Cure Sickle Cell Initiative | Cure Sickle Cell

CDE Detailed Report

Disease: Sickle Cell Disease
Sub-Domain: Disease or Treatment Related Events
CRF: Acute Spleen

21 results.

CDE ID	CDE Name	Variable Name	Definition	Short Description	Additional Notes (Question Text)	Permissible Values	Description	Data Type	Disease Specific Instructions	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	Domain	CDASH Variable	CDASH Label	Prompt	Question Text	Data Type	CRF Completion Inst	SDTMIG Target Var	SDTMIG Target Map	Codelist Name	PVs	Query Display	List Style
C60122	Platelet count low value occurrence indicator	PlatletCtLowValOccurrInd	Indicator of whether the subject/participant's lowest platelet count value occurred during the splenic sequestration event being documented.	Indicator of whether the subject/participant's lowest platelet count value occurred during the splenic sequestration event being documented.	Platelet count nadir	No;Yes	No;Yes	Alphanumeric		Adult;Pediatric	Core	1.00	2021-01-15 10:06:53.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				FA	SPLSEQPLAT_OCCUR_FAORRES	FA Result or Finding in Original Units	Occurrence	What was the occurrence of the subject's lowest platelet measurement during the splenic sequestration episode?	Char	Record whether the subject's lowest platelet measurement occurred during the splenic sequestration episode by checking Yes or No.	FAORRES	FAORRES where FATESTCD = "OCCUR" and FATEST = "Occurrence" and FAOBJ = "Lowest Platelet Value"	(NY)	Yes; No	Question	Radio
C60133	Splenic scan result normality category	SplenicScanResultNormalityCat	Category of normality of the result of the splenic scan performed on the subject/participant.	Category of normality of the result of the splenic scan performed on the subject/participant.	Splenic scan results	Normal;Abnormal	Normal (radionuclide uptake);Abnormal (no radionuclide uptake)	Alphanumeric		Adult;Pediatric	Supplemental	1.00	2021-01-15 13:09:41.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				MO	SPLEN_INTP_MOORRES	Result or Finding in Original Units	Result	What was the result of the test?	Char	Record the interpretation of splenic normality based on the splenic scan.	MOORRES	MOORRES where MOTESTCD = "INTP" and MOTEST = "Interpretation" and MOMETHOD = "IMAGING"			Prompt
C60123	Packed red blood cell transfusion indicator	PRBCTransfusnInd	Indicator of whether the subject/participant received a packed red blood cell (PRBC) transfusion during the splenic sequestration episode being reported.	Indicator of whether the subject/participant received a packed red blood cell (PRBC) transfusion during the splenic sequestration episode being reported.	PRBC transfusion	No;Yes	No;Yes	Alphanumeric		Adult;Pediatric	Core	1.00	2021-01-15 10:12:11.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				PR	SPLSEQ_PRBCTRANS_PROCCUR	Procedure Occurrence	Packed Red Blood Cell Transfusion	Has the subject had a packed red blood cell transfusion during the splenic sequestion episode?	Char	Indicate if a packed red blood cell transfusion during the splenic sequestration episode was performed by checking Yes or No.	PROCCUR	PROCCUR where PRTRT = "PACKED RED BLOOD CELL TRANSFUSION" and PRINDC = "SPLENIC SEQUESTRATION"	(NY)	Yes; No	Question	Radio
C60113	Acute splenomegaly indicator	AcuteSplenomegalyInd	Indicator of whether the subject/participant presents with acute enlargement of the spleen.	Indicator of whether the subject/participant presents with acute enlargement of the spleen.	Acute splenomegaly	No;Yes	No;Yes	Alphanumeric		Adult;Pediatric	Core	1.00	2021-01-14 16:44:23.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				CE	ACCSPLEN_CEOCCUR	Clinical Event Occurrence	Acute Splenomegaly	Did the subject have acute splenomegaly?	Char	Indicate if acute splenomegaly has occurred/is occurring by checking Yes or No.	CEOCCUR	CEOCCUR where CETERM = "ACUTE SPLENOMEGALY"	(NY)	Yes; No	Prompt	Radio
C60124	Hemodynamic instability indicator	HemodynamicInstabilityInd	Indicator of whether the subject/participant exhibited hemodynamic instability during the splenic sequestration event being reported.	Indicator of whether the subject/participant exhibited hemodynamic instability during the splenic sequestration event being reported.	Hemodynamic instability	No;Yes	No;Yes	Alphanumeric		Adult;Pediatric	Core	1.00	2021-01-15 10:15:27.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				CE	SPLSEQ_HEMDYN_FAORRES	FA Result or Finding in Original Units	Occurrence	What was the occurrence of hemodynamic instability during the splenic sequestration episode?	Char	Record the occurrence of hemodynamic instability during the splenic sequestration episode by checking Yes or No.	FAORRES	FAORRES where FATESTCD = "OCCUR" and FATEST = "Occurrence" and FAOBJ = "Hemodynamic Instability"	(NY)	Yes; No	Question	Radio
C60114	Acute splenomegaly diagnosis date	AcuteSplenomegalyDxDate	Date on which the subject/participant was diagnosed with acute enlargement of the spleen.	Date on which the subject/participant was diagnosed with acute enlargement of the spleen.	Acute splenomegaly Date and Time (m m /d d/ y y y y)			Date or Date & Time		Adult;Pediatric	Core	1.00	2021-01-14 16:47:46.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Free-Form Entry				CE	ACCSPLEN_CESTDAT	Clinical Event Start Date	Acute Splenomegaly Start Date	What was the acute splenomegaly start date?	Char	Record the start date of the acute splenomegaly using this format (DD-MON-YYYY).	CESTDTC	CESTDTC where CETERM = "ACUTE SPLENOMEGALY" and CEOCCUR = "Y", otherwise NULL			Prompt
C60125	Imaging indicator	ImagingInd	Indicator of whether imaging was performed on the subject/participant.	Indicator of whether imaging was performed on the subject/participant.	Imaging done	No;Yes	No;Yes	Alphanumeric		Adult;Pediatric	Core	1.00	2021-01-15 10:43:27.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				MO	SPLEIMAG_MOPERF	Examination Performed	Spleen Assessed by Imaging	Was spleen size assessed by imagine?	Char	If the examination was performed as planned then select Yes, otherwise, select No.	MOSTAT	MOSTAT = "NOT DONE" when MOPERF = "N", if MOPERF = "Y" then MOSTAT = NULL where MOTESTCD = "SIZE" and MOLOC = "SPLEEN" and MOMETHOD = "IMAGING"	(NY)	Yes; No	Prompt	Radio
C60115	Spleen size physical examination indicator	SpleenSizePhysicalExamInd	Indicator of whether the size of the subject/participant's spleen was evaluated by physical examination.	Indicator of whether the size of the subject/participant's spleen was evaluated by physical examination.	Spleen size by PE	No;Yes	No;Yes	Alphanumeric		Adult;Pediatric	Core	1.00	2021-01-14 16:50:52.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				MO	ACCSPLEN_MOPERF	Examination Performed	Spleen Assessed by Physical Exam	Was spleen size assessed by physical examination?	Char	If the examination was performed as planned then select Yes, otherwise, select No.	MOSTAT	MOSTAT = "NOT DONE" when MOPERF = "N", if MOPERF = "Y" then MOSTAT = NULL where MOTESTCD = "SIZE" and MOLOC = "SPLEEN" and MOMETHOD = "PHYