CDE Detailed Report
Disease: cookie-policy
Sub-Domain: Disease Related Events
CRF:
Sub-Domain: Disease Related Events
CRF:
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 | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 | |||||||||||||||||||||||||||
| 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 |
Free-Form Entry |
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 |
30 results.