CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Disease or Treatment Related Events
CRF: Acute Anemia

22 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
C60348 Transfusion simple quantity unit of measure TransfusionSimpleQuantityUOM Unit of measure of the quantity of blood provided to the subject/participant during a simple (non-exchange) transfusion. Unit of measure of the quantity of blood provided to the subject/participant during a simple (non-exchange) transfusion. Simple (how much?) Alphanumeric Adult Core 1.00 2021-01-14 15:01:08.0 Acute Anemia Disease or Treatment Related Events Anemia 50

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C60101 Anemia cause reason AnemiaCauseRsn Reason for or cause of the subject/participant's anemia. Reason for or cause of the subject/participant's anemia. Cause Surgical;Blood Loss;Infection;Parvovirus Aplastic Crisis;Sequestration (splenic, hepatic);Myelosuppression;Hemolysis Surgical;Blood Loss;Infection;Parvovirus Aplastic Crisis;Sequestration (splenic, hepatic);Myelosuppression;Hemolysis Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 14:38:44.0 Acute Anemia Disease or Treatment Related Events Anemia

Multiple Pre-Defined Values Selected

C60349 Hydroxyurea dose postpone duration unit of measure HUDosePostponeDurUOM Unit of measure for the duration for which the administration of hydroxyurea (HU) to the subject/participant was postponed. Unit of measure for the duration for which the administration of hydroxyurea (HU) to the subject/participant was postponed. Hydroxyurea how long? (weeks, months) Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 14:34:55.0 Acute Anemia Disease or Treatment Related Events Anemia 25

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C59968 Platelet count value PlateletCountVal Value of the count of platelets in the subject/participant's complete blood cell (CBC) sample. Value of the count of platelets in the subject/participant's complete blood cell (CBC) sample. Platelet Count Value Numeric Values Adult;Pediatric Core 1.00 2020-09-01 13:36:15.0 Acute Anemia Disease or Treatment Related Events Anemia

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CIBMTR n/a Form 2031 revision 2 15: Platelets
C60102 Infection organism name InfectionOrganismName Name of the infectious organism present in the subject/participant. Name of the infectious organism present in the subject/participant. If Infection – Organism if known Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 14:47:18.0 Acute Anemia Disease or Treatment Related Events Anemia 100

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C60092 Hemoglobin low value HgbLowVal Value of the lowest measurement of the subject/participant's hemoglobin. Value of the lowest measurement of the subject/participant's hemoglobin. Hemoglobin Nadir Numeric Values Adult;Pediatric Core 1.00 2021-01-14 13:00:29.0 Acute Anemia Disease or Treatment Related Events Anemia

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C60103 Infection viral titer text InfectionViralTiterTxt Text describing the viral titers performed for the infection present in the subject/participant. Text describing the viral titers performed for the infection present in the subject/participant. If Infection – viral titers Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 14:49:25.0 Acute Anemia Disease or Treatment Related Events Anemia 255

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C60093 Reticulocyte count ReticulocyteCt Count of reticulocytes Count of reticulocytes Reticulocyte Count Value Numeric Values Adult;Pediatric Core 1.00 2021-01-14 13:06:05.0 Acute Anemia Disease or Treatment Related Events Anemia

Free-Form Entry

C60104 Transfusion required indicator TransfusnRequirdInd Indicator of whether the subject/participant requires a transfusion because of his or her anemia. Indicator of whether the subject/participant requires a transfusion because of his or her anemia. Transfusion required? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 14:52:13.0 Acute Anemia Disease or Treatment Related Events Anemia

Single Pre-Defined Value Selected

C60094 Reticulocyte count unit of measure ReticulocyteCtUOM Unit of measure for the subject/participant's reticulocyte count as recorded using the data element "Reticulocyte count". Unit of measure for the subject/participant's reticulocyte count as recorded using the data element "Reticulocyte count". Reticulocyte Count Units Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 13:07:35.0 Acute Anemia Disease or Treatment Related Events Anemia 50

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C60105 Transfusion exchange type indicator TransfusionExchangeTypeInd Indicator of whether the subject/participant required an exchange-type transfusion. Indicator of whether the subject/participant required an exchange-type transfusion. Exchange No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 14:55:27.0 Acute Anemia Disease or Treatment Related Events Anemia

