CDE Detailed Report
Disease: cookie-policy
Sub-Domain: Disease or Treatment Related Events
CRF:

4 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
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"

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"

4 results.
CSV