Public Use Dataset Annotated ecrf

Transcription

1 Public Use Dataset Annotated ecrf Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (Magnesium in Crisis (MAGiC)) PECARN Protocol Number 025 Pediatric Emergency Care Applied Research Network National Institute for Child Health and Human Development (NICHD) Protocol Version 1.05 Version Date: September 7, 2012 PUD Annotated ecrf Version 1.0 Version Date: March 27,

2 Table of Contents: Annotations key:... 4 Notes:... 5 MAGiC Patient Eligibility:... 6 MAGiC Patient Demographics:... 9 MAGiC Patient Randomization: MAGiC Previous Medical History & History of Illness: MAGiC Baseline Information: MAGiC Physical Exam: MAGiC Daily Data Collection: MAGiC Study Drug Administration 1 st Infusion: MAGiC Study Drug Administration 2 nd Infusion: MAGiC Study Drug Administration 3 rd Infusion: MAGiC Study Drug Administration 4 th Infusion: MAGiC Study Drug Administration 5 th Infusion: MAGiC Study Drug Administration 6 th Infusion: MAGiC Adverse Events Log: MAGiC Concomitant Medications Log: MAGiC Opioid Log: MAGiC Ketorolac Log: MAGiC Blood Transfusion Log: MAGiC Magnesium Log: MAGiC Serious Adverse Event Report: MAGiC Study Summary: MAGiC Telephone Follow-up: MAGiC Telephone Follow-up Ages 4-18: MAGiC Telephone Follow-up Ages 19-21: MAGiC Follow-Up Visit: MAGiC Blood Transfusions Post Hospital Discharge: MAGiC Day 28 Patient Mortality:

3 MAGiC Withdrawal of Consent: Biomarkers: Pain Scores: QL Scores: MAGIC Peds Quality of Life Family Information Form Ages 4-18: MAGIC Peds Quality of Life Adult Patient Information Form Ages 19-21: MAGIC PedsQL Parent Report for Toddlers (age 4): MAGIC PedsQL Parent and Young Child Report (age 5-7): MAGiC PedsQL Child and Parent QOL Survey Dates: MAGiC PedsQL Parent and Child Report (ages 8-12): MAGiC PedsQL Parent and Teen Report (ages 13-18): MAGiC PedsQL Young Adult Report (ages 19-21):

4 Annotations key: Table name Column name followed by: # or $N # = numeric $N = character N = length Format (name) Code list Calculated / Derived variable Table name_child table name Variable in question group 4

5 Notes: StudySubjectID is the original identifier. A new masked identifier named PudId has been created; this variable is present in all datasets to facilitate merging. We will retain a dataset that links the original StudySubjectID to the PudID for internal records. After the new masked identifier is created and used to replace the original, each public use dataset is sorted by its unique identifier(s). This will ensure that the final sorting of records does not correspond to the ordering of the original identifier. All out of range and other questionable data has been included in the public use datasets. Sensitive and/or identifying information entered in free text fields has been modified as needed or removed from the public use datasets. All date variables are recoded to be number of days since emergency department (ED) arrival. Variable names and labels are changed as well. For example, the variable AEStartDate will be called AEStartDay and the label will change from Adverse Event Start Date to Adverse Event Start Day (relative to ED arrival). No actual dates will be included. Many of the datasets include only one record per subject (unique identifier PudId). Other datasets are relational, that is, may have more than one record per subject. These records are uniquely identified by PudId and ItemGroupRepeatKey, PudId and Occurrence, or a combination of PudId, ItemGroupRepeatKey, and Occurrence. The datasets are primarily based on raw datasets (i.e., as captured in study database with minimal modifications). Selected derived data elements will also be included, namely transformed QL scores. 25 Hr Magnesium Levels: This data is only available for a subset of subjects (those enrolled prior to v1.04 of protocol). The purpose of collecting this data, originally, was to confirm that the magnesium dose administered was not an unsafe dose amount. The DSMB approved the discontinuation of the collection of these data (Protocol: v1.04+). 5

6 Eligibility (1 of 3) MAGiC Patient Eligibility: EDDay, # EDTime, $5 ScreenDay, # Inclusion1, # Inclusion2, # YesNo Inclusion3, # Inclusion4, # Exclusion1, # Exclusion2, # Exclusion3, # Exclusion4, # Exclusion5, # YesNo Exclusion6, # Exclusion7, # Exclusion8, # Exclusion9, # 6

7 Eligibility (2 of 3) Exclusion10, # Exclusion11, # Exclusion12, # Exclusion13, # Exclusion14, # Exclusion15, # Exclusion16, # YesNo Exclusion17, # Exclusion18, # Exclusion20, # Exclusion21, # Exclusion22, # 7

8 Eligibility (3 of 3) Eligibility, # YesNo PreConsentGiven, # YesNoS ConsentApproach, # YesNoS ConsentDay, # Consent, # YesNoS ConsentTime, $5 AssentTm 1 = In the clinic (prior to current hospitalization) 2 = In the ED or on the floor but prior to randomization 3 = After randomization but prior to last study drug infusion 4 = After the last study drug infusion but prior to hospital discharge 5 = At the time of follow-up AssentApproach, # YesNoS AssentTimeApproach, # YesNoS Assent, # AssentDay, # AssentTime, $5 LaterIneligible, # YesNo 8

9 Demographics (1 of 1) MAGiC Patient Demographics: Age, # Sex, # Sex 1 = Male 2 = Female Ethnicity, # Ethnic 1 = Hispanic or Latino 2 = Not Hispanic or Latino 92 = Unknown or Not Reported NIHRace, # NIHRace 1 = American Indian or Alaska Native 2 = Asian 3 = Black or African American 4 = Native Hawaiian or Other Pacific Islander 5 = White 6 = Multi-race 92 = Unknown or Not Reported 9

10 Randomization (1 of 2) MAGiC Patient Randomization: PtRandomized, # YesNo NotRandReason, # NotRandReasonOther, $108 StratifyAge, # HydroxyureaUse, # Strat 1 = 4 to 11 years of age 2 = 12 to 21 years of age YesNoS RandDay, # RandTime, $5 NoRand 1 = Patient had received IV opioid medication for greater than 12 hours before randomization could be accomplished 2 = Patient developed other exclusion criteria before randomization could be accomplished 3 = Withdrawal of consent prior to randomization 90 = Other reason (specify) 10

11 Randomization (2 of 2) Variable Format Type Label Algorithm / Notes AssignedTreatmentGroup Which treatment was the patient TrtFmt # assigned to? Which treatment did the patient ReceivedTreatmentGroup TrtFmt # receive? RandomizationAge # Age (in years) at Randomization ITT YesNo # PerProtocol YesNo # SafetyPopulation YesNo # Is the patient in the ITT Population? Is the patient in the Per Protocol population? Is the patient in the safety population? Strata $2 Treatment Strata TrtFmt 1 = Placebo 0 = Magnesium YesNo 11

12 MedHistory (1 of 3) MAGiC Previous Medical History & History of Illness: HistoryACS, # HistoryAsthma, # YesNoUk 92 = Unknown YesNo HistoryPainCrisis, # PainCrisisVisits, # YesNoS ClinicVisit, # ClinicDay, # ClinicSBP, # MedianHeight, # MedianSBP, # 12

13 MedHistory (2 of 3) MHDay, # MHTime, $5 MHHEENT, # MHCardio, # MHRespPulm, # MHGI, # MHHepatic, # NormAbUk 1 = Normal 2 = Abnormal 92 = Unknown MHGenitourine, # 13

14 MedHistory (3 of 3) MHRenal, # MHNeuro, # MHPsych, # MHEndo, # NormAbUk 1 = Normal 2 = Abnormal 92 = Unknown MHHeme, # MHMusculo, # MHDerm, # 14

15 Baseline (1 of 3) MAGiC Baseline Information: AdmitDay, # AdmitTime, $5 VSDay, # VSTime, $5 Temperature, # RespRate, # HeartRate, # SBP, # DBP, # PulseOx, # Baseline_BaseHemLabs HemLabDay, # HemLabTime, $5 Hematocrit, # Hemoglobin, # WBC, # Platelets, # Reticulocytes, # Baseline_BaseElecLabs ElecLabDay, # ElecLabTime, $5 Sodium, # Potassium, # Chloride, # Bicarb, # BUN, # Creatinine, # Baseline_BaseChemLabs ChemLabDay, # ChemLabTime, $5 Calcium, # Magnesium, # LDH, # 15

16 Baseline (2 of 3) OPNonOpioidTaken, # YesNo CodedOPNonOpioidName, $255 NonCodedOPNonOpioidName, $29 OPNonOpioidDay, # Baseline_OPNonOpioid OPNonOpioidTime, $5 OPOpioidTaken, # OPOpioidDose, # YesNo OPOpioidName, # OPOpioidNameOther, $255 OPOpioidDay, # OPOpioidTime, $5 OPOpioidDoseUnit, # OPOpioidDoseUnitOther, $4 Baseline_OPOpioid DoseUnit 1 = mg 2 = mcg 90 = other EDNonOpioidTaken, # Baseline_EDNonOpioid YesNo CodedEDNonOpioidName, $255 EDNonOpioidDay, # EDNonOpioidTime, $5 NonCodedEDNonOpioidName, $65 EDMedNam 1 = Morphine 2 = Morphine SR 3 = Hydromorphone 4 = Fentanyl 5 = Codeine 6 = Oxycodone 90 = Other (specify) 16

17 Baseline (3 of 3) EDOpioidTaken, # YesNo EDOpioidName, # EDOpioidNameOther, $255 EDOpioidStartDay, # EDOpioidStartTime, $5 EDOpioidStopDay, # EDOpioidDoseBasal, # EDOpioidDoseUnit, # EDOpioidRoute, # EDOpioidStopTime, $5 EDOpioidDoseDemand, # EDOpioidDoseUnitOther, $201 Baseline_EDOpioid EDMedNam 1 = Morphine 2 = Morphine SR 3 = Hydromorphone 4 = Fentanyl 5 = Codeine 6 = Oxycodone 90 = Other (specify) DoseUnit 1 = mg 2 = mcg 90 = other EDRoute 1 = Continuous IV (Including PCA) 2 = Intermittent IV Bolus 3 = Oral 17

18 PhysicalExam (1 of 2) MAGiC Physical Exam: DiseaseType, # OnsetPainDate, # DzType 1 = Sickle Cell Anemia 2 = Sickle Beta-Zero DateSick 1 = Today 2 = Yesterday 3 = 2 days ago 4 = 3 days ago 5 = 4 days ago 6 = 5 days ago 7 = Greater than 5 days ago PEDay, # PETime, $5 PEWeight, # PEHEENT, # PECardio, # PERespPulm, # PEGI, # NormAbAs 1 = Normal 2 = Abnormal 99 = Not assessed PEHepatic, # PEGU, # 18

19 PhysicalExam (2 of 2) PERenal, # PENeuro, # PEPsych, # PEEndo, # PEHeme, # NormAbAs 1 = Normal 2 = Abnormal 99 = Not assessed PEMusculo, # PEDerm, # PhysioGroup, # PhysioG 1 = Simple crisis (no fever; no ACS) 2 = Pain with fever on arrival in ED (no ACS) 3 = Pain crisis, developed ACS at any time 4 = Did not have a pain crisis 19

20 DailyData (1 of 2) MAGiC Daily Data Collection: DailyDay, # DailyWeakness, # DailyDizziness, # DailyCough, # DailyOtherNewSymp, # DailyConMed, # YesNo DailyOpioid, # DailyKetorolac, # DailyTrans, # DailyACS, # DailyPriapism, # DailyStroke, # DailyOtherMajorEvents, # 20

21 DailyData (2 of 2) HemLabDrawn, # DailyData_HemLabs HemLabDay, # HemLabTime, $5 Hematocrit, # Hemoglobin, # WBC, # Platelets, # Reticulocytes, # ElecLabDrawn, # DailyData_ElecLabs ElecLabDay, # ElecLabTime, $5 Sodium, # Potassium, # Chloride, # Bicarb, # BUN, # Creatinine, # ChemLabDrawn, # DailyData_ChemLabs YesNo ChemLabDay, # ChemLabTime, $5 Calcium, # LDH, # 21

22 DrugAdmin1 (1 of 1) MAGiC Study Drug Administration 1 st Infusion: WhyNoMedAdmin, # MedAdminHappen, # YesNo InfusionStartDay, # InfusionStopDay, # InfusionStartTime, $5 InfusionStopTime, $5 InfusionDose, # InfusionSlowed, # DrugAdmin1_VS1 VSDay, # VSTime, $5 HeartRate, # SBP, # DBP, # PulseOx, # InfusionHypotension, # InfusionWarmth, # InfusionOther, # YesNoS NoWhy 1 = Patient has reached study endpoint (hospital discharge or 12 hours after last IV opioid administration) 90 = Other (specify) 22

23 DrugAdmin2 (1 of 1) MAGiC Study Drug Administration 2 nd Infusion: WhyNoMedAdmin, # MedAdminHappen, # YesNo InfusionStartDay, # InfusionStopDay, # InfusionStartTime, $5 InfusionStopTime, $5 InfusionDose, # InfusionSlowed, # DrugAdmin2_VS2 VSDay, # VSTime, $5 HeartRate, # SBP, # DBP, # PulseOx, # InfusionHypotension, # InfusionWarmth, # InfusionOther, # YesNoS NoWhy 1 = Patient has reached study endpoint (hospital discharge or 12 hours after last IV opioid administration) 90 = Other (specify) 23

24 DrugAdmin3 (1 of 1) MAGiC Study Drug Administration 3 rd Infusion: WhyNoMedAdmin, # MedAdminHappen, # YesNo InfusionStartDay, # InfusionStopDay, # InfusionStartTime, $5 InfusionStopTime, $5 InfusionDose, # InfusionSlowed, # DrugAdmin3_VS3 VSDay, # VSTime, $5 HeartRate, # SBP, # DBP, # PulseOx, # InfusionHypotension, # InfusionWarmth, # InfusionOther, # YesNoS NoWhy 1 = Patient has reached study endpoint (hospital discharge or 12 hours after last IV opioid administration) 90 = Other (specify) 24

