Sub-Domain: Disease or Treatment Related Events
CRF: Chronic Anemia
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C60110 | Hemoglobin change from baseline grade | HgbChangFromBslnGrade | Grade of change in subject/participant's hemoglobin from steady-state baseline. | Grade of change in subject/participant's hemoglobin from steady-state baseline. | Change from baseline | Grade 1;Grade 2;Grade 3;Grade 4;Grade 5 | Grade 1 > 1gm/dl decrease from baseline;Grade 2 > 2gm/dl decrease from baseline;Grade 3 > 3gm/dl decrease from baseline or < 6gm/dl or transfusion indicated;Grade 4 > Life threatening consequences, urgent intervention needed;Grade 5 > Death | Alphanumeric |
Since the CTCAE was not developed for individuals with chronic hemolytic anemia the following proportional scale can be used based on baseline hemoglobin at steady state |
Adult;Pediatric | Core | 1.00 | 2021-01-14 15:47:54.0 | Chronic Anemia | Disease or Treatment Related Events | Anemia |
Single Pre-Defined Value Selected |
LB | HGB_LBTOX |
Lab Toxicity |
Toxicity |
What is the description of the toxicity? |
Use of this CDE on the Chronic Anemia form is not recommend if this result is already collected elsewhere in the clinical database (e.g., on an laboratory specific form). Data should not be double collected. |
LBTOX | Char | Record the description of the toxicity. |
LBOTX where LBTESTCD = "HGB" |
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| C60134 | Erythropoietin measured indicator | ErythropoietinMeasrInd | Indicator of whether the subject/participant's erythropoietin (EPO) level was measured. | Indicator of whether the subject/participant's erythropoietin (EPO) level was measured. | Was an erythropoietin (EPO) level obtained? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-15 13:21:31.0 | Chronic Anemia | Disease or Treatment Related Events | Anemia |
Single Pre-Defined Value Selected |
LB | EPO_PERF |
Lab Performed |
Lab Performed; Sample Collected |
Was the sample collected?; Was the lab performed? |
Use of this CDE on the Chronic Anemia form is not recommend if this result is already collected elsewhere in the clinical database (e.g., on an laboratory specific form). Data should not be double collected. |
LBSTAT | Char | Indicate whether or not lab specimen was collected or measurement performed. | ||||||||||||||||||||||
| C60135 | Erythropoietin measurement | ErythropoietinMeasr | Measurement of the subject/participant's erythropoietin (EPO) level. | Measurement of the subject/participant's erythropoietin (EPO) level. | EPO level: ___ ___ ___ IU/L | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-01-15 13:25:23.0 | Chronic Anemia | Disease or Treatment Related Events | Anemia |
Free-Form Entry |
0 | 999 | international units per liter | LB | EPO_LBORRES; EPO_LBORRESU |
Lab Result or Finding in Original Units; Lab Original Units |
(Result); Unit |
What was the result of the lab test?; What was the unit of the lab result? |
LBORRES; LBORRESU | Char; Char | Record laboratory test result.; Record or select the original unit in which these data were collected. |
LBORRES where LBTESTCD = "EPO"; LBORRESU where LBTESTCD = "EPO" |
; (UNIT) | ; IU/L | Prompt; Prompt | ||||||||||||||||||
| C60136 | Erythropoietin measurement date | ErythropoietinMeasrDate | Date on which the subject/participant's erythropoietin (EPO) level was measured. | Date on which the subject/participant's erythropoietin (EPO) level was measured. | Date sample drawn | Date or Date & Time | Adult;Pediatric | Core | 1.00 | 2021-01-15 13:27:21.0 | Chronic Anemia | Disease or Treatment Related Events | Anemia |
Free-Form Entry |
LB | EPO_LBDAT |
Specimen Collection Date |
Collection Date |
What was the date of the lab specimen collection? |
Use of this CDE on the Chronic Anemia form is not recommend if this result is already collected elsewhere in the clinical database (e.g., on an laboratory specific form). Data should not be double collected. |
LBDTC | Char | Record the date of specimen collection using this format (DD-MON-YYYY). |
LBDTC where LBTESTCD = "EPO" |
