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Study Detail

Study ID 1002
Name Treatment of Pulmonary Hypertension and Sickle Cell Disease With Sildenafil Therapy
Contact Email biolincc@imsweb.com
Acronym walk-PHaSST
Period 2007 – 2009
Design Clinical Trial
Study PI Mark T. Gladwin
Institution Multiple institutes
URL https://biolincc.nhlbi.nih.gov/studies/walk_phasst/
CTGovID https://clinicaltrials.gov/ct2/show/NCT00492531
Funding Agency NHLBI
Grant Number HHSN268200617182C
Overview The Walk-PHaSST study explored whether sildenafil, a medication used to lessen symptoms of pulmonary hypertension, is also effective and safe for those with sickle cell disease who develop pulmonary hypertension.
Focus Areas 1. 6-Minute Walk
2. Sickle Cell Anemia
3. Sildenafil/Viagra
4. Tricuspid Regurgitant Velocity
5. Sickle Cell Disease
6. Pulmonary Hypertension
Outcomes 1. Change in Exercise Capacity as Assessed by 6 Minute Walk. [ Time Frame: Baseline to week 16/Imputed last visit. ]
2. Change From Baseline in Pulmonary Hypertension at Week 16 as Assessed by Tricuspid Regurgitant Jet Velocity [ Time Frame: 16 weeks ]
3. Borg Dyspnea Score [ Time Frame: baseline to 16 weeks ]
4. Brain Natriuretic Peptide(BNP)Levels. [ Time Frame: 16 weeks ]
Data Location BioLINCC, BioData Catalyst
Biospecimen Available N/A
Data Consent Data sharing via BioLINCC; Consent restricts use of data to research related to sickle cell disease.
Biospecimen Consent NA
Contact Consent NA
Genomic Data No
Age Range 12-70
No. Participants 720
Inclusion Criteria 1. Screening- Males or females, greater than or equal to 12 years of age and less than or equal to 70 years of age.
2. Screening - Diagnosis of sickle cell disease (including, but not limited to SS, SC, SD, or S-beta zero thalassemia).
3. Screening - Provision of informed consent and, where applicable, assent.
4. Participants with mild to severe pulmonary hypertension, defined as Doppler echocardiography peak tricuspid regurgitation velocity (TRV) of = 2.7 m/s, and a six minute walk distance of 150-500 meters, were further eligible for the interventional trial.
Exclusion Criteria 1. Current pregnancy or lactation.
2. Any one of the following medical conditions:Stroke within the last six weeks.Diagnosis of pulmonary embolism within the last three months.History of retinal detachment or retinal hemorrhage in the last 6 months.Non-arteritic anterior ischemic optic neuropathy (NAION) in one or both eyes.History of sustained priapism requiring medical or surgical treatment, unless currently impotent or on transfusion program within the last two years.Any unstable (chronic or acute) condition that in the opinion of the investigator will prevent completion of the study.
3. Subjects taking nitrate-based vasodilators (including, but not limited to nicorandil [available in the UK only]), prostacyclin (inhaled, subcutaneous or intravenous) or endothelin antagonists. Subjects taking calcium channel blockers will be allowed to participate if they are on a stable dose for greater than or equal to 3 months.
4. Left ventricular ejection fraction (LVEF) less than 40 percent or clinically significant ischemic, valvular or constrictive heart disease: LVEF less than 40 percent or SF less than 22 percent.
5. Subjects in other research studies with investigational drugs (with the exception of hydroxyurea) unless the other trial has been approved by the walk-PHaSST Executive Committee for co-participation.
6. Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (in particular with 6MWT), e.g., angina pectoris, intermittent claudication, symptomatic hip osteonecrosis.
7. Tonsillectomies for sleep apnea within 3 months prior to randomization. Active therapy for pulmonary hypertension, including prostacyclin analog, endothelin-1 antagonist, or PDE-5 inhibitor.
8. Protease inhibitor therapy for HIV treatment Subjects taking potent CYP3A4 inhibitor therapy (e.g., itraconazole, ritonavir, ketoconazole) Subjects who are anticoagulated and have proliferative retinopathy (unless they have had ophthalmologist recommended intervention (e.g., phototherapy) or have been cleared by the ophthalmologist to participate in the study.