25 DrugAdmin4 (1 of 1) MAGiC Study Drug Administration 4 th Infusion: MedAdminHappen, # YesNo WhyNoMedAdmin, # InfusionStartDay, # InfusionStopDay, # InfusionStartTime, $5 InfusionStopTime, $5 InfusionDose, # InfusionSlowed, # DrugAdmin4_VS4 VSDay, # VSTime, $5 HeartRate, # SBP, # DBP, # PulseOx, # InfusionHypotension, # InfusionWarmth, # InfusionOther, # YesNoS NoWhy 1 = Patient has reached study endpoint (hospital discharge or 12 hours after last IV opioid administration) 90 = Other (specify) 25

26 DrugAdmin5 (1 of 1) MAGiC Study Drug Administration 5 th Infusion: MedAdminHappen, # YesNo WhyNoMedAdmin, # InfusionStartDay, # InfusionStopDay, # InfusionStartTime, $5 InfusionStopTime, $5 InfusionDose, # InfusionSlowed, # DrugAdmin5_VS5 VSDay, # VSTime, $5 HeartRate, # SBP, # DBP, # PulseOx, # InfusionHypotension, # InfusionWarmth, # InfusionOther, # YesNoS NoWhy 1 = Patient has reached study endpoint (hospital discharge or 12 hours after last IV opioid administration) 90 = Other (specify) 26

27 DrugAdmin6 (1 of 1) MAGiC Study Drug Administration 6 th Infusion: MedAdminHappen, # YesNo WhyNoMedAdmin, # InfusionStartDay, # InfusionStopDay, # InfusionStartTime, $5 InfusionStopTime, $5 InfusionDose, # InfusionSlowed, # DrugAdmin6_VS6 VSDay, # VSTime, $5 HeartRate, # SBP, # DBP, # PulseOx, # InfusionHypotension, # InfusionWarmth, # InfusionOther, # morphine_equivalents, # YesNoS NoWhy 1 = Patient has reached study endpoint (hospital discharge or 12 hours after last IV opioid administration) 90 = Other (specify) 27

28 AdverseEvent (1 of 1) MAGiC Adverse Events Log: AdverseEvent AEName, $100 AEStartDay, # AEStopDay, # AEOutcome, # AEIntensity, # Outcome 1 = Death 2 = Recovered (patient returned to baseline) 3 = Recovered with sequelae 4 = Symptom persists Intense 1 = Mild 2 = Moderate 3 = Severe AdverseEvent AEActionTaken, # DrugRelationship, # AEExpected, # AESeverity, # Action 1 = Study medication infusion slowed 2 = Study medication discontinued 3 = Concomitant medication started, changed, or discontinued 4 = Surgery or other procedure 91 = None 90 = Other (describe) Relation 1 = Not related 2 = Possibly related 3 = Probably related Expect 1 = Expected 2 = Not Expected YesNo 28

29 MAGiC Concomitant Medications Log: ConMeds (1 of 1) ConMeds MedName, $255 MedDose, # MedDoseUnit, $13 MedStartDay, # ConMeds MedStopDay, # MedIndication, $50 MedContinue, # MedRelatedAE, # YesNo 29

30 Opioid_OpioidContinIV, Opioid_OpioidInterIV, Opioid_OpioidPO (1 of 2) MAGiC Opioid Log: Opioid_OpioidContinIV IVOpioidName, # IVOpioidNameOther, $255 IVOpioidStartDay, # IVOpioidStartTime, $5 IVOpioidStopDay, # IVOpioidStopTime, $5 MedName 1 = Morphine 2 = Hydromorphone 3 = Fentanyl 90 = Other (specify) Opioid_OpioidContinIV IVOpioidDoseBasal, # IVOpioidDoseDemand, # IVOpioidDoseUnit, # IVOpioidDoseUnitOther, S201 DoseUnit 1 = mg 2 = mcg 90 = other Opioid_OpioidInterIV BolusOpioidName, # BolusOpiodDay, # BolusOpioidTime, $5 BolusOpioidDoseUnit, # BolusOpioidNameOther, $255 BolusOpioidDose, # BolusOpioidDoseUnitOther, $201 30

31 Opioid_OpioidContinIV, Opioid_OpioidInterIV, Opioid_OpioidPO (2 of 2) Opioid_OpioidPO POOpioidName, # POOpioidNameOther, $255 POOpioidDay, # POOpioidTime, $5 POOpioidDose, # POOpioidDoseUnit, # POOpioidDoseUnitOther, $201 POName 1 = Morphine 2 = Morphine SR 3 = Hydromorphone 4 = Codeine 5 = Oxycodone 90 = other (specify) DoseUnit 1 = mg 2 = mcg 90 = other 31

32 Ketorolac (1 of 1) MAGiC Ketorolac Log: Ketorolac KetDay, # KetTime, $5 KetDose, # KetDoseUnitOther, $201 KetDoseUnit, # DoseUnit 1 = mg 2 = mcg 90 = other 32

33 Transfusion (1 of 1) MAGiC Blood Transfusion Log: Transfusion TypeBloodProductOther, $13 TransStartDay, # TransStartTime, $5 TransStopDay, # TransStopTime, $5 TransfusionVolume, # TypeBloodProduct, # TypeBlod 1 = Packed RBC 90 = other (specify) 33

34 Magnesium (1 of 1) MAGiC Magnesium Log: Mg4Day, # Mg4Time, $5 Magnesium4, # 34

35 SAE (1 of 2) MAGiC Serious Adverse Event Report: SAEIDDay, # SAEIDTime, $5 SAERepDay, # SAERepTime, $5 SAEName, $400 SAEOnsetDay, # SAEOnsetTime, $5 SAEResDay, # SAEResTime, $5 SAECriteria, # SAEAction, # SAE_Serious Criteria 1 = Death 2 = Life threatening 3 = Inpatient hospitalization 4 = Prolonged existing hospitalization 5 = Persistent or significant disability or incapacity 6 = Congenital abnormality or birth defect 90 = Other (specify) SAEAbate, # YesNoNA 96 = Not applicable SAEIntensity, # SAEOutcome, # Intense 1 = Mild 2 = Moderate 3 = Severe Outcome 1 = Death 2 = Recovered (patient returned to baseline) 3 = Recovered with sequelae 4 = Symptom persists Action 1 = Study medication infusion slowed 2 = Study medication discontinued 3 = Concomitant medication started, changed, or discontinued 4 = Surgery or other procedure 91 = None 90 = Other (describe) SAERelation, # Relation 1 = Not related 2 = Possibly related 3 = Probably related SAEExpected, # Expect 1 = Expected 2 = Not expected 35

36 SAE (2 of 2) MMReviewDay, # SAEDetail, # SAEProtocol, # SAEInformConsent, # SAEReinformConsent, # YesNo SAENotify, # SAEStudyCont, # NonSAE, # 36

37 StudySummary (1 of 1) MAGiC Study Summary: DischargeTime, $5 DischargeDay, # FirstIVOpioidTime, $5 FirstIVOpioidDay, # LastIVOpioidTime, $5 LastIVOpioidDay, # PtDrugAssess, # FinalDiagnosis, # FinalDiagnosisOther, $1513 YesNo DrugOn 1 = Magnesium 2 = Saline 92 = Patient does not know 99 = Not Asked 37

