CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Disease Related Events
CRF: SCD Events of Special Interest Form (ESI)

30 results.
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type Source Form Set Form Field
C58774 First cerebrovascular event date FirstCerebrovascularEvntDate Date indicating the first occurrence of any significant cerebrovascular event during the assessment period. Date indicating the first occurrence of any significant cerebrovascular event during the assessment period. Date of first occurrence of any significant cerebrovascular event during this assessment period: Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-10 16:31:57.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESICERDT
C58821 Vaso-occlusive crisis new require hospital outpatient parenteral opioid code VsOccCrsNwReqHspOtptPntlOpCode Code indicating whether the patient experienced a new onset of painful vaso-occlusive crisis requiring hospitalization OR parental opioid drugs in the outpatient setting during the assessment period. Code indicating whether the patient experienced a new onset of painful vaso-occlusive crisis requiring hospitalization OR parental opioid drugs in the outpatient setting during the assessment period. Did the patient experience a new onset of painful vaso-occlusive crisis requiring hospitalization OR parenteral opioid drugs in the outpatient setting during this assessment period? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 14:41:28.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIVOC
C58757 New pulmonary hypertension code Newpulmonaryhypertensioncode Code indicating whether the event was a new episode of pulmonary hypertension during this assessment period. Code indicating whether the event was a new episode of pulmonary hypertension during this assessment period. Was this a new episode of pulmonary hypertension during this assessment period? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 12:53:23.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIINPULM
C58780 Renal compromise code RenalCompromiseCode Code indicating whether the patient experienced renal function compromise (proteinuria or increased creatinine grades greater than or equal to 2 per CTCAE version 4.0) during the assessment period Code indicating whether the patient experienced renal function compromise (proteinuria or increased creatinine grades greater than or equal to 2 per CTCAE version 4.0) during the assessment period Did the patient experience renal function compromise (proteinuria or increased creatinine grades greater than or equal to 2 per CTCAE version 4.0) during this assessment period? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-11 10:34:50.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIRENL
C58822 Painful vaso-occlusive crisis hospitalization count PnflVsOccCrsHospCt Count indicating the amount of times was the patient hospitalization for painful vaso-occlusive crisis during the assessment period. Count indicating the amount of times was the patient hospitalization for painful vaso-occlusive crisis during the assessment period. How many times was the patient hospitalized for painful vaso-occlusive crisis during this assessment period? Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 14:54:59.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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0 99 Times BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIVOCHT
C58760 New pulmonary hypertension date Newpulmonryhyprtensndate Indicate the date of the new episode of pulmonary hypertension. Indicate the date of the new episode of pulmonary hypertension. Date of new episode of pulmonary hypertension: Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-10 12:59:44.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESINPUDT
C58782 New onset proteinuria code NewOnsetProteinuriaCode Code indicating whether the patient experienced a new onset of proteinuria during the assessment period. Code indicating whether the patient experienced a new onset of proteinuria during the assessment period. Did the patient experience a new onset of proteinuria during this assessment period? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-11 10:44:41.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIPROT
C58831 Painful vaso-occlusive crisis require parenteral opioid drugs count PnflVsOccCrsReqPrtlOpDrgCt Count indicating the amount of times parenteral opioid drugs were required for the painful vaso-occlusive crisis in the outpatient setting during the assessment period. Count indicating the amount of times parenteral opioid drugs were required for the painful vaso-occlusive crisis in the outpatient setting during the assessment period. How many times were parenteral opioid drugs required for the painful vaso-occlusive crisis in the outpatient setting during this assessment period? Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 14:57:54.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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0 99 Times BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIVOCOT
C58761 Pulmonary hypertension diagnose code Pulmonryhyprtnsndiagnoscode Indicate whether the pulmonary hypertension was diagnosed via right heart catheterization or echocardiogram. Indicate whether the pulmonary hypertension was diagnosed via right heart catheterization or echocardiogram. How was pulmonary hypertension diagnosed? 2;1 Echocardiogram;Right heart catheterization Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 13:02:04.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIPDIAG
C58784 New onset proteinuria date NewOnsetProteinuriaDate Date indicating the new onset proteinuria. Date indicating the new onset proteinuria. Date of new onset of proteinuria: Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-11 10:46:51.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIPRODT
C58832 First vaso-occlusive crisis require hospital outpatient parenteral opioid date FstVsOccCrsReqHspOtptPnlOpDate Date indicating the first occurrence of painful vaso-occlusive crisis requiring hospitalization OR parenteral opioid drugs in the outpatient setting during the assessment period. Date indicating the first occurrence of painful vaso-occlusive crisis requiring hospitalization OR parenteral opioid drugs in the outpatient setting during the assessment period. Date of first occurrence of painful vaso-occlusive crisis requiring hospitalization OR parenteral opioid drugs in the outpatient setting during this assessment period: Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 15:33:45.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIVOCDT
C58763 Pulmonary hypertension intervention code Pulmonryhyprtnsnintrvntncode Indicate whether an intervention was required to treat pulmonary hypertension. Indicate whether an intervention was required to treat pulmonary hypertension. Was an intervention required to treat pulmonary hypertension? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 13:06:20.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESINTREQ
C58786 New onset increased creatinine code NewOnsetIncCreatinineCode Code indicating whether the patient experienced a new onset of increased creatinine (grades greater than or equal to 2 per CTCAE version 4.0) during this assessment period. Code indicating whether the patient experienced a new onset of increased creatinine (grades greater than or equal to 2 per CTCAE version 4.0) during this assessment period. Did the patient experience a new onset of increased creatinine (grades greater than or equal to 2 per CTCAE version 4.0) during this assessment? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-11 10:51:13.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESINCREA
C58833 Event advanced care intervention Intensive Care Unit admission code EvtAdvCrIntvnIntsCrUtAdmCode Code indicating whether any of the events reported above lead to an advanced care intervention or Intensive Care Unit admission/transfer as outlined in the AE reporting section of chapter 4 of the protocol. Code indicaitng whether any of the events reported above lead to an advanced care intervention or Intensive Care Unit admission/transfer as outlined in the AE reporting section of chapter 4 of the protocol. Did any of the events reported above lead to an advanced care intervention or Intensive Care Unit admission/transfer as outlined in the AE reporting section of chapter 4 of the protocol? 1;2;3 Yes;No;Not Applicable Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 15:36:27.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIAEICU
C58764 Treatment initiated code Treatmentinitiatedcode Indicate whether Sildenafil, Bosentan, Oxygen with RBC Transfusions, or another method was used to initiate treatment. Indicate whether Sildenafil, Bosentan, Oxygen with RBC Transfusions, or another method was used to initiate treatment. Select treatment initiated: 1;2;3;9 Sildenafil;Bosentan;Oxygen with red blood cell transfusions;Other Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 13:11:24.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIPUTRM
C58797 Onset increased creatinine date OnsetIncreasedCreatinineDate Date indicating when new onset of increased creatinine occurred. Date indicating when new onset of increased creatinine occurred. Date of new onset of increased creatinine: Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 11:34:11.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESICREDT
C58835 Event advanced care intervention Intensive Care Unit admission type EvtAdvCrInvIntCrUtAdmTyp Specify the event(s) that lead to an advanced care intervention or Intensive Care Unit admission/transfer as outlined in the AE reporting section of chapter 4 of the protocol. Specify the event(s) that lead to an advanced care intervention or Intensive Care Unit admission/transfer as outlined in the AE reporting section of chapter 4 of the protocol. Specify event(s): Alphanumeric Adult;Pediatric Proposed 1.00 2018-12-12 15:40:07.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event 255

