Details - CureSickleCell

Study ID	1009
Name	Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia
Contact Email	biolincc@imsweb.com
Acronym	MSH
Period	1992-2008
Design	Clinical Trial
Study PI	Samuel Charache, Michael Terrin
Institution	Multiple institutes
URL	https://biolincc.nhlbi.nih.gov/studies/MSH/
CTGovID	https://clinicaltrials.gov/ct2/show/NCT00000586
Funding Agency	NHLBI
Grant Number	UO1-HL45692, UO1-HL45696

Overview	The primary objective of MSH was to determine whether or not treatment with hydroxyurea titrated to maximum tolerated doses would reduce the frequency of vaso-occlusive (painful) crises by at least 50%. The principal end point was the occurrence of a vaso-occlusive (painful) crisis, defined as pain not due to another cause, lasting at least four hours and requiring parenteral (or equivalent doses of oral narcotics)) narcotics or non-steroidal anti-inflammatory drugs for relief. Occurrences of chest syndrome were counted as crises. Pain due to chronic conditions such as ankle ulcers, osteomyelitis or aseptic necrosis of bone was not counted as crises. The secondary objectives investigated the correlations of fetal hemoglobin (HbF) levels and other patient or treatment characteristics with the occurrence of vaso-occlusive (painful) crises, and the effect of treatment on the quality of life.
Focus Areas	1. Correlations of fetal hemoglobin (HbF) levels and other patient or treatment characteristics with the occurrence of vaso-occlusive (painful) crises, 2. Effect of treatment on the quality of life 3. Crises which occur between two years after study entry and theend of follow-up for each patient. 4. In-patient crises. 5. The duration of hospitalization for each in-patient crisis.Records will also be kept of the occurrence of events which areclearly-defined, sickle-related and not painful crises including a. Death; 6. b. Stroke; 7. c. Development of any indication resulting in treatment withchronic transfusion therapy, such as stroke or pulmonaryfailure; 8. d. New osteomyelitis, proved by culture, with consistent abnormalitieson x-ray and/or bone scan; 9. e. Development of a new ankle ulcer or recurrence of a previouslyhealed ankle ulcer; 10. f.Infections; 11. g.Aseptic necrosis of bone.
Outcomes	Occurrence of vaso-occlusive (painful) crisis [ Time Frame: Measured during the first 2 years a patient was enrolled in the study ]

Data Location	BioLINCC, BioData Catalyst
Biospecimen Available	Blood; DNA; Plasma; Serum;
Data Consent	Data sharing via BioLINCC; By signing the consent, the patient gives the MSH investigators permission to get records from any medical facility attended during the study. Data may be shared with the National Heart, Lung, and Blood Institute, the manufacturer of hydroxyurea, or the U.S. Food and Drug Administration (FDA).
Biospecimen Consent	Sample sharing via BIOLINCC; Genetic Use of Specimens Allowed
Contact Consent	NA
Genomic Data	No

Age Range	18-50
No. Participants	299
Inclusion Criteria	1. Men and women, ages 18 to 50, who had at least three emergency room visits or hospitalizations for sickle cell anemia during the year prior to recruitment. 2. Patients with greater than 20 crises per year were included. 3. Diagnosis of sickle cell anemia by gel electrophoresis conducted by a Core Laboratory. 4. Patients were required to successfully complete a 2 week “run-in” period comprised of two visits with baseline blood sample collections, completion of a two week diary and daily ingestion of a folic acid tablet.
Exclusion Criteria	1. They are unwilling to use contraception unless tubal ligation, hysterectomy or vasectomy has been performed (in the patient or partner(s)). 2. They are receiving prescriptions for more than 30 oxycodone capsules (or equivalent-see section 6.2) at a time from clinic personnel. 3. Creatinine is >1.7 mg/dL; 4. Transfusions have been received within 2 months of enrollment, or the patient is on a chronic transfusion program; or the patient is likely to begin chronic transfusion therapy in the next two years; 5. Active liver disease is present, as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>300 units or abnormal and increasing on serial samples; 6. There is a contraindication for potentially immunosuppressive therapy (HIV antibody testing is required for eligibility and a positive test will result in patient ineligibility); 7. Serum B12, ferritin or folate is abnormally low (patients are acceptable after treatment of deficiency states); 8. Hydroxyurea therapy has been or is currently being administered; 9. The patient is pregnant (tested for in all women before randomization) or breast-feeding; 10. S/ß0 thalassemia is known to be present; 11. The patient is receiving theophylline, androgen, estrogen, progestin (except for birth control), calcium channel blockers, danazol, or any other drug suspected to have an anti-sickling effect 12. The patient has a history of cerebrovascular accident (stroke) and has been on a chronic transfusion program 13. The patient has a history of congestive heart failure and has been on a chronic transfusion program 14. There has been failure to obtain informed consent 15. Hemoglobin-A greater than 15%.

Open All Close All

Clinical status (174)

Behavior (13)

Concept	Variables
Substance Use	ALC_CUR ALC_HIGH ALC_YRS CHEWTOB CIGARS CIGRTS LASTSMOK PACK_YRS PIPES SIXWEEKS SMOKE TOB_AGE TOBACCO

Blood (7)

Concept	Variables
Acute Anemic Episode
Aplastic Crisis	APLAS_HX
Bleeding	BLEED_HX BLEED_HX BLEED_HX
Other Blood Problem	HEMATO
Sickle Cell Disease	SC_DIAG SCD_DIAG

Cancer (4)

Concept	Variables
Cancer	CALEU_HX CANCER NEOP_HX NEOP_HX

Cardiovascular (4)

Concept	Variables
Aneurysm
Cardiac Failure	CHF_HX CHF_HX CHF_HX
Cardiovascular Problem	CARD_SYS
Heart Problem

Digestive (9)

Concept	Variables
Gastrointestinal Problem	GI_SYS GIDIS_HX GIDIS_HX GIDIS_HX INDIG_HX INDIG_HX
Hepatitis	HEPAT_HX
Liver Problem	HEP_FAIL HEPSEQ

Endocrine (0)

Family MedHx (1)

Concept	Variables
Family MedHx	FAMCA_HX

General Health (0)

Genitourinary (11)

Concept	Variables
Genitourinary Problem	HEMAT_HX HEMAT_HX HEMAT_HX HEMATUR IMPOT_HX URIN_SYS
Kidney Problem	REN_FAIL
Priapism	PRIAP PRIAP_HX PRIAP_HX PRIAP_HX
Renal Dialysis History

Immune (12)

Concept	Variables
Fever	FEVER
HIV Infection
Immune Problem	IMMUNO IMMUNO
Infection	CHPOX_HX CHPOX_HX HERPS_HX HERPS_HX HERPZ_HX HERPZ_HX INFECT INFECT SEPS_INF
Vaccination

Lymphatic (0)

Medical Event (23)

Concept	Variables
Adverse event	ADV_STP ALT_STP BTOX_STP CREA_STP GI_STP HAIR_STP OTH_RMK1 OTH_STP SKIN_STP
Death	AUTOPSY DEAD DTH_LOC EVT_CODE FATAL LOC_RMK VIS_DT VSTAT66
Disability Status	ACTIVITY
Hospitalization
Medical Event	DISPOSTN HAIR_L NAUSEA O_SX S_SX
Serious Adverse Event

Medical History (0)

Mental Health (16)

Concept	Variables
Anxiety
Depression
Emotional Health	DISTRES PSYCH SF_5A SF_5B SF_5C SF_9A SF_9B SF_9C SF_9D SF_9E SF_9F SF_9G SF_9H SF_9I SF_9J UNDSTD
Mental status
Psychiatric Disorder

Musculoskeletal (9)

Concept	Variables
Musculoskeletal Problem	EDEMA FISTULA MUSKEL NECF_HX NECH_HX
Osteomyelitis	OSTEO_HX OSTEO_HX
Osteonecrosis	NECF_HX NECH_HX
Rheumatic Diseases

Neurodevelopmental (0)

Neurologic (10)

Concept	Variables
Meningitis
Neurologic Event	DIZ_HEAD FAINT NAUSEA NEUR_SYS
Seizure
Stroke	SKIN_HX STRK_HX STROK_HX STROK_HX STROKE STROKE
Transient Ischemic Attack

Nutritional and Metabolic (0)

Ocular (1)

Concept	Variables
Ocular Problem	SCLERAL
Sickle Retinopathy

Oral (0)

Pain (9)

Concept	Variables
Abdominal Pain	LIV_LLQ LIV_LLQ LIV_LUQ LIV_LUQ LIV_RLQ LIV_RLQ LIV_RUQ LIV_RUQ
Headache
Management	MDVIS01

Reproductive (19)

Concept	Variables
Birth Outcome	LIVE_BTH PREG_TRM
Gestational Age
Menstruation
Pregnancy	CUR_PREG GRAVID P4_MOYR PREG PREG_STP PREG_STP PREGNT PREGNT PROTEC
Reproductive Behavior	ANDROG BIRTHCON DEPOPRO ESTROG IMPOT_HX IMPOT_HX NORPLANT PROTEC

Respiratory (9)

Concept	Variables
Acute Chest Syndrome	CHEST_SY CHST_HX CHST_HX
Asthma
Lung Disease	CHST_HX CPF_HX CPF_HX CPF_HX ENT_SYS PULM_SYS
Other Respiratory Problem

Skin (14)

Concept	Variables
Skin Problem	HRLOS_HX HRLOS_HX HRLOS_HX NAIL_HX OLDULCRS OTH_HX SKIN_HX SKIN_HX SKIN_R SKIN_SYS SKINULCR SKINULCR SKINULCR ULCR_HX

Sleep (0)

Surgery History (3)

Concept	Variables
Cardiovascular
Digestive	CHOL_HX CHOL_HX CHOL_HX
Genitourinary
Lymphatic
Musculoskeletal
Ocular
Respiratory
Surgery History

COVID-19 (0)

Diagnosis (0)

Impact (0)

Treatment (0)

Vaccination (0)

Demographics (39)

Demographics (3)

Concept	Variables
Address
Age
Ethnic Group	RACE
Gender	GENDER GENDER
Language
National Origin
Nuclear Family
Race

Social Determinants of Health (SDoH) (5)

Concept	Variables
Community	HOUSE HOUSE_FU ROOMS ROOMS_FU URBSUBRU
Individual

Socioeconomic Status (31)

Concept	Variables
Annual Income	INCOME_H INCOME_H INCOME_P INCOME_P_FU
Education	EDUCATN EDUCATN_FU
Employment Status	EMP_5YRS EMP_5YRS_FU EMPLYMNT EMPLYMNT_FU INDUSTRY INDUSTRY OCCUPATN OCCUPATN_FU UNEMP_MO UNEMP_YR UNEMP_YR_FU YRS_WRKD YRS_WRKD
Household	PERSONS PERSONS
Insurance	MEDICAID MEDICAID_FU MEDICARE MEDICARE_FU PRIVINS PRIVINS_FU STATEINS STATINS
Marital Status	MARITAL MARITAL_FU

Environmental Exposure (2)

Exposure (2)

Concept	Variables
Exposure	CAEXPRSK RADEXP
Lead Poisoning

Health Care (10)

Acute Care Utilization (7)

Concept	Variables
Facility Type	EMER_F IN_PAT MSHCL SC_FACIL
Provider Type
Quality of Care
Visit	DR_VIS SCH_CONT VIS_39

Health Services (0)

Healthcare utilization (3)

Concept	Variables
Country of Care
Facility Type
Quality of Care	TRIPTIME MODE_TRS DISTANCE

Hospitalization (0)

SCD Management (0)

Imaging (71)

Angiogram (0)

Catheterization (0)

CT Scan (43)

Concept	Variables
Abdomen
Bone
Brain
Chest	LOCALPF LOCCONSO LOCEMPHY LULOBE LULOBEPC OTHERABG OTHERBON OTHERCAR OTHERPLE OTHERPUL PLEURABS PLEURALE PULABSPE PULFIBRO PULINFAR DIFEMPHY DIFFUSEP DIFPLEUR EMPHYSEM RLLOBE RLLOBEPC RMLOBE RMLOBEPC RULOBE RULOBEPC AB_BONTH AB_HEART AB_HILUM AB_PLEUR AB_PULPA ARTENLAR BONEINFA BONYABSP BONYEROS CARDABSP CARDIOME FOCPLEUR GVABSPEC HILUMABS LLOBE LLOBE_ LMLOBE LMLOBEPC

Echocardiogram (24)

Concept	Variables
Echocardiogram	ATR_FIB ATR_FLU ATR_PMB C_LBBB C_RBBB ECG_NORM ECG_RECM ECGOLDMI ECGOT_SP ECGOTHR ECGOTHR I_RBBB LVH LVQSR OT_ARRHY P_PULM PVB Q_WVS RVH SIN_RHY SINUS_RT ST_DEP ST_ELEV TWV_INV

Electrocardiogram (ECG) (0)

Electrodiagnosis (0)

General Imaging (0)

MRI/MRA (0)

Nuclear Medicine Imaging (0)

PET scan (0)

Transcranial Doppler (TCD) (0)

Ultrasound (0)

X-Ray (4)

Concept	Variables
Abdomen
Biliary Tract
Chest	LUNGCLR LUNGCLR CXRAY_ST CXRAYINT
Extremities
Gallbladder
Liver
Skull

Parent/Caretaker (0)

Demographics (0)

Psychosocial (0)

Quality of Life (0)

Quality of Life (60)

Functional Status (49)

Concept	Variables
Behavior
Cognitive
Mental Health	ACTV_15V ANXI_41T BLUE_18D CHEE_38V DISC_32D EDGE_16T ENER_19V HELP_48D HPLS_21D LIVE_07V LOL5YA LOL5YH LOLNOW MISR_36D NERV_34T PEP 56V REST_27T SAD 14D TENS_02T UNEA_26T UNHA_05D VIGO_63V WEAR_49F WRTH_58D
Physical	SF_1 SF_10A SF_10B SF_10C SF_10D SF_2 SF_3A SF_3B SF_3C SF_3D SF_3E SF_3F SF_3G SF_3H SF_3I SF_3J SF_4A SF_4B SF_4C SF_4D
SCD Management
Sleep/Fatigue	BUSH_65F EXHA_40F FATG_29F WORN_04F
Social	SF_6

General Health (0)

Pain (11)

Concept	Variables
General Pain	PAIN_NSC PAIN01 SF_7 SF_8
Pain Attack	ADD_INFO CRISIS DIAG_A PAIN PAIN_EVT PAIN_SC UNCERT
Skeletal and Joint Pain

Tests (160)

Biopsy (0)

Blood (58)

Concept	Variables
Blood Differential Test	BASOS EOS LYMPHS MONOS NEUTS
Blood Gases	ACUTELTI BLOODGAS CARBOXYH COOXIMET EXPLAIN METHEM OXYHEM OXYSAT PACO2 PAO2 PERCTO2 PH ROOMAIR
Blood Smear	SLIDE
Blood Typing
Coagulation Test
Complete Blood Count	HGB MCH MCHC MCV PCV PLATELET RBC RBC_MYEL RDW RETIC_CT WBC
Comprehensive Metabolic Panel (CMP)	ALBUMIN ALK_PHOS ALT AST CALCIUM CREAT DIR_BILI GLUCOSE PHOSPH TOT_BILI TOT_PROT UREA_NIT URIC_A
Enzyme
General	B_HEM DIFVEN DNA NOVENA O_PROB R_HEM S_HEM S_PROB SERUM BLOODS CENTR
Hemoglobin Typing	AHGB HB_PATRN SC
Iron	FERRITIN

Cardiovascular (4)

Concept	Variables
Cardiovascular Test	MURMTYPE MURMURS S3GALLOP SINUS

Genitourinary (2)

Concept	Variables
Genitourinary Test
Urine Test	URI_RBC URI_WBC

Immune (0)

Microbiology Culture (0)

Musculoskeletal (0)

Neurologic (0)

Ocular (3)

Concept	Variables
Eye exam	SCL_ICT SCLERAL SCLERAL

Other (0)

Physical Exam (71)

Concept	Variables
Abdomen
Anthropometrics	bmi bmi bmi HEIGHT HEIGHT HGT WEIGHT WEIGHT WEIGHT WEIGHT WGT
Cardiovascular	S3GALLOP S3GALLOP SINUS SINUS MURMTYPE MURMTYPE MURMURS MURMURS
Extremities	FISTULA OLDULCRS EDEMA ULCR_HX
General	BLEED FEVER HAIRLOS SKINRSH SWEAT LYMP_ANC LYMP_ANC LYMP_ANC LYMP_CER LYMP_CER LYMP_CER LYMP_GRN LYMP_GRN LYMP_GRN LYMP_OTH LYMP_OTH LYMP_OTH INFECT
Liver	LIV_LLQ LIV_LUQ LIV_RLQ LIV_RUQ LIVER LIVER LIVER
Reproductive
Respiratory	LUNGCLR COUGH RESP RESPRATE RESPRATE
Spleen
Vital signs	CEL_FAR DBP DBP DBP DBP PULSE PULSE PULSE PULSE RESPRATE RESPRATE SBP SBP SBP SBP TEMP TEMP TEMP2

Reproductive (0)

Respiratory (22)

Concept	Variables
Pulmonary Function Test	BREATHCA CAPMEAS HEDILUTI LUNGCAP LUNGVOL OTHER PLETHYSM POSTFE25 POSTFE50 POSTFEV POSTFVC POSTPEF POSTSPIR PREFEF25 PREFEF50 PREFEV PREFVC PREPEF PRESPIRO RESIDCAP RESIDVOL SPECIFY
Respiratory Test