38 Phone (1 of 3) MAGiC Telephone Follow-up: PhoneOccur, # YesNo YesNoS ParentInterview, # ChildInterview, # Rehosp7day, # YesNoS RehospDay, # RehospTime, $5 RehospDischargeDay, # RehospSource, # Phone_PhoneRehos RehospLoc, # Rehos 1 = Study Hospital 2 = Other Hospital Unsched7day, # YesNoS UnschedDay, # UnschedLocOther, $201 UnschedLoc, # UnschedSource, # Phone_PhoneUnsched UnCare 1 = ED/Emergent Care 2 = Primary Care Physician office 3 = Clinic 90 = Other (specify) Source 1 = Parent 2 = Chart 3 = Parent & Chart 38

39 Phone (2 of 3) School, # MissedSchool, # DaysA 1 = None 2 = 1 to 3 days 3 = 4 to 6 days 4 = > 6 days Daycare, # MissedDaycare, # YesNoS UnableToPlay, # CaretakerWork, # MissedCaretakerWork, # ParentDaysOfPainExact, # ParentDaysOfPainRange, # DaysB 2 = 1 to 3 days 3 = 4 to 6 days 4 = > 6 days ParentPainScale, # ParentChildOverallPain, # PainScal 1 = Excellent 2 = Good 3 = Adequate 4 = Some 5 = None OneToTen 0 = 0 1 = 1 2 = 2 3 = 3 4 = 4 5 = 5 6 = 6 7 = 7 8 = 8 9 = 9 10 = 10 39

40 Phone (3 of 3) ChildDaysOfPainExact, # ChildDaysOfPainRange, # ChildPainScale, # OlderChildOverallPain, # PainScal 1 = Excellent 2 = Good 3 = Adequate 4 = Some 5 = None OneToTen 0 = 0 1 = 1 2 = 2 3 = 3 4 = 4 5 = 5 6 = 6 7 = 7 8 = 8 9 = 9 10 = 10 DaysB 2 = 1 to 3 days 3 = 4 to 6 days 4 = > 6 days 40

41 MAGiC Telephone Follow-up Ages 4-18: Phone_v3 (1 of 3) PhoneOccur, # YesNo YesNoS ParentInterview, # ChildInterview, # Rehosp7day, # YesNoS RehospDay, # Phone_PhoneRehos RehospTime, $5 RehospDischargeDay, # RehospLoc, # RehospSource, # Rehos 1 = Study Hospital 2 = Other Hospital Unsched7day, # YesNoS UnschedDay, # UnschedLocOther, $201 UnschedLoc, # UnschedSource, # Phone_PhoneUnsched UnCare 1 = ED/Emergent Care 2 = Primary Care Physician office 3 = Clinic 90 = Other (specify) Source 1 = Parent 2 = Chart 3 = Parent & Chart 41

42 Phone_v3 (2 of 3) School, # MissedSchool, # DaysA 1 = None 2 = 1 to 3 days 3 = 4 to 6 days 4 = > 6 days Daycare, # MissedDaycare, # YesNoS UnableToPlay, # CaretakerWork, # MissedCaretakerWork, # ParentDaysOfPainExact, # ParentDaysOfPainRange, # DaysB 1 = 0 2 = 1-3 days 3 = 4-6 days 4 = > 6 days ParentChildOverallPain_v2, # PainScalNew 1 = Much better 2 = A little better 3 = The same 4 = A little worse 5 = Much worse 6 = No pain since discharge ParentPainScale, # OneToTen 0 = 0 1 = 1 2 = 2 3 = 3 4 = 4 5 = 5 6 = 6 7 = 7 8 = 8 9 = 9 10 = 10 42

43 Phone_v3 (3 of 3) ChildDaysOfPainExact, # ChildDaysOfPainRange, # OlderChildOverallPain_v2, # ChildPainScale, # PainScalNew 1 = Much better 2 = A little better 3 = The same 4 = A little worse 5 = Much worse 6 = No pain since discharge OneToTen 0 = 0 1 = 1 2 = 2 3 = 3 4 = 4 5 = 5 6 = 6 7 = 7 8 = 8 9 = 9 10 = 10 DaysB 1 = 0 2 = 1-3 days 3 = 4-6 days 4 = > 6 days 43

44 MAGiC Telephone Follow-up Ages 19-21: PhoneAdult (1 of 2) PhoneOccur, # YesNo YesNoS PatientInterview, # Rehosp7day, # YesNoS YesNoS RehospDay, # PhoneAdult_PhoneRehos UnschedDay, # Unsched7day, # RehospTime, $5 UnschedLoc, # RehospDischargeDay, # UnschedLocOther, $13 RehospLoc, # Rehos 1 = Study Hospital 2 = Other Hospital UnschedSource, # RehospSource, # Sources 1 = Patient 2 = Chart 3 = Patient and Chart PhoneAdult_PhoneUnsched UnCare 1 = ED/Emergent Care 2 = Primary Care Physician office 3 = Clinic 90 = Other (specify) Sources 1 = Patient 2 = Chart 3 = Patient and Chart 44

45 PhoneAdult (2 of 2) YesNoS School, # MissedSchool, # DaysA 1 = None 2 = 1 to 3 days 3 = 4 to 6 days 4 = > 6 days YesNoS Work, # MissedWork, # DaysA 1 = None 2 = 1 to 3 days 3 = 4 to 6 days 4 = > 6 days DaysOfPainRange, # DaysOfPainExact, # OverallPain, # DaysB 1 = 0 days 2 = 1 to 3 days 3 = 4 to 6 days 4 = > 6 days PainScale, # PainScalNew 1 = Much better 2 = A little better 3 = The same 4 = A little worse 5 = Much worse 6 = No pain since discharge OneToTen 0 = 0 1 = 1 2 = 2 3 = 3 4 = 4 5 = 5 6 = 6 7 = 7 8 = 8 9 = 9 10 = 10 45

46 FollowUp (1 of 1) MAGiC Follow-Up Visit: YesNo FUOccur, # FUDay, # Rehosp8to28day, # YesNoS RehospDay, # RehospDischargeDay, # YesNoS FollowUp_Rehos RehospLoc, # RehospSource, # Unsched8to28day, # Rehos 1 = Study Hospital 2 = Other Hospital UnschedDay, # UnschedLoc, # UnschedLocOther, $19 UnschedSource, # FollowUp_Unsched UnCare 1 = ED/Emergent Care 2 = Primary Care Physician Office 3 = Clinic 4 = Other (specify) Source 1 = Parent 2 = Chart 3 = Parent & Chart FULabsDone, # YesNoS FULabDay, # FULabTime, $5 Hematocrit, # Hemoglobin, # WBC, # Platelets, # Reticulocytes, # LDH, # FollowUp_FULabs LostSTO, # LostPain, # LostCall t lost to follow-up 1 = Lost to follow-up W = Withdrew from follow-up I = Ineligible for study 46

47 BloodTransfusions (1 of 1) MAGiC Blood Transfusions Post Hospital Discharge: Biomarker, # YesNoC ; complete the next question ; no further data collection on this form is required Type 1 = Packed RBC 90 = Other (specify) 92 = Unknown BloodTrans, # BloodTransDay, # BloodTransTypeOth, $25 BloodTransType, # BloodTransSource, # BloodTransLoc, # YN ; complete the following information ; no further data collection on this form is required Source 1 = Parent 2 = Chart 3 = Parent & Chart Loc 1 = Study hospital 2 = Other hospital 47

48 Mortality (1 of 1) MAGiC Day 28 Patient Mortality: DayDetermined, # VitalStatus, # Status 1 = Alive 2 = Dead 93 = Unable to determine AliveStatusDay, # 48

49 Withdrawal (1 of 1) MAGiC Withdrawal of Consent: ElementsWithdrawn, # DayConsentWithdrawn, # TimeConsentWithdrawn, $5 ReasonConsentWithdrawn, $409 WOC 1 = Withdrew consent to continue on study medication; obtaining blood samples and data collection can continue 2 = Withdrew consent for study medication and obtaining of blood samples; data collection to continue 3 = Withdrew consent to obtain blood samples; study medication and data collection can continue 4 = Withdrew consent for study medication, blood samples, and data collection to continue, except AEs and follow up 5 = Withdrew consent for study medication, blood samples, data collection, and any contact or follow up 49

50 Biomarkers (1 of 1) Biomarkers: Variable Format Type Label Algorithm / Notes Draw_Code $50 Draw code sp_selectin # Plasma level of sp-selectin svcam_1 # Plasma level of svcam-1 Nitrite # Plasma nitrite IL_1b # Plasma level of IL-1\beta IL_6 # Plasma level of IL-6 TNFa # Plasma level of TNF-\alpha IFNg # Plasma level of IFN-\gamma = 0.01 if sp_selectinraw is.o = sp_selectinraw otherwise = 0.01 if svcam_1raw is.o = svcam_1raw otherwise = 0.01 if NitriteRaw is.o = NitriteRaw otherwise = 0.01 if IL_1bRaw is.o = IL_1bRaw otherwise = 0.01 if IL_6Raw is.o = IL_6Raw otherwise = 0.01 if TNFaRaw is.o = TNFaRaw otherwise = 0.01 if IFNgRaw is.o = IFNgRaw otherwise 50

51 PainScores (1 of 1) Pain Scores: Variable Format Type Label Algorithm / Notes FirstPainScore # First pain score LastPainScore # Last pain score FUPainYN # FU pain score available FUPainScore # FU pain score 51

52 QL Scores: QLScores (1 of 3) Visit 0 = Time 0 - Prior to 1st study drug infusion 1 = Time 1 - After last dose of study drug 2 = Time 2 - Telephone follow-up 3 = Time 3 - Follow-up visit Variable Format Type Label Algorithm / Notes Visit Visit # Please indicate at which visit this survey was completed c_painhurt # Child: Pain and Hurt Summary c_painimpact # Child: Pain Impact Summary c_worryi # Child: Worry Summary (I) c_worryii # Child: Worry Summary (II) c_emotions # Child: Emotions Summary c_painmanagement # c_treatment # c_communicationi # c_communicationii # Child: Pain Management Summary Child: Symptoms and Treatment Summary Child: Communication Summary (I) Child: Communication Summary (II) c_sicklecell # Child: PedsQL Sickle Cell c_general # Child: General Fatigue Summary c_sleep # Child: Sleep and Rest Fatigue Summary 52

53 QLScores (2 of 3) Variable Format Type Label Algorithm / Notes c_cognitive # Child: Cognitive Fatigue Summary c_fatigue # Child: PedsQL Fatigue c_physical # Child: Physical Functioning Summary c_emotional # Child: Emotional Functioning c_social # Child: Social Functioning c_school # Child: School Functioning c_psychosocial # Child: Psychosocial Score c_generic # Child: PedsQL Generic p_painhurt # Parent: Pain and Hurt Summary p_painimpact # Parent: Pain Impact Summary p_worryi # Parent: Worry Summary (I) p_worryii # Parent: Worry Summary (II) p_emotions # Parent: Emotions Summary p_painmanagement # p_treatment # Parent: Pain Management Summary Parent: Symptoms and Treatment Summary 53

54 QLScores (3 of 3) Variable Format Type Label Algorithm / Notes p_communicationi # Parent: Communication Summary p_communicationii # Parent: Communication Summary p_sicklecell # Parent: PedsQL Sickle Cell p_general # Parent: General Fatigue Summary p_sleep # p_cognitive # Parent: Sleep and Rest Fatigue Summary Parent: Cognitive Fatigue Summary p_fatigue # Parent: PedsQL Fatigue p_physical # Parent: Physical Functioning Summary p_emotional # Parent: Emotional Functioning p_social # Parent: Social Functioning p_school # Parent: School Functioning p_psychosocial # Parent: Psychosocial Score p_generic # Parent: PedsQL Generic Occurrence # Occurrence 54

55 PedsFamily (1 of 1) MAGIC Peds Quality of Life Family Information Form Ages 4-18: RelationChild, # RelationChildOther, $8 Relate 1 = Mother, Step Mother, Foster Mother 2 = Father, Step Father, Foster Father 3 = Grandmother 4 = Grandfather 5 = Guardian 90 = Other MomMaritalStatus, # MomEducation, # DadMaritalStatus, # DadEducation, # Marital 1 = Single 2 = Married 3 = Separated 4 = Living with someone 5 = Divorced 6 = Widowed HospitalVisits, # ChronicCondition, # YesNoS Educate 1 = 6th grade or less 2 = 7th - 9th grade 3 = 10th - 12th grade 4 = High school graduate 5 = Some college or certification course 6 = College graduate 7 = Graduate or Professional degree NumberHospitalVisits, # NumHospVisitsPain, # NumHospVisitsACS, # YesNoS EDVisits, # NumberEDVisits, # NumEDVisitsPain, # NumEDVisitsACS, # DaysMissSchool, # DaysSick, # DaysChildcare, # YesNoS ParentNotWork, # ParentMissWork, # ParentRoutine, # ParentConcentrate, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always 55

56 PedsAdult (1 of 1) MAGIC Peds Quality of Life Adult Patient Information Form Ages 19-21: MaritalStatus, # Education, # Marital 1 = Single 2 = Married 3 = Separated 4 = Living with someone 5 = Divorced 6 = Widowed ChronicCondition, # YesNoS Educate 1 = 6th grade or less 2 = 7th - 9th grade 3 = 10th - 12th grade 4 = High school graduate 5 = Some college or certification course 6 = College graduate 7 = Graduate or Professional degree YesNoS HospitalVisits, # EDVisits, # NumberHospitalVisits, # NumberEDVisits, # NumHospVisitsPain, # NumHospVisitsACS, # NumEDVisitsPain, # NumEDVisitsACS, # DaysMissSchoolWork, # DaysSick, # DaysCare, # Routine, # Concentrate, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always 56

57 PedsToddler (1 of 8) MAGIC PedsQL Parent Report for Toddlers (age 4): Visit, # VisitDay, # SurveyParent, # YesNoS Visit 0 = Time 0 - Prior to 1st study drug infusion 1 = Time 1 - After last dose of study drug 2 = Time 2 - Telephone follow-up 3 = Time 3 - Follow-up visit PRHurtALot, # PRHurtAllOver, # PRHurtArms, # PRHurtLegs, # PRHurtStomach, # PRHurtChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRHurtBack, # PRPainEveryday, # PRPainMedicine, # 57

58 PedsToddler (2 of 8) PRMightGetPain, # PRMissSchoolPain, # PRAlonePain, # PRRunPain, # PRFunPain, # PRMovePain, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRStandPain, # PRTakeCarePain, # PROtherMightGetPain, # PRUpAtNightPain, # PRTiredPain, # 58

59 PedsToddler (3 of 8) PRWorryPain, # PRPeopleWorryPain, # PRWorryAwayHome, # PRWorryEmergency, # PRWorryHospital, # PRWorryStroke, # PRWorryChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRScaredNeedles, # PRMadDisease, # PRMadPain, # 59

60 PedsToddler (4 of 8) PRHeadaches, # PRYellowEyes, # PRManagePain, # PRControlPain, # PRFeelsMedicine, # PRTastesMedicine, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRSleepyMedicine, # PRWorkingMedicine, # PRWorkingTreatments, # PRNotFeelBetterMedicine, # PRFeelsDifferent, # 60

61 PedsToddler (5 of 8) PRTellOtherPain, # PRTellDocsPain, # PRAskQuestions, # PRNotUnderstandDisease, # PRNotUnderstandPain, # PRTellOthersDisease, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRFeelTired, # PRFeelPhysicalWeak, # PRFeelTiredForLikes, # PRFeelTiredFriends, # PRTroubleFinish, # PRTroubleStart, # 61

62 PedsToddler (6 of 8) PRSleepALot, # PRDifficultSleep, # PRFeelTiredMorning, # PRRestALot, # PRTakingNaps, # PRTimeInBed, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRAttention, # PRRememberTold, # PRRememberHeard, # PRThinkQuick, # PRRememberThink, # PRRememberMoreOne, # 62

63 PedsToddler (7 of 8) PRWalking, # PRRunning, # PRPlayOrExercise, # PRLiftHeavy, # PRBathing, # PRPickUpToys, # PRHurtsOrAches, # PRLowEnergy, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRFeelAfraid, # PRFeelSad, # PRFeelAngry, # PRTroubleSleep, # PRWorrying, # 63

64 PedsToddler (8 of 8) PRPlayWithChild, # PRNoKidsWantToPlay, # PRGetTeased, # PRNotAble, # PRKeepingUpWithOthers, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRSameActivities, # PRMissSchoolNotWell, # PRMissSchoolDoctor, # 64

65 PedsYoungChild (1 of 16) MAGIC PedsQL Parent and Young Child Report (age 5-7): Visit, # Visit 0 = Time 0 - Prior to 1st study drug infusion 1 = Time 1 - After last dose of study drug 2 = Time 2 - Telephone follow-up 3 = Time 3 - Follow-up visit YesNoS SurveyChild, # SurveyParent, # VisitDayChild, # VisitDayParent, # HurtALot, # HurtAllOver, # HurtArms, # HurtLegs, # HurtStomach, # HurtChest, # YCScale t at all 4 = A lot HurtBack, # PainEveryday, # PainMedicine, # 65

66 PedsYoungChild (2 of 16) MightGetPain, # MissSchoolPain, # AlonePain, # RunPain, # FunPain, # MovePain, # YCScale t at all 4 = A lot StandPain, # TakeCarePain, # OtherMightGetPain, # UpAtNightPain, # TiredPain, # 66

67 PedsYoungChild (3 of 16) WorryPain, # PeopleWorryPain, # WorryAwayHome, # WorryEmergency, # WorryHospital, # YCScale t at all 4 = A lot ScaredNeedles, # MadDisease, # MadPain, # 67

68 PedsYoungChild (4 of 16) Headaches, # YellowEyes, # ManagePain, # ControlPain, # FeelsMedicine, # TastesMedicine, # YCScale t at all 4 = A lot SleepyMedicine, # WorkingMedicine, # WorkingTreatments, # NotFeelBetterMedicine, # FeelsDifferent, # 68

69 PedsYoungChild (5 of 16) TellOtherPain, # TellDocsPain, # AskQuestions, # NotUnderstandDisease, # NotUnderstandPain, # TellOthersDisease, # YCScale t at all 4 = A lot FeelTired, # FeelPhysicalWeak, # FeelTiredForLikes, # FeelTiredFriends, # TroubleFinish, # TroubleStart, # 69

70 PedsYoungChild (6 of 16) SleepALot, # DifficultSleep, # FeelTiredMorning, # RestALot, # TakingNaps, # TimeInBed, # YCScale t at all 4 = A lot Attention, # RememberTold, # RememberHeard, # ThinkQuick, # RememberThink, # RememberMoreOne, # 70

71 PedsYoungChild (7 of 16) Walking, # Running, # PlayOrExercise, # LiftHeavy, # Bathing, # PickUpToys, # HurtsOrAches, # HurtsOrAchesSpecify, $23 LowEnergy, # YCScale t at all 4 = A lot FeelAfraid, # FeelSad, # FeelAngry, # TroubleSleep, # Worrying, # 71

72 PedsYoungChild (8 of 16) PlayWithChild, # NoKidsWantToPlay, # GetTeased, # NotAble, # KeepingUpWithOthers, # YCScale t at all 4 = A lot PayAttention, # ForgetThings, # KeepUpWithSchool, # MissSchoolNotWell, # MissSchoolDoctor, # 72

73 PedsYoungChild (9 of 16) PRHurtALot, # PRHurtAllOver, # PRHurtArms, # PRHurtLegs, # PRHurtStomach, # PRHurtChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRHurtBack, # PRPainEveryday, # PRPainMedicine, # 73

74 PedsYoungChild (10 of 16) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRMightGetPain, # PRMissSchoolPain, # PRAlonePain, # PRRunPain, # PRFunPain, # PRMovePain, # PRStandPain, # PRTakeCarePain, # PROtherMightGetPain, # PRUpAtNightPain, # PRTiredPain, # 74

75 PedsYoungChild (11 of 16) PRWorryPain, # PRPeopleWorryPain, # PRWorryAwayHome, # PRWorryEmergency, # PRWorryHospital, # PRWorryStroke, # PRWorryChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRScaredNeedles, # PRMadDisease, # PRMadPain, # 75

76 PedsYoungChild (12 of 16) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRHeadaches, # PRYellowEyes, # PRManagePain, # PRControlPain, # PRFeelsMedicine, # PRTastesMedicine, # PRSleepyMedicine, # PRWorkingMedicine, # PRWorkingTreatments, # PRNotFeelBetterMedicine, # PRFeelsDifferent, # 76

77 PedsYoungChild (13 of 16) PRTellOtherPain, # PRTellDocsPain, # PRAskQuestions, # PRNotUnderstandDisease, # PRNotUnderstandPain, # PRTellOthersDisease, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRFeelTired, # PRFeelPhysicalWeak, # PRFeelTiredForLikes, # PRFeelTiredFriends, # PRTroubleFinish, # PRTroubleStart, # 77

78 PedsYoungChild (14 of 16) PRSleepALot, # PRDifficultSleep, # PRFeelTiredMorning, # PRRestALot, # PRTakingNaps, # PRTimeInBed, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRAttention, # PRRememberTold, # PRRememberHeard, # PRThinkQuick, # PRRememberThink, # PRRememberMoreOne, # 78

79 PedsYoungChild (15 of 16) PRWalking, # PRRunning, # PRPlayOrExercise, # PRLiftHeavy, # PRBathing, # PRPickUpToys, # PRHurtsOrAches, # PRLowEnergy, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRFeelAfraid, # PRFeelSad, # PRFeelAngry, # PRTroubleSleep, # PRWorrying, # 79

80 PedsYoungChild (16 of 16) PRPlayWithChild, # PRNoKidsWantToPlay, # PRGetTeased, # PRNotAble, # PRKeepingUpWithOthers, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRPayAttention, # PRForgetThings, # PRKeepUpWithSchool, # PRMissSchoolNotWell, # PRMissSchoolDoctor, # 80

81 PedsChildParentDates (1 of 1) MAGiC PedsQL Child and Parent QOL Survey Dates: YesNoS SurveyChild, # Visit, # SurveyParent, # Visit 0 = Time 0 - Prior to 1st study drug infusion 1 = Time 1 - After last dose of study drug 2 = Time 2 - Telephone follow-up 3 = Time 3 - Follow-up visit VisitDayChild, # VisitDayParent, # 81

82 PedsChild (1 of 16) MAGiC PedsQL Parent and Child Report (ages 8-12): Visit, # Visit 0 = Time 0 - Prior to 1st study drug infusion 1 = Time 1 - After last dose of study drug 2 = Time 2 - Telephone follow-up 3 = Time 3 - Follow-up visit YesNoS SurveyChild, # SurveyParent, # VisitDayChild, # VisitDayParent, # HurtALot, # HurtAllOver, # HurtArms, # HurtLegs, # HurtStomach, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always HurtChest, # HurtBack, # PainEveryday, # PainMedicine, # 82

83 PedsChild (2 of 16) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always MightGetPain, # MissSchoolPain, # AlonePain, # RunPain, # FunPain, # MovePain, # StandPain, # TakeCarePain, # OtherMightGetPain, # UpAtNightPain, # TiredPain, # 83

84 PedsChild (3 of 16) WorryPain, # PeopleWorryPain, # WorryAwayHome, # WorryEmergency, # WorryHospital, # WorryStroke, # WorryChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always ScaredNeedles, # MadDisease, # MadPain, # 84

85 PedsChild (4 of 16) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always Headaches, # YellowEyes, # ManagePain, # ControlPain, # TakeMedicine, # FeelsMedicine, # TastesMedicine, # SleepyMedicine, # WorkingMedicine, # WorkingTreatments, # NotFeelBetterMedicine, # FeelsDifferent, # 85

86 PedsChild (5 of 16) TellOtherPain, # TellDocsPain, # AskQuestions, # NotUnderstandDisease, # NotUnderstandPain, # TellOthersDisease, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always FeelTired, # FeelPhysicalWeak, # FeelTiredForLikes, # FeelTiredFriends, # TroubleFinish, # TroubleStart, # 86

87 PedsChild (6 of 16) SleepALot, # DifficultSleep, # FeelTiredMorning, # RestALot, # TakingNaps, # TimeInBed, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always Attention, # RememberTold, # RememberHeard, # ThinkQuick, # RememberThink, # RememberMoreOne, # 87

88 PedsChild (7 of 16) Walking, # Running, # PlayOrExercise, # LiftHeavy, # Bathing, # PickUpToys, # HurtsOrAches, # LowEnergy, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always FeelAfraid, # FeelSad, # FeelAngry, # TroubleSleep, # Worrying, # 88

89 PedsChild (8 of 16) PlayWithChild, # NoKidsWantToPlay, # GetTeased, # NotAble, # KeepingUpWithOthers, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PayAttention, # ForgetThings, # KeepUpWithSchool, # MissSchoolNotWell, # MissSchoolDoctor, # 89

90 PedsChild (9 of 16) PRHurtALot, # PRHurtAllOver, # PRHurtArms, # PRHurtLegs, # PRHurtStomach, # PRHurtChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRHurtBack, # PRPainEveryday, # PRPainMedicine, # 90

91 PedsChild (10 of 16) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRMightGetPain, # PRMissSchoolPain, # PRAlonePain, # PRRunPain, # PRFunPain, # PRMovePain, # PRStandPain, # PRTakeCarePain, # PROtherMightGetPain, # PRUpAtNightPain, # PRTiredPain, # 91

92 PedsChild (11 of 16) PRWorryPain, # PRPeopleWorryPain, # PRWorryAwayHome, # PRWorryEmergency, # PRWorryHospital, # PRWorryStroke, # PRWorryChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRScaredNeedles, # PRMadDisease, # PRMadPain, # 92

93 PedsChild (12 of 16) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRHeadaches, # PRYellowEyes, # PRManagePain, # PRControlPain, # PRTakeMedicine, # PRFeelsMedicine, # PRTastesMedicine, # PRSleepyMedicine, # PRWorkingMedicine, # PRWorkingTreatments, # PRNotFeelBetterMedicine, # PRFeelsDifferent, # 93

94 PedsChild (13 of 16) PRTellOtherPain, # PRTellDocsPain, # PRAskQuestions, # PRNotUnderstandDisease, # PRNotUnderstandPain, # PRTellOthersDisease, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRFeelTired, # PRFeelPhysicalWeak, # PRFeelTiredForLikes, # PRFeelTiredFriends, # PRTroubleFinish, # PRTroubleStart, # 94

95 PedsChild (14 of 16) PRSleepALot, # PRDifficultSleep, # PRFeelTiredMorning, # PRRestALot, # PRTakingNaps, # PRTimeInBed, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRAttention, # PRRememberTold, # PRRememberHeard, # PRThinkQuick, # PRRememberThink, # PRRememberMoreOne, # 95

96 PedsChild (15 of 16) PRWalking, # PRRunning, # PRPlayOrExercise, # PRLiftHeavy, # PRBathing, # PRPickUpToys, # PRHurtsOrAches, # PRLowEnergy, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRFeelAfraid, # PRFeelSad, # PRFeelAngry, # PRTroubleSleep, # PRWorrying, # 96

97 PedsChild (16 of 16) PRPlayWithChild, # PRNoKidsWantToPlay, # PRGetTeased, # PRNotAble, # PRKeepingUpWithOthers, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRPayAttention, # PRForgetThings, # PRKeepUpWithSchool, # PRMissSchoolNotWell, # PRMissSchoolDoctor, # 97

98 PedsTeen (1 of 16) MAGiC PedsQL Parent and Teen Report (ages 13-18): Visit, # Visit 0 = Time 0 - Prior to 1st study drug infusion 1 = Time 1 - After last dose of study drug 2 = Time 2 - Telephone follow-up 3 = Time 3 - Follow-up visit YesNoS SurveyChild, # SurveyParent, # VisitDayChild, # VisitDayParent, # HurtALot, # HurtAllOver, # HurtArms, # HurtLegs, # HurtStomach, # HurtChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always HurtBack, # PainEveryday, # PainMedicine, # 98

99 PedsTeen (2 of 16) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always MightGetPain, # MissSchoolPain, # AlonePain, # RunPain, # FunPain, # MovePain, # StandPain, # TakeCarePain, # OtherMightGetPain, # UpAtNightPain, # TiredPain, # 99

100 PedsTeen (3 of 16) WorryPain, # PeopleWorryPain, # WorryAwayHome, # WorryEmergency, # WorryHospital, # WorryStroke, # WorryChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always ScaredNeedles, # MadDisease, # MadPain, # 100

101 PedsTeen (4 of 16) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always Headaches, # YellowEyes, # ManagePain, # ControlPain, # TakeMedicine, # FeelsMedicine, # TastesMedicine, # SleepyMedicine, # WorkingMedicine, # WorkingTreatments, # NotFeelBetterMedicine, # FeelsDifferent, # 101

102 PedsTeen (5 of 16) TellOtherPain, # TellDocsPain, # AskQuestions, # NotUnderstandDisease, # NotUnderstandPain, # TellOthersDisease, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always FeelTired, # FeelPhysicalWeak, # FeelTiredForLikes, # FeelTiredFriends, # TroubleFinish, # TroubleStart, # 102

103 PedsTeen (6 of 16) SleepALot, # DifficultSleep, # FeelTiredMorning, # RestALot, # TakingNaps, # TimeInBed, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always Attention, # RememberTold, # RememberHeard, # ThinkQuick, # RememberThink, # RememberMoreOne, # 103

104 PedsTeen (7 of 16) Walking, # Running, # PlayOrExercise, # LiftHeavy, # Bathing, # PickUpToys, # HurtsOrAches, # LowEnergy, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always FeelAfraid, # FeelSad, # FeelAngry, # TroubleSleep, # Worrying, # 104

105 PedsTeen (8 of 16) PlayWithChild, # NoKidsWantToPlay, # GetTeased, # NotAble, # KeepingUpWithOthers, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PayAttention, # ForgetThings, # KeepUpWithSchool, # MissSchoolNotWell, # MissSchoolDoctor, # 105

106 PedsTeen (9 of 16) PRHurtALot, # PRHurtAllOver, # PRHurtArms, # PRHurtLegs, # PRHurtStomach, # PRHurtChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRHurtBack, # PRPainEveryday, # PRPainMedicine, # 106

107 PedsTeen (10 of 16) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRMightGetPain, # PRMissSchoolPain, # PRAlonePain, # PRRunPain, # PRFunPain, # PRMovePain, # PRStandPain, # PRTakeCarePain, # PROtherMightGetPain, # PRUpAtNightPain, # PRTiredPain, # 107

108 PedsTeen (11 of 16) PRWorryPain, # PRPeopleWorryPain, # PRWorryAwayHome, # PRWorryEmergency, # PRWorryHospital, # PRWorryStroke, # PRWorryChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRScaredNeedles, # PRMadDisease, # PRMadPain, # 108

109 PedsTeen (12 of 16) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRHeadaches, # PRYellowEyes, # PRManagePain, # PRControlPain, # PRTakeMedicine, # PRFeelsMedicine, # PRTastesMedicine, # PRSleepyMedicine, # PRWorkingMedicine, # PRWorkingTreatments, # PRNotFeelBetterMedicine, # PRFeelsDifferent, # 109

110 PedsTeen (13 of 16) PRTellOtherPain, # PRTellDocsPain, # PRAskQuestions, # PRNotUnderstandDisease, # PRNotUnderstandPain, # PRTellOthersDisease, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRFeelTired, # PRFeelPhysicalWeak, # PRFeelTiredForLikes, # PRFeelTiredFriends, # PRTroubleFinish, # PRTroubleStart, # 110

111 PedsTeen (14 of 16) PRSleepALot, # PRDifficultSleep, # PRFeelTiredMorning, # PRRestALot, # PRTakingNaps, # PRTimeInBed, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRAttention, # PRRememberTold, # PRRememberHeard, # PRThinkQuick, # PRRememberThink, # PRRememberMoreOne, # 111

112 PedsTeen (15 of 16) PRWalking, # PRRunning, # PRPlayOrExercise, # PRLiftHeavy, # PRBathing, # PRPickUpToys, # PRHurtsOrAches, # PRLowEnergy, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRFeelAfraid, # PRFeelSad, # PRFeelAngry, # PRTroubleSleep, # PRWorrying, # 112

113 PedsTeen (16 of 16) PRPlayWithChild, # PRNoKidsWantToPlay, # PRGetTeased, # PRNotAble, # PRKeepingUpWithOthers, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PRPayAttention, # PRForgetThings, # PRKeepUpWithSchool, # PRMissSchoolNotWell, # PRMissSchoolDoctor, # 113

114 PedsYoungAdult (1 of 8) MAGiC PedsQL Young Adult Report (ages 19-21): Visit, # Visit 0 = Time 0 - Prior to 1st study drug infusion 1 = Time 1 - After last dose of study drug 2 = Time 2 - Telephone follow-up 3 = Time 3 - Follow-up visit VisitDay, # SurveyPatient, # YesNoS HurtALot, # HurtAllOver, # HurtArms, # HurtLegs, # HurtStomach, # HurtChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always HurtBack, # PainEveryday, # PainMedicine, # 114

115 PedsYoungAdult (2 of 8) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always MightGetPain, # MissSchoolPain, # AlonePain, # RunPain, # FunPain, # MovePain, # StandPain, # TakeCarePain, # OtherMightGetPain, # UpAtNightPain, # TiredPain, # 115

116 PedsYoungAdult (3 of 8) WorryPain, # PeopleWorryPain, # WorryAwayHome, # WorryEmergency, # WorryHospital, # WorryStroke, # WorryChest, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always ScaredNeedles, # MadDisease, # MadPain, # 116

117 PedsYoungAdult (4 of 8) QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always Headaches, # YellowEyes, # ManagePain, # ControlPain, # TakeMedicine, # FeelsMedicine, # TastesMedicine, # SleepyMedicine, # WorkingMedicine, # WorkingTreatments, # NotFeelBetterMedicine, # FeelsDifferent, # 117

118 PedsYoungAdult (5 of 8) TellOtherPain, # TellDocsPain, # AskQuestions, # NotUnderstandDisease, # NotUnderstandPain, # TellOthersDisease, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always FeelTired, # FeelPhysicalWeak, # FeelTiredForLikes, # FeelTiredFriends, # TroubleFinish, # TroubleStart, # 118

119 PedsYoungAdult (6 of 8) SleepALot, # DifficultSleep, # FeelTiredMorning, # RestALot, # TakingNaps, # TimeInBed, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always Attention, # RememberTold, # RememberHeard, # ThinkQuick, # RememberThink, # RememberMoreOne, # 119

120 PedsYoungAdult (7 of 8) Walking, # Running, # PlayOrExercise, # LiftHeavy, # Bathing, # PickUpToys, # HurtsOrAches, # LowEnergy, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always FeelAfraid, # FeelSad, # FeelAngry, # TroubleSleep, # Worrying, # 120

121 PedsYoungAdult (8 of 8) PlayWithChild, # NoKidsWantToPlay, # GetTeased, # NotAble, # KeepingUpWithOthers, # QLScale 0 = Never 1 = Almost never 3 = Often 4 = Almost always PayAttention, # ForgetThings, # KeepUpWithSchool, # MissSchoolNotWell, # MissSchoolDoctor, # 121