Single Pre-Defined Value Selected

C60095 Platelet count unit of measure PlateletCtUOM Unit of measure for the count of platelets. Unit of measure for the count of platelets. Platelet Count Units Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 13:12:42.0 Acute Anemia Disease or Treatment Related Events Anemia 50

Free-Form Entry

C60106 Transfusion simple type indicator TransfusionSimpleTypeInd Indicator of whether the subject/participant required a simple-type transfusion. Indicator of whether the subject/participant required a simple-type transfusion. Simple No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 14:55:27.0 Acute Anemia Disease or Treatment Related Events Anemia

Single Pre-Defined Value Selected

C60096 Lactic acid dehydrogenase measurement value LDHMeasrVal Value of the measurement of the subject/participants lactic acid dehydrogenase (LDH). Value of the measurement of the subject/participants lactic acid dehydrogenase (LDH). LDH Value Numeric Values Adult;Pediatric Core 1.00 2021-01-14 13:15:48.0 Acute Anemia Disease or Treatment Related Events Anemia

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C60107 Transfusion simple quantity text TransfusionSimpleQuantityTxt Text field for reporting the quantity of blood provided to the subject/participant during a simple (non-exchange) transfusion. Text field for reporting the quantity of blood provided to the subject/participant during a simple (non-exchange) transfusion. Simple (how much?) Alphanumeric

Specify unit of measurement.

Adult;Pediatric Core 1.00 2021-01-14 15:01:08.0 Acute Anemia Disease or Treatment Related Events Anemia 50

Free-Form Entry

C60097 Lactic acid dehydrogenase measurement unit of measure LDHMeasrUOM Unit of measurement for the measurement of the subject/participant's lactic acid dehydrogenase (LDH) Unit of measurement for the measurement of the subject/participant's lactic acid dehydrogenase (LDH) LDH Units Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 13:17:31.0 Acute Anemia Disease or Treatment Related Events Anemia 50

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C60108 Anemia associated condition type AnemiaAssocConditionTyp Types of conditions associated with anemia with which the subject/participant presents. Types of conditions associated with anemia with which the subject/participant presents. Associated conditions – e.g., acute chest Acute chest syndrome Acute chest syndrome Alphanumeric

Select all that apply.

Adult;Pediatric Core 1.00 2021-01-14 15:05:29.0 Acute Anemia Disease or Treatment Related Events Anemia

Multiple Pre-Defined Values Selected

C60098 Hydroxyurea receive indicator HURcvInd Indicator of whether the subject/participant is receiving hydroxyurea (HU). Indicator of whether the subject/participant is receiving hydroxyurea (HU). On HU? No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 13:20:17.0 Acute Anemia Disease or Treatment Related Events Anemia

Single Pre-Defined Value Selected

C60109 Anemia associated condition type other text AnemiaAssocConditionTypOTH The free-text field related to "Anemia associated condition type" for specifying associated conditions not listed. The free-text field related to "Anemia associated condition type" for specifying associated conditions not listed. Other Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 15:05:29.0 Acute Anemia Disease or Treatment Related Events Anemia 255

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C60099 Hydroxyurea dose postpone indicator HUDosePostponeInd Indicator of whether the administration of the hydroxyurea (HU) dose was postponed. Indicator of whether the administration of the hydroxyurea (HU) dose was postponed. Hydroxyurea doses held? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-01-14 14:32:57.0 Acute Anemia Disease or Treatment Related Events Anemia

Single Pre-Defined Value Selected

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 Adult;Pediatric Core 1.00 2021-01-14 15:47:54.0 Acute 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"

C60100 Hydroxyurea dose postpone duration text HUDosePostponeDurTxt Text field for recording the duration for which the administration of hydroxyurea (HU) to the subject/participant was postponed. Text field for recording the duration for which the administration of hydroxyurea (HU) to the subject/participant was postponed. Hydroxyurea how long? (weeks, months) Alphanumeric

Specify units.

Adult;Pediatric Core 1.00 2021-01-14 14:34:55.0 Acute Anemia Disease or Treatment Related Events Anemia 25

Free-Form Entry

22 results.
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