comments:(AE4COMM)

14 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): Review Form -Unexpected,Grade3-5AdverseEvent(AE5) WebVersion:1.0;3.06; 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)

15 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateofOnset(ADVDATE): Eventdescription(ADVENT): MedicalMonitorReviewerForm -Unexpected,Grade3-5AdverseEvent(AE6) WebVersion:1.0;5.00; 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)

16 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): VisitNumber(VISNO): Folow UpGVHD Form (CGV) WebVersion:1.0;7.03; 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) 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)?

17 15.Minimum Karnofsky/LanskyScoreattimeof diagnosis:(cgvkrnln) (Normal;NoComplaints/FulyActive) (NormalActivity/MinorRestrictioninStrenuousPlay) (NormalActivitywithEfort/RestrictedinStrenuousPlay) (UnabletoCaryOnNormalActivity/LessTimeSpentinPlay) (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 % 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) % 1-1-<90-75% 2-2-<75-50% 3-3-<50-25% 4-4-<25%

18 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/dayor mL/m^2 3-3-Diarhea>1000butLessThanorEqualto1500mL/dayor mL/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-Bilirubin mg/dL 2-2-Bilirubin mg/dL 3-3-Bilirubin mg/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)

19 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.

20 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

21 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) (Normal;NoComplaints/FulyActive) (NormalActivity/MinorRestrictioninStrenuousPlay) (NormalActivitywithEfort/RestrictedinStrenuousPlay) (UnabletoCaryOnNormalActivity/LessTimeSpentinPlay) (RequiresOccasionalAssistance/MinimalActivePlay) 57.Curentplateletcount:(CURPLTCT) (xxx.x) x10 9 /L 58.Curentweight:(CURWGHT) (xxx.x) kg Comments:(CGVCOMM)

22 AdditionalSelectionOptionsforCGV Minimum Karnofsky/LanskyScoreattimeofdiagnosis: (RequiresConsiderableAssistance/NoActivePlay) (Disabled/AbletoInitiateQuietActivities) (SeverelyDisabled/NeedsAssistanceforQuietPlay) (VerySick/LimitedtoVeryPassiveActivity) (Moribund;CompletelyDisabled) BiopsyType1 6-6-LungBiopsy 7-7-Other,Specify CurentKarnofsky/LanskyScore: (RequiresConsiderableAssistance/NoActivePlay) (Disabled/AbletoInitiateQuietActivities) (SeverlyDisabled/NeedsAssistanceforQuietPlay) (VerySick/LimitedtoVeryPassiveActivity) (Moribund;CompletelyDisabled) (Dead)

23 BloodandMarrow TransplantClinical TrialsNetwork Demographics(DEM) WebVersion:1.0;6.00; 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 White(NotOtherwiseSpecified) European(NotOtherwiseSpecified) Mediteranean WhiteNorthAmerican Specifyrace:(RACESP) 8.SecondaryRace:(RACE2) -White White(NotOtherwiseSpecified) European(NotOtherwiseSpecified) Mediteranean WhiteNorthAmerican Specifysecondaryrace:(RACE2SP) Comments:(DEMCOMM1)

24 AdditionalSelectionOptionsforDEM Race: SouthorCentralAmerican EasternEuropean NorthernEuropean WesternEuropean WhiteCaribbean 82-8rthCoastofAfrica MiddleEastern -Black Black(NotOtherwiseSpecified) AfricanAmerican AfricanBlack(BothParentsBorninAfrica) CaribbeanBlack SouthorCentralAmericanBlack Black,OtherSpecify -Asian Asian(NotOtherwiseSpecified) Indian/SouthAsian Filipino(Pilipino) Japanese Korean Chinese OtherSoutheastAsian Vietnamese -AmericanIndianorAlaskaNative NativeAmerican(NotOtherwiseSpecified) NativeAlaskan/Eskimo/Aleut AmericanIndian(NotOtherwiseSpecified) NorthAmericanIndian SouthorCentralAmericanIndian CaribbeanIndian -NativeHawaianorOtherPacificIslander NativePacificIslander(NotOtherwiseSpecified) Guamanian Hawaian Samoan -Other Unknown Other,Specify NotAnswered

25 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): SampleEvents(SAMPEVEN): DateEventOccurred(DATOCCRD): SpecimenAcquisitionsForm -Event-DrivenSamples(EDS) WebVersion:1.0;4.01; 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)

26 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)

27 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

28 BloodandMarrow TransplantClinical TrialsNetwork 0101B(ENR) WebVersion:1.0;3.00; 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)

29 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): InfectionStartDate(INFSTDT): FungalInfectionForm (FIN) WebVersion:1.0;5.00; 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) AspergilusFlavus AspergilusFumigatus AspergilusNiger AspergilusTereus Aspergilus(NOS) Specifyother:(DTORGSPC) 5.Recordbiopsy/needleaspirateresults:(DTBIOPSY) 3-3-NotDone 6.Recordbiopsy/needleaspiratesite:(DTBIOPST) Disseminated-Generalized,Isolatedat2orMoreDistinctSites 00 -CentralNervousSystem Brain SpinalCord 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) Blood/BufyCoat Disseminated-Generalized,Isolatedat2orMoreDistinctSites Brain SpinalCord MeningesandCSF Ifdisseminated,recordthe2ormorepositivesites:(DTDISCLT)