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BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIAESP
C58765 Treatment initiated other text Treatmentinitiatedothertxt Indicate the specific treatment if other than Sildenafil, Bosentan, or Oxygen with RBC Transfusions. If "other" selected, specify the treatment indicated. Other, specify: Alphanumeric Adult;Pediatric Proposed 1.00 2018-12-10 13:13:20.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event 255

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BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESITRMSP
C58798 New onset avascular necrosis hip shoulder code NewOnstAvsclrNcrsHipShldrCode Code indicating whether the patient experienced a new onset of avascular necrosis of the hip or shoulder during the assessment period. Code indicating whether the patient experienced a new onset of avascular necrosis of the hip or shoulder during the assessment period. Did the patient experience a new onset of avascular necrosis of the hip or shoulder during this assessment period? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 11:36:32.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESINECR
C58836 Event special interest text ESITxt Comments Comments Comments: Alphanumeric Adult;Pediatric Proposed 1.00 2018-12-12 15:42:44.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event 255

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BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESICOMM
C58767 Significant cerebrovascular event code Signfcntcerebrovasculrevntcode Code indicating whether the patient experienced a new onset of a significant cerebrovascular event (stroke, transient ischemic attack, or seizure) during this assessment period. Code indicating whether the patient experienced a new onset of a significant cerebrovascular event (stroke, transient ischemic attack, or seizure) during this assessment period. Did the patient experience a new onset of a significant cerebrovascular event (stroke, transient ischemic attack, or seizure) during this assessment period? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 15:13:50.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESICEREB
C58817 New onset leg ulceration code NewOnsetLegUlcerationCode Code indicating whether the patient experienced a new onset of ulceration during the assessment period. Code indicating whether the patient experienced a new onset of ulceration during the assessment period. Did the patient experience a new onset of leg ulceration during this assessment period? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 13:57:09.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIULCR
C58768 New onset stroke count Newonsetstrokect Count indicating the amount of times the patient experienced a new onset of stroke during this assessment period. Count indicating the amount of times the patient experienced a new onset of stroke during this assessment period. How many times did the patient experience a new onset of stroke during this assessment period? Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 15:40:14.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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0 99 Times BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESISTRKT
C58818 New onset acute chest syndrome code NewOnstActChstSndrmHspCode Code indicating whether the patient experienced a new onset of acute chest syndrome requiring hospitalization during the assessment period. Code indicating whether the patient experienced a new onset of acute chest syndrome requiring hospitalization during the assessment period. Did the patient experience a new onset of acute chest syndrome requiring hospitalization during this assessment period? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 14:33:09.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIACS
C58769 New onset TIA count NewOnsetTIACt Count Indicating the amount of times the patient experienced a new onset of transient ischemic attack (TIA) during this assessment period. Count indicating the amount of times the patient experienced a new onset of transient ischemic attack (TIA) during this assessment period. How many times did the patient experience a new onset of transient ischemic attack (TIA) during this assessment period? Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 15:50:02.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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0 99 Times BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESITIAT
C58819 Hospitalization acute chest syndrome count HospAcuteChestSyndromeCt Code indicating the amount of times the patient was hospitalized for acute chest syndrome during the assessment period. Code indicating the amount of times the patient was hospitalized for acute chest syndrome during the assessment period. How many times was the patient hospitalized for acute chest syndrome during this assessment period? Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 14:36:28.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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0 99 Times BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIACST
C58749 Last contact date LastContactDate Indicate the date of the last study visit. Indicate the date of the last study visit. Date of last contact: Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-10 09:46:30.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESICNTDT
C58773 New onset seizure count NewOnsetSeizureCt Count indicating the amount of times the patient experienced a new onset of seizure during the assessment period. Count indicating the amount of times the patient experienced a new onset of seizure during the assessment period. How many times did the patient experience a new onset of seizure during this assessment period? Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 16:30:08.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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0 99 Times BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESISEIZT
C58820 First occurrence acute chest syndrome hospitalization date FstOcrnceActChstSyndrmHospDate Date indicating when the first occurrence of acute chest syndrome requiring hospitalization during the assessment period. Date indicating when the first occurrence of acute chest syndrome requiring hospitalization during the assessment period. Date of first occurrence of acute chest syndrome requiring hospitalization during this assessment period: Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 14:39:06.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

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BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIACSDT
C58756 Pulmonary hypertension code Pulmonaryhypertensioncode Code indicating whether the patient experienced pulmonary hypertension during the assessment period. Code indicating whether the patient experienced pulmonary hypertension during the assessment period. Did the patient experience pulmonary hypertension during this assessment period? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 12:48:12.0 SCD Events of Special Interest Form (ESI) Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESIPULM
30 results.
CSV