CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Safety Data
CRF: Iron Overload
Sub-Domain: Safety Data
CRF: Iron Overload
6 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 |
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| C58755 | Liver biopsy date | LiverBiopsyDate | Date on which liver biopsy was performed. | Date on which liver biopsy was performed. | Date of most recent liver biopsy | Date or Date & Time | Adult;Pediatric | Core | 1.00 | 2018-12-10 12:51:00.0 | Iron Overload | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLBXDT | |||||||||||||||||||||||||||||
| C60626 | Imaging MRI liver indicator | ImgMRILiverInd | Indicator of whether magnetic resonance imaging (MRI) of the liver was performed. | Indicator of whether magnetic resonance imaging (MRI) of the liver was performed. | Was a liver MRI performed? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-29 14:47:32.0 | Iron Overload | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60627 | Imaging MRI liver iron content status | ImgMRILiverFeContentStatus | Status of the liver iron content (LIC) obtained from magnetic resonance imaging (MRI) | Status of the liver iron content (LIC) obtained from magnetic resonance imaging (MRI) | If Yes, what was the liver iron content (LIC)? | Unknown;Known | Unknown;Known | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-29 14:49:32.0 | Iron Overload | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60628 | Imaging MRI liver iron content detemination method type | ImgMRILICDetermMethTyp | Type of method used for determination of liver iron content (LIC) in magnetic resonance imaging (MRI). | Type of method used for determination of liver iron content (LIC) in magnetic resonance imaging (MRI). | Known, by | R2*;T2* | R2*;T2* | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-29 14:54:01.0 | Iron Overload | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60629 | Liver biopsy iron result text | LiverBiopsyIronResultTxt | Text field for reporting the result of the laboratory iron test for liver biopsy. | Text field for reporting the result of the laboratory iron test for liver biopsy. | Iron Result | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-29 14:59:31.0 | Iron Overload | Safety Data | Adverse Events/Toxicities | 50 |
Free-Form Entry |
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| C60630 | Liver biopsy serum transferrin saturation percent value | LvrBiopsSrmTrnsfrrnSatPctVal | Value of the percentage of serum transferrin saturation detemined by laboratory anaylsis of liver biopsy sample. | Value of the percentage of serum transferrin saturation detemined by laboratory anaylsis of liver biopsy sample. | % Serum transferrin (% saturation) Result | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-29 15:01:38.0 | Iron Overload | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | percent serum transferrin (percent saturation) |
6 results.