30 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) AspergilusFlavus AspergilusFumigatus AspergilusNiger AspergilusTereus 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

31 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 mg/kg/day 4-4->2mg/kg/day (mm/dd/yyyy) (mm/dd/yyyy) 3weekspriortoinfectionstartdate:(AVGDSDT) MicrobiologicalFactors

32 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)

33 73.Candidacastsinurineinabsenceofurinarycatheter?(CANDIDAU) 3-3-NotDone ClinicalFactors Indicateifthepatientmeetsanyoftheclinicalfactorsbelow: LowerRespiratoryTractInfection: 74.New infiltratesdetectedbyctimaging?(newinflt) 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) 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:

34 99.RadiologicalevidencesuggestingCNSinfection?(CNSRAD) 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) 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) 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)

35 AdditionalSelectionOptionsforFIN Recordorganism: HistoplasmaSpecies Fusarium Species Mold(NOS) CandidaAlbicans CandidaKrusei CandidaParapsilosis CandidaTropicalis CandidaGlabrata/TorulopsisGlabrata Candida(NOS) CryptococcusSpecies Yeast(NOS) Mucormycosis/Zygomycetes Other Recordbiopsy/needleaspiratesite: CentralNervousSystem Unspecified 00 -GastrointestinalTract Lips Tongue,OralCavity,andOro-Pharynx Esophagus Stomach GalbladderandBiliaryTree(NotHepatitis),Pancreas SmalIntestine LargeIntestine Peritoneum Liver GastrointestinalTractUnspecified 00 -RespiratoryTract UpperAirwayandNasopharynx Larynx LowerRespiratoryTract(Lung) PleuralCavity,PleuralFluid Sinuses RespiratoryTractUnspecified 00 -Genito-UrinaryTract Kidneys,RenalPelvis,UretersandBladder Prostate Testes FalopianTubes,Uterus,Cervix Vagina Genito-UrinaryTractUnspecified 00 -Skin GenitalArea Rash,Pustules,orAbscessesNotTypicalofAnyoftheAbove SkinUnspecified 00 -Other Woundsite CatheterTip Eyes Ears Joints BoneMarow BoneCortex(Osteomyelitis) Muscle(ExcludingCardiac) Cardiac(Endocardium,Myocardium,Pericardium) LymphNodes Spleen OtherUnspecified Recordculturesite: CentralNervousSystem Unspecified Lips Tongue,OralCavity,andOro-Pharynx Esophagus Stomach GalbladderandBiliaryTree(NotHepatitis),Pancreas SmalIntestine LargeIntestine Feces/Stool Peritoneum Liver GastrointestinalTractUnspecified UpperAirwayandNasopharynx Larynx LowerRespiratoryTract(Lung) PleuralCavity,PleuralFluid Sinuses RespiratoryTractUnspecified Kidneys,RenalPelvis,UretersandBladder Prostate Testes FalopianTubes,Uterus,Cervix Vagina Genito-UrinaryTractUnspecified

36 30-30-GenitalArea Rash,Pustules,orAbscessesNotTypicalofAnyoftheAbove SkinUnspecified Woundsite CatheterTip Eyes Ears Joints BoneMarow BoneCortex(Osteomyelitis) Muscle(ExcludingCardiac) Cardiac(Endocardium,Myocardium,Pericardium) LymphNodes Spleen 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

37 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): VisitNumber(VISNO): Folow UpStatusForm (FUS) WebVersion:1.0;12.01; 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) 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.

38 Comments:(FUS1COMM)

39 AdditionalSelectionOptionsforFUS Indicatetypeoftreatment: 6-6-OtherCelularTherapy 7-7-Other

40 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): DateGM SampleDrawn(GMEDTSD): DiagnosticGM AssayForm -EventDrivenSamples(GME) WebVersion:1.0;3.00; 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)

41 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): VisitNumber(VISNO): DiagnosticGM AssayForm -ScheduledSamples(GMS) WebVersion:1.0;4.00; 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)

42 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): VisitNumber(VISNO): AcuteGVHDForm (GVH) WebVersion:1.0;10.04; 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)

43 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/dayor mL/m^2 3-3-Diarhea>1000butLessThanorEqualto1500mL/dayor mL/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-Bilirubin mg/dL 2-2-Bilirubin mg/dL 3-3-Bilirubin mg/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-FK TopicalSteroids 4-4-Prednisone 5-5-ATG Specifyotheragent:(GVHAGNSP)

44 18.Indicatetreatmentmodification:(GVHTRMOD) 1-1-Started 2-2-Stopped 4-4-Tapered 5-5-Increased Comments:(GVHCOMM)

45 AdditionalSelectionOptionsforGVH LowerGIabnormalities: 5-5-SevereAbdominalPainwithorwithoutIleus,orStoolwithFrankBloodorMelena Ifyes,specifyagentname: 6-6-MMF 7-7-Daclizumab 8-8-Methylprednisolone 9-9-Other

46 BloodandMarrow TransplantClinical TrialsNetwork Segment(PROTSEG): VisitNumber(VISNO): MyeloablativeHematopoiesisForm (HEM) WebVersion:1.0;7.01; 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