Therapeutics (147)

Medication (136)

Concept	Variables
Antibiotics	ANTBIOT
Asthma	THEOPH THEOPHYL
Blood Medication History	ANTIHYP CBLK DIURETIC
Cardiovascular
Compliance
Current Medication
Depression Medication History	ANTIDEPR FLUOXET
Hydroxyurea	CAPS_200 CAPS_500 HUCOM85 HUDOS85 HUTYP85 MISS_STP OTH_RMK2 OTHR_STP PLBO_STP RX_DOSE STOP_F33 TK_TIM TXINTC TXINTD TXINTR UNBL_STP
Medication	ACETAMIN ACETAMIN ANDROG ANTICONV ANTIDEPR ANTIHYP ASPIRIN ASPIRIN BENZOD BIRTHCON CBLK COD COD_DO COD_NA DEM DEM_DO DEM_NA DEPOPRO DIURETIC ESTROG FEN FEN_DO FLUOXET HISTAM HISTAM HYD HYD_DO HYD_NA IRON MOR MOR_DO MOR_NA NEUROLEP NORPLANT NSAID O_NARC OR1 OR1_DO OR1_NA OR2 OR2_DO OR2_NA OTHR_MED OTHR_MED OXY OXY_DO OXY_NA THEOPHYL
Neurologic Medication History	ANTICONV BENZOD NEUROLEP
Pain	COD_DAO COD_DOSO COD_O_NA COD_ORL DEM_DAO DEM_DAP DEM_DOSO DEM_DOSP DEM_O_NA DEM_ORL DEM_P_NA DEM_PAR DIL_DAO DIL_DAP DIL_DOSO DIL_DOSP DIL_O_NA DIL_ORL DIL_P_NA DIL_PAR FEN_DA FEN_DOS FEN_NA FENPAT KET_DA KET_NA KETDOS KETOR MEDS01 MOR_DAO MOR_DAP MOR_DOSO MOR_DOSP MOR_O_NA MOR_ORL MOR_P_NA MOR_PAR NS1_DA NS1_DOS NS1_NA NS1_RMK NSAID NSAID OR1_DAO OR1_DOSO OR1_NA OR1_RMK ORAL_NAR OXY_30 OXY_DAO OXY_DOSO OXY_O_NA OXY_ORL PA1_DAP PA1_DOSP PA1_NA PA1_PAR PA1_RMK PAR_NAR
SCD Medication	ANTSC
Sildenafil
Supplements	IRON

Surgery (0)

Transfusion (8)

Concept	Variables
Blood Transfusion	FVTRAN TRAN_STP TRANSF TRANSFUS UNTBL
Chronic Transfusion	CHR_TO CHR_TR CHTRAN
Transfusion Complications

Transplantation (0)

Treatment (3)

Concept	Variables
Discontinuation
Oxygen
Treatment	RADTHE TH_PHL TREATED

Study Publications

Open All Close All

Mental Health (25)

Concept	Variables
ASCQ-Me Emotional Impact
ASCQ-Me Social Functioning
Brief Resiliency Scale
NeuroQOL Fatigue
NIH Toolbox Loneliness
Pearlin Enhanced Self-Efficacy Scale
Profile of Mood States (POMS)	ACTV_15V ANXI_41T BLUE_18D BUSH_65F CHEE_38V DISC_32D EDGE_16T ENER_19V EXHA_40F FATG_29F HELP_48D HPLS_21D LIVE_07V MISR_36D NERV_34T PEP 56V REST_27T SAD 14D TENS_02T UNEA_26T UNHA_05D VIGO_63V WEAR_49F WORN_04F WRTH_58D
PROMIS Anger
PROMIS Anxiety
PROMIS Depression
PROMIS Emotional Distress- Depression
PROMIS Emotional Support
PROMIS Fatigue
PROMIS Global Mental Health
PROMIS Satisfaction with Participation in Discretionary Social Activities

Neurodevelopment (0)

Neuropsychological (0)

Pain (0)

Physical Function (0)

Psychosocial (0)

Quality of Care (0)

Quality of Life (40)