9. Subjects with systolic blood pressure greater than or equal to 140 mmHg OR diastolic blood pressure greater than or equal to 90 mmHg.
Data ElementVariables
Substance Use ALC
ALCNUM
AM
COC
DRGOTH
DRUG
HEMAR
HER
SMK
SMKPKS
SMKPKS
SMKYST
Data ElementVariables
Acute Anemic Episode
Aplastic Crisis B_APL
Bleeding
Other Blood Problem B_ANEM
B_HEMO
B_OTH
B_UNSU
BLOOD
Sickle Cell Disease SCD_DIAG
SCD_TYPE
SCGENO
SCGENSP
Data ElementVariables
Cancer O_CAN
O_CANSP
Data ElementVariables
Aneurysm N_ANE
Cardiac Failure H_FAIL
Cardiovascular Problem
Heart Problem EV_RHF
H_ARH
H_ATK
H_CMY
H_ENL
H_HVP
H_OTH
H_OTSP
H_UNSU
HEART
S2_AHS
S2_EVP
Data ElementVariables
Gastrointestinal Problem L_CHCY
L_CHLS
L_GALL
Hepatitis
Liver Problem L_CIRR
L_FAIL
L_FIB
L_HEPA
L_HEPB
L_HEPC
L_HEPU
L_IC
L_OTH
L_OTSP
L_SEQ
L_TH
L_UNSU
LIVER
Data ElementVariables
Diabetes Mellitus O_DIAB
Endocrine Problem
Data ElementVariables
Family MedHx FALIVE
FCAUSE
MALIVE
MCAUSE
MDIS
MDIS
Data ElementVariables
Genitourinary Problem K_ED
K_HEM
K_OTSP
K_PROT
K_PYL
K_UNSU
KIDNEY
Kidney Problem K_ARF
K_CR
K_CRF
Priapism K_PRI
PRIA
PRIAEX
PRIANUM
Renal Dialysis History RRT
RRT_SP
Data ElementVariables
Fever
HIV Infection PIT
RESULT
Immune Problem O_SLE
Infection I_BACT
I_OTH
I_SEPO
I_SEPP
I_UNSU
INFECT
Vaccination
Data ElementVariables
Sarcoidosis
Spleen Problem L_PAN
S_HYPER
S_INF
S_OTH
S_SEQ
S_SPMG
S_UNSU
SPLEEN
Data ElementVariables
Adverse event AETEXT
EV_NO
NARRATE
NARRPR
NARRSP
OUTCOME
RELSCD
RELSP
S1_ABDO
S1_CHST
S1_FNT
S1_OTH
S1_SP
S1_SPTM
S2_ENLV
S2_OTH
S2_SP
S2_SWFA
SERIOUS
SEVRTY
SP_SP
STARTDA
STARTMO
STARTYR
Death AUTOP
CAUSE
DEATHDA
DEATHMO
DEATHYR
Disability Status
Hospitalization
Medical Event
Serious Adverse Event COND
FACT1
FACT2
FACT3
FACT3SP
FACT4
FACT5
FACT5SP
FACT6
FACT6SP
HISTNA
HISTPR
HISTSP
HONGO
HSTPDA
HSTPMO
HSTPYR
HSTRTDA
HSTRTMO
HSTRTYR
LDATEDA
LDATEMO
LDATEYR
RANGE
RESULT
SAE1
SAE2
SAE3
SAE4J
SAEE
SAES
Data ElementVariables
Medical History O_AMOF
O_OTH
O_OTSP
O_UNSU
OTHDIS
Data ElementVariables
Anxiety
Depression N_DEP
Emotional Health SFQ5A
SFQ5B
SFQ5C
SFQ9A
SFQ9B
SFQ9C
SFQ9D
SFQ9E
SFQ9F
SFQ9G
SFQ9H
SFQ9I
Mental status
Psychiatric Disorder
Data ElementVariables
Musculoskeletal Problem M_HIP
M_OSP
M_OTH
M_OTSP
M_SHL
M_ULC
M_UNSU
MBJ
Osteomyelitis M_OMY
Osteonecrosis M_AVH
M_AVH
Rheumatic Diseases O_RA
Data ElementVariables
Behavior
Cognition N_MEM
NEUR1
NEURCM
Developmental
Motor NEUR2
NEUR3
NEUR4
Sensation
Data ElementVariables
Meningitis I_MEN
Neurologic Event N_NPTHY
N_OTH
N_UNSU
NEURO
Seizure N_SZR
Stroke N_SCI
N_STR
N_STRH
NEUR5
STROKE
Transient Ischemic Attack N_TIA
Data ElementVariables
Nutritional and Metabolic O_IRON
O_VITD
Data ElementVariables
Ocular Problem VISDES
VISION
Sickle Retinopathy O_RET
Data ElementVariables
Abdominal Pain
General Pain AC_LOC1
AC_LOC2
AC_LOC3
AC_LOC4
AC_LOC5
AC_LOC6
AC_LOC7
AC_LOCO
AC_LOCS
AC_QUAL
AC_RATE
AC_TR1
AC_TR2
AC_TR3
AC_TR4
AC_TR5
AC_TR6
AC_TR6
AC_TRS
ANLG
ANLGAE
CH_LOC1
CH_LOC2
CH_LOC3
CH_LOC4
CH_LOC5
CH_LOC6
CH_LOC7
CH_LOCO
CH_LOCS
CH_QUAL
CH_RATE
CH_TR1
CH_TR2
CH_TR3
CH_TR4
CH_TR5
CH_TR6
CH_TRO
CH_TRS
CHRON
FOOTL
FOOTM
FOOTR
IQ2LLEGM
Q1
Q2ABDOC
Q2ABDOL
Q2ABDOM
Q2ABDOR
Q2BUTTL
Q2BUTTM
Q2BUTTR
Q2CHSTC
Q2CHSTL
Q2CHSTM
Q2CHSTR
Q2ELBL
Q2ELBM
Q2ELBR
Q2GEN
Q2GENM
Q2HANDL
Q2HANDM
Q2HANDR
Q2HEADC
Q2HEADL
Q2HEADM
Q2HEADR
Q2KNEEL
Q2KNEEM
Q2KNEER
Q2LARML
Q2LARMM
Q2LARMR
Q2LBCKC
Q2LBCKL
Q2LBCKM
Q2LBCKR
Q2LLEGL
Q2LLEGR
Q2NECK
Q2NECKM
Q2SHLDL
Q2SHLDM
Q2SHLDR
Q2UARML
Q2UARMM
Q2UARMR
Q2UBCKC
Q2UBCKL
Q2UBCKM
Q2UBCKR
Q2ULEGL
Q2ULEGM
Q2ULEGR
Q3
Q4
Q5
Q6
Q7
Q8
Q9A
Q9B
Q9C
Q9D
Q9E
Q9F
Q9G
SFQ7
SFQ8
Headache HEAD
HEADEX
HEADNUM
N_HDC
N_HDM
Management EVT2
EVT6
NUMSCP
PAIN
PAINEX
Pain Attack PNC_MEX
PNC_MMI
PNC_MMO
PNC_MSE
PNC_WEX
PNC_WMI
PNC_WMO
PNC_WSE
PNC_YEX
PNC_YMI
PNC_YMO
PNC_YSE
Skeletal and Joint Pain M_DAC
Data ElementVariables
Birth Outcome
Gestational Age
Menstruation AGEMEN1
AGEMEN2
CYCLE
LMPMO
LMPYR
NOTAPP
ONSET
REGULAR
STATUS
Pregnancy BIRTHS
PREG
Reproductive Behavior
Data ElementVariables
Acute Chest Syndrome ADJ_NAR
EV_ACS
EVT1
Asthma P_ASTH
Lung Disease CLASS
EV_PH
H_HYP
LUNG
P_CLD
P_PE
P_PH
PHDA
PHMO
PHNA
PHYR
RELPH
Other Respiratory Problem BRGPOST
P_COPD
P_CRPD
P_OTH
P_PNEU
P_UNSU
S1_CGH
S1_SHBR
S2_ALS
S2_CGH
S2_ICR
S2_TCHY
Data ElementVariables
Sleep Problem P_OSA
Data ElementVariables
Cardiovascular
Digestive CHL
CHL_C
CHL_YR
Genitourinary PEN
PEN_C
PEN_YR
Lymphatic SPL
SPL_C
SPL_YR
Musculoskeletal HCP
HCP_C
HCP_YR
HR
HR_C
HR_YR
Ocular LPE
LPE_C
LPE_YR
VIT
VIT_C
VIT_YR
Respiratory TON
TON_C
TON_YR
Surgery History IPL
IPL_C
IPL_YR
PROC
PROC_C
PROC_YR
RPL
RPL_C
RPL_YR
SUR_OTH
Data ElementVariables
Address
Age
Ethnic Group ETHNIC
Gender GENDER
Language
National Origin COUNTRY
CYUNK
SWHERE
Nuclear Family CAUSE
FULLSIB
FULLUNK
HALFSIB
HALFUNK
LIVING
RELATE
SCD
SCT
Race OTH_SP
RACE1
RACE2
RACE2A
RACE2B
RACE2C
RACE2D
RACE2E
RACE2F
RACE3
RACE4
RACE5
RACE6
RACE7
RACE8
Data ElementVariables
Facility Type LOC
Provider Type
Quality of Care
Visit EVENT
EVT10
EVT10SP
EVT11
EVT3
EVT4
EVT5
EVT7
EVT8
EVT9
EVTOT
EVTOTSP
Data ElementVariables
Country of Care CAREYRS
OUTCARE
Facility Type
Quality of Care
Data ElementVariables
Echocardiogram DGTS-TYPE4
S3_ECH
S3_ECHR
AR
DIABP
DRUGDA
DRUGHH
DRUGMM
DRUGMO
DRUGYR
ERAP
LVEF
LVFUN
MR
NODRUG
OTHSIG
SYSBP
TR
TRJV
TRJVND
Data ElementVariables
Electrocardiogram (ECG) DGTS-TYPE6
S3_ECG
S3_ECGR
Data ElementVariables
General Imaging DIAGTST
Data ElementVariables
Brain DGTS-TYPE1
DGTS-TYPE2
Heart
Hip
Liver
Data ElementVariables
Brain N_TCD
DGTS-TYPE3
Data ElementVariables
Abdomen
Biliary Tract
Chest S3_XCE
S3_XCON
S3_XDA
S3_XFIND
S3_XINF
S3_XMO
S3_XPE
S3_XRAY
S3_XYR
ABN1
ABN10
ABN1LIL
ABN1LSL
ABN1RIL
ABN1RML
ABN1RSL
ABN2
ABN3
ABN4
ABN5
ABN5LIL
ABN5LSL
ABN5RIL
ABN5RML
ABN5RSL
ABN6
ABN6LIL
ABN6LSL
ABN6RIL
ABN6RML
ABN6RSL
ABN7
ABN7LIL
ABN7LSL
ABN7RIL
ABN7RML
ABN7RSL
ABN8
ABN9
CODE
NOCODE
OTH_SP
RESULT
Extremities
Gallbladder
Liver
Skull
Data ElementVariables
Demographics FETHNIC
FOTH_SP
FRACE1
FRACE2
FRACE2A
FRACE2C
FRACE2D
FRACE2E
FRACE2F
FRACE3
FRACE4
FRACE5
FRACE6
FRACE7
FRACE8
FRACEZB
FWHERE
METHNIC
MOTH_SP
MRACE1
MRACE2
MRACE2A
MRACE2B
MRACE2D
MRACE2E
MRACE2F
MRACE3
MRACE4
MRACE5
MRACE6
MRACE7
MRACE8
MWHERE
Socioeconomic Status
Data ElementVariables
Cognitive Functioning
Emotional Functioning EMOFC1
EMOFC1
EMOFC2
EMOFC2
EMOFC3
EMOFC3
EMOFC4
EMOFC4
EMOFC5
EMOFC5
EMOFP1
EMOFP1
EMOFP2
EMOFP2
EMOFP3
EMOFP3
EMOFP4
EMOFP4
EMOFP5
EMOFP5
SFQ4B
Physical Functioning PHYFC1
PHYFC1
PHYFC2
PHYFC2
PHYFC3
PHYFC3
PHYFC4
PHYFC4
PHYFC5
PHYFC5
PHYFC6
PHYFC6
PHYFC7
PHYFC7
PHYFC8
PHYFC8
PHYFP1
PHYFP1
PHYFP2
PHYFP2
PHYFP3
PHYFP3
PHYFP4
PHYFP4
PHYFP5
PHYFP5
PHYFP6
PHYFP6
PHYFP7
PHYFP7
PHYFP8
PHYFP8
SFQ1
SFQ11A
SFQ11B
SFQ11C
SFQ11D
SFQ2
SFQ3A
SFQ3B
SFQ3C
SFQ3D
SFQ3E
SFQ3F
SFQ3G
SFQ3H
SFQ3I
SFQ3J
School Functioning SCHFC1
SCHFC1
SCHFC2
SCHFC2
SCHFC3
SCHFC3
SCHFC4
SCHFC4
SCHFC5
SCHFC5
SCHFP1
SCHFP1
SCHFP2
SCHFP2
SCHFP3
SCHFP3
SCHFP4
SCHFP4
SCHFP5
SCHFP5
Social Functioning SFQ10
SFQ4A
SFQ4C
SFQ4D
SFQ6
SOCFC1
SOCFC1
SOCFC2
SOCFC2
SOCFC3
SOCFC3
SOCFC4
SOCFC4
SOCFC5
SOCFC5
SOCFP1
SOCFP1
SOCFP2
SOCFP2
SOCFP3
SOCFP3
SOCFP4
SOCFP4
SOCFP5
SOCFP5
Data ElementVariables
Blood Differential Test
Blood Gases AOPOST
AOPRE
FRPOST
FRPRE
OSPOST
OSPRE
S3_ABG
S3_BNP
S3_CA02
S3_PA02
S3_PDEC
S3_SA02
S3_SP02
Blood Smear
Blood Typing
Coagulation Test APPT
APPTSG
INR
INRSG
Complete Blood Count B_LPT
B_LWBC
ANC
ANCSG
ANCUNIT
ARC
ARCSG
ARCUNIT
HCT
HCTSG
HCTUNIT
HGB
HGBSG
HGBUNIT
MCHC
MCHCSG
MCHUNIT
MCV
MCVSG
MCVUNIT
NEUT
NEUTSG
NEUTUNIT
PLAT
PLATSG
PLATUNIT
RBC
RBCSG
RBCUNIT
RET
RETSG
RETUNIT
WBC
WBCSG
WBCUNIT
Comprehensive Metabolic Panel (CMP) ALB
ALBSG
ALBUNIT
ALK
ALKSG
ALKUNIT
ALT
ALTSG
ALTUNIT
AST
ASTSG
ASTUNIT
BUN
BUNSG
BUNUNIT
CAL
CALSG
CALUNIT
CHL
CHLSG
CHLUNIT
CO2
CO2SG
CO2UNIT
CRE
CRESG
CRUNIT
MAG
MAGSG
MAGUNIT
PHOS
PHOSSG
POT
POTSG
POTUNIT
PUNIT
S3_AST
SOD
SODSG
SODUNIT
TBIL
TBILSG
TBUNIT
TPROT
TPROTSG
TPUNIT
Enzyme LDH
LDHSG
LDHUNIT
S3_CE
S3_CPH
S3_CTP
S3_LCD
S3_MYG
General BIOPDA
BIOPMO
BIOPYR
Hemoglobin Electrophoresis HEMA
HEMA2
HEMC
HEMF
HEMOSP
HEMOTH
HEMS
HIST
Iron
Data ElementVariables
Cardiovascular Test ASMT1HH
ASMT1MM
ASMT1TM
ASMT2HH
ASMT2MM
ASMT2TM
ASMT3HH
ASMT3MM
ASMT3TM
ASMT4HH