Concept	Variables
ASCQ-Me SCD Medical History Checklist
ASCQ-Me Sexual Health
Child Health Questionnaire (CHQ)
Ladder of Life	LOL5YA LOL5YH LOLNOW
Pediatric Quality of Life Inventory (PedsQL) (ages 1-12ms)
Pediatric Quality of Life Inventory (PedsQL) (ages 13-24ms)
Pediatric Quality of Life Inventory (PedsQL) (ages 2-4ys)
Pediatric Quality of Life Inventory (PedsQL) (ages 5-7)
Pediatric Quality of Life Inventory Child Report (ages 13-18)
Pediatric Quality of Life Inventory Child Report (ages 8-12)
Pediatric Quality of Life Inventory Parent Report for Child (ages 13-18)
Pediatric Quality of Life Inventory Parent Report for Child (ages 8-12)
PROMIS Global Health
PROMIS Global Physical Health
PROMIS Self-Efficacy for Managing Medications and Treatment
SF-36 Health Survey	SF_1 SF_10A SF_10B SF_10C SF_10D SF_2 SF_3A SF_3B SF_3C SF_3D SF_3E SF_3F SF_3G SF_3H SF_3I SF_3J SF_4A SF_4B SF_4C SF_4D SF_5A SF_5B SF_5C SF_6 SF_7 SF_8 SF_9A SF_9B SF_9C SF_9D SF_9E SF_9F SF_9G SF_9H SF_9I SF_9J UNDSTD

Sleep (0)

Technology Support (0)

Study Documentation Select All	1. Clinical_Protocol 2. EXT-1_Protocol 3. PFU_Protocol
Forms Select All	1. Form 01-Eligibility Screening Form I 2. Form 02-Eligibility Screening Form II 3. Form 03-Demographics 4. Form 04-Medical Examination and History 5. Form 05-Patient Diary 6. Form 07-Gel Electrophoresis Report 7. Form 08-Request for Enrollment 8. Form 09-Treatment Initiation 9. Form 11-Health Status Survey 10. Form 12-Profile of Mood States and Ladder of Life 11. Form 14-Patients Usual Residence 12. Form 20-Follow-Up Visit 13. Form 22-Missed Visit 14. Form 23-Six-Month Medical Review and Examination 15. Form 25-Medical Contact 16. Form 30-Toxicity Review 17. Form 31-Study Treatment Inventory 18. Form 32-Initiation of Treatment Stop Order 19. Form 33-Patient Contact for Treatment Stop Order Office 20. Form 34-Patient Contact for Treatment Stop Order Clinic 21. Form 35-Restart Treatment Order 22. Form 37-Resume Tratement Order 23. Form 39-Four-Week Telephone Follow-Up 24. Form 44-Crisis Review Committee Event Classification Form 25. Form 45-Death Notification 26. Form 70 Study Close-Out for Investigators 27. Form 73 Study Close-Out for Clinic Director 28. Form 74-Study Close-Out for MSH Assistant Coordinator 29. Form 75-Study Close-Out for Participant 30. FU-Y1-5-Form 40-Patient Enrollment 31. FU-Y1-5-Form 41-Demographics 32. FU-Y1-5-Form 42-Health Status Questionnaire 33. FU-Y1-5-Form 43-Medical Review and Examination 34. FU-Y1-5-Form 44 Rev4-Hydroxyurea Review 35. FU-Y1-5-Form 45-Protocol Review and Collection of Samples 36. FU-Y1-5-Form 47-Chest X-Ray Summary 37. FU-Y1-5-Form 48-ECG Summary 38. FU-Y1-5-Form 49-Local Laboratory Report 39. FU-Y1-5-Form 50-Patient Event 40. FU-Y1-5-Form 55-Event Classification 41. FU-Y6-9-Form 41-Demographics (1) 42. FU-Y6-9-Form 42-Health Status Questionnaire 43. FU-Y6-9-Form 43-Medical Review and Examination 44. FU-Y6-9-Form 44-Hydroxyurea Review 45. FU-Y6-9-Form 45-Protocol Review and Collection of Samples 46. FU-Y6-9-Form 46-Offspring Review 47. FU-Y6-9-Form 47-Chest X-Ray Summary 48. FU-Y6-9-Form 48-ECG Summary 49. FU-Y6-9-Form 49-Local Laboratory Report 50. FU-Y6-9-Form 50-Patient Event 51. FU-Y6-9-Form 66-Status of Patients Not Enrolled 52. FU-Y6-9-Form 67-Arterial Blood Gases Analysis 53. FU-Y6-9-Form 68-Spirometry Data Form 54. FU-Y6-9-Form 69-HRCT of the Chest 55. FU-Y6-9-Form 70-Patient Enrollment

Working...

Metadata Catalog

Study Detail

Study Publications