ASMT4MM
ASMT4TM
ASMT5HH
ASMT5MM
ASMT5TM
CODE
DEVICE
DIST
DPAP1
DPAP2
DPAP3
DPAP4
DPAP5
DRGHH
DRGMM
DRGTM
DSBP1
DSBP2
DSBP3
DSBP4
DSBP5
FRWALK
HRATE1
HRATE2
HRATE3
HRATE4
HRATE5
INOHH
INOMM
INOTM
LDSDDA
LDSDHH
LDSDMM
LDSDMO
LDSDYR
LVEDP1
LVEDP2
LVEDP3
LVEDP4
LVEDP5
METHOD
MPAP1
MPAP2
MPAP3
MPAP4
MPAP5
MPCWP1
MPCWP2
MPCWP3
MPCWP4
MPCWP5
MRAP1
MRAP2
MRAP3
MRAP4
MRAP5
MSP1
MSP2
MSP3
MSP4
MSP5
NOTSENT
OUTPUT1
OUTPUT2
OUTPUT3
OUTPUT4
OUTPUT5
SAS1
SAS2
SAS3
SAS4
SAS5
SIDE
SPAP1
SPAP2
SPAP3
SPAP4
SPAP5
SSBP1
SSBP2
SSBP3
SSBP4
SSBP5
STARTHH
STARTMM
SUBSTOP
SVOX1
SVOX2
SVOX3
SVOX4
SVOX5
TRJET
USE02
VISIT
Data ElementVariables
Genitourinary Test
Urine Test ACDA
ACMO
ACYR
ALB
BLD
BLDCODE
BLDVAL
COLLDA
COLLMO
COLLYR
CREAT
GLU
GLUCODE
GLUVAL
MENSES
MICROYN
NEWAE
OMICDES
OMICYN
OVERALL
PH
PRO
PROCODE
PROVAL
RATIO
RBC
SPGRAV
WBC
Data ElementVariables
Abdomen GASTCM
GASTNR
GASTOT
HEP
SPL
Anthropometrics APPWT
HEIGHT
HEIGHT
HTUNITS
S2_WTG
S3_WT
WEIGHT
WEIGHT
WTUNITS
Cardiovascular AIRO2
CARCM
CARDES
CARJD
CARM
CARM
CAROTH
CARP2
CARR
CARRD
CARS12
CARS3
CARS4
DIABP
O2
O2FLOW
SYSBP
HRATE
Extremities SKINHP
EXTCM
EXTED
EXTLUL
EXTLULD
EXTNC
EXTNH
EXTNN
EXTPL
EXTPLD
EXTSL
EXTSLD
General APP
APPCM
HEENTCM
HEENTHP
HEENTSI
HEENTTH
Liver
Reproductive
Respiratory PULBC
PULBW
PULCL
PULCM
RESP
Spleen
Vital signs BSA
DIAPOST
DIAPRE
HRPOST
HRPRE
S2_RHR
S3_RESP
S3_TEMP
SYSPOST
SYSPRE
TEMP
Data ElementVariables
Pregnancy TYPE
REASON
RESULT
OTH_SP
HCG
HCGSYM
Data ElementVariables
Pulmonary Function Test DGTS-TYPE5
A_25
A_25P
A_DIV
A_DIVP
B_25
B_25P
B_DIV
B_DIVP
B_FEV1
B_FEV1P
B_FVC
B_FVCP
D_VA
D_VAP
DC_VAC
DC_VACP
DLCO
DLCOC
DLCOCP
DLCOP
ERV
ERVP
FEV1
FEV1P
FRC
FRCP
FVC
FVCP
IC
ICP
RDIV
RDIVP
RV
RVP
TLC
TLCP
VA
VAP
Respiratory Test
Data ElementVariables
Antibiotics PEN
Asthma
Blood Medication History ACG
ERY
ERYC
FOL
IRON
IRONC
IRONSP
IRONTYP
Cardiovascular ACE
BETA
CCB
DIUR
ERA
PCY
PDE
PHT_OTH
PHT_SP
VASO
Compliance
Current Medication
Depression Medication History ADP
ADPSP
Hydroxyurea HYD
HYDC
Medication ALT
ALT_SP
DOSE
FREQ
FREQ_SP
IND
INHAL
MEDNAME
MEDS
NAME
REAC1
REAC2
REAC3
REAC4
REAC5
REACOTH
REACSP
RELSDRG
ROUTE
RTE_SP
S3_MD
S3_MDIM
S3_MDSP
S3_MDWL
S3_TH
SAE
STARTDA
STARTMO
STARTYR
STOPDA
STOPMO
STOPYR
TDOSE
TONGO
TREAT
TREATNA
TREATPR
TREATSP
TSTPDA
TSTPMO
TSTPYR
TSTRTDA
TSTRTMO
TSTRTYR
TUNITS
UNIT_SP
UNITS
STATUS
Neurologic Medication History ACV
ACVSP
Pain TYL3
VIC
PERC
OPM
OPMSP
OXCD
OXCT
COD
DEM
DIL
METH
MOR
NSAID
NSAIDC
NSAIDSP
SCD Medication BIOP
BIOPRS
OASA
OASASP
Sildenafil BOTNUM
D1_AMHH
D1_AMMM
D1_AMNT
D1_AMPT
D1_DA
D1_MDHH
D1_MDMM
D1_MDNT
D1_MDPT
D1_MO
D1_PMHH
D1_PMMM
D1_PMNT
D1_PMPT
D1_YR
D2_AMHH
D2_AMMM
D2_AMNT
D2_AMPT
D2_DA
D2_MDHH
D2_MDMM
D2_MDNT
D2_MDPT
D2_MO
D2_PMHH
D2_PMMM
D2_PMNT
D2_PMPT
D2_YR
D3_AMHH
D3_AMMM
D3_AMNT
D3_AMPT
D3_DA
D3_MDHH
D3_MDMM
D3_MDNT
D3_MDPT
D3_MO
D3_PMHH
D3_PMMM
D3_PMNT
D3_PMPT
D3_YR
D4_AMHH
D4_AMMM
D4_AMNT
D4_AMPT
D4_DA
D4_MDHH
D4_MDMM
D4_MDNT
D4_MDPT
D4_MO
D4_PMHH
D4_PMMM
D4_PMNT
D4_PMPT
D4_YR
D5_AMHH
D5_AMMM
D5_AMNT
D5_AMPT
D5_DA
D5_MDHH
D5_MDMM
D5_MDNT
D5_MDPT
D5_MO
D5_PMHH
D5_PMMM
D5_PMNT
D5_PMPT
D5_YR
D6_AMHH
D6_AMMM
D6_AMNT
D6_AMPT
D6_DA
D6_MDHH
D6_MDMM
D6_MDNT
D6_MDPT
D6_MO
D6_PMHH
D6_PMMM
D6_PMNT
D6_PMPT
D6_YR
D7_AMHH
D7_AMMM
D7_AMNT
D7_AMPT
D7_DA
D7_MDHH
D7_MDMM
D7_MDNT
D7_MDPT
D7_MO
D7_PMHH
D7_PMMM
D7_PMNT
D7_PMPT
D7_YR
DOSE
OTH_SP
REASON
STARTDA
STARTMO
STARTYR
STOPDA
STOPMO
STOPYR
ACTION
DBFU
DOSE
DRUGDA
DRUGHH
DRUGMM
DRUGMO
DRUGYR
DSPDA
DSPMO
DSPYR
DSTDA
DSTMO
DSTYR
MDOSE
MONGO
MSTPDA
MSTPMO
MSTPYR
MSTRTDA
MSTRTMO
MSTRTYR
MUNITS
ONGO
RELATE
SDYMED
Supplements
Data ElementVariables
Blood Transfusion REAC1-5
REACOTH
REACSP
REAS_OT
REAS_SP
REAS1
REAS10
REAS11
REAS2
REAS3
REAS4
REAS5
REAS6
REAS7
REAS8
REAS9
S3_PRHG
S3_TRAN
S3_TYPE
S3_UNITS
TRANNA
TRANTOT
TYPE
UNITS
UNITS
Chronic Transfusion THRPY
THRPYDA
THRPYMO
THRPYYR
Transfusion Complications
Data ElementVariables
Oxygen OXY
OXYC
S3_O2
S3_O2HI
S3_O2MX
Treatment S3_OTH
S3_OTHS
Data ElementVariables
6-Minute Walk Test AOPOST
AOPRE
BRGPOST
CLASS
DEVICE
DIAPOST
DIAPRE
DIST
DRUGDA
DRUGHH
DRUGMM
DRUGMO
DRUGYR
FRPOST
FRPRE
FRWALK
HRPOST
HRPRE
OSPOST
OSPRE
STARTHH
STARTMM
SUBSTOP
SYSPOST
SYSPRE
USE02
Data ElementVariables
ASCQ-Me Pain Episode
ASCQ-Me Pain Impact
Brief Pain Inventory (BPI) FOOTL
FOOTM
FOOTR
IQ2LLEGM
Q1
Q2ABDOC
Q2ABDOL
Q2ABDOM
Q2ABDOR
Q2BUTTL
Q2BUTTM
Q2BUTTR
Q2CHSTC
Q2CHSTL
Q2CHSTM
Q2CHSTR
Q2ELBL
Q2ELBM
Q2ELBR
Q2GEN
Q2GENM
Q2HANDL
Q2HANDM
Q2HANDR
Q2HEADC
Q2HEADL
Q2HEADM
Q2HEADR
Q2KNEEL
Q2KNEEM
Q2KNEER
Q2LARML
Q2LARMM
Q2LARMR
Q2LBCKC
Q2LBCKL
Q2LBCKM
Q2LBCKR
Q2LLEGL
Q2LLEGR
Q2NECK
Q2NECKM
Q2SHLDL
Q2SHLDM
Q2SHLDR
Q2UARML
Q2UARMM
Q2UARMR
Q2UBCKC
Q2UBCKL
Q2UBCKM
Q2UBCKR
Q2ULEGL
Q2ULEGM
Q2ULEGR
Q3
Q4
Q5
Q6
Q7
Q8
Q9A
Q9B
Q9C
Q9D
Q9E
Q9F
Q9G
PROMIS Neuropathic Pain Quality
PROMIS Nociceptive Pain Quality
PROMIS Pain Interference
Data ElementVariables
Child Health Questionnaire (CHQ)
Ladder of Life
Pediatric Quality of Life Inventory Child Report (ages 13-18) EMOFC1
EMOFC2
EMOFC3
EMOFC4
EMOFC5
PHYFC1
PHYFC2
PHYFC3
PHYFC4
PHYFC5
PHYFC6
PHYFC7
PHYFC8
SCHFC1
SCHFC2
SCHFC3
SCHFC4
SCHFC5
SOCFC1
SOCFC2
SOCFC3
SOCFC4
Pediatric Quality of Life Inventory Child Report (ages 8-12) EMOFC1
EMOFC2
EMOFC3
EMOFC4
EMOFC5
PHYFC1
PHYFC2
PHYFC3
PHYFC4
PHYFC5
PHYFC6
PHYFC7
PHYFC8
SCHFC1
SCHFC2
SCHFC3
SCHFC4
SCHFC5
SOCFC1
SOCFC2
SOCFC3
SOCFC4
SOCFC5
Pediatric Quality of Life Inventory Parent Report for Child (ages 13-18) EMOFP1
EMOFP2
EMOFP3
EMOFP4
EMOFP5
PHYFP1
PHYFP2
PHYFP3
PHYFP4
PHYFP5
PHYFP6
PHYFP7
PHYFP8
SCHFP1
SCHFP2
SCHFP3
SCHFP4
SCHFP5
SOCFP1
SOCFP2
SOCFP3
SOCFP4
SOCFP5
Pediatric Quality of Life Inventory Parent Report for Child (ages 8-12) EMOFP1
EMOFP2
EMOFP3
EMOFP4
EMOFP5
PHYFP1
PHYFP2
PHYFP3
PHYFP4
PHYFP5
PHYFP6
PHYFP7
PHYFP8
SCHFP1
SCHFP2
SCHFP3
SCHFP4
SCHFP5
SOCFP1
SOCFP2
SOCFP3
SOCFP4
SOCFP5
PROMIS Self-Efficacy for Managing Medications and Treatment
SF-36 Health Survey SFQ1
SFQ10
SFQ11A
SFQ11B
SFQ11C
SFQ11D
SFQ2
SFQ3A
SFQ3B
SFQ3C
SFQ3D
SFQ3E
SFQ3F
SFQ3G
SFQ3H
SFQ3I
SFQ3J
SFQ4A
SFQ4B
SFQ4C
SFQ4D
SFQ5A
SFQ5B
SFQ5C
SFQ6
SFQ7
SFQ8
SFQ9A
SFQ9B
SFQ9C
SFQ9D
SFQ9E
SFQ9F
SFQ9G
SFQ9H
SFQ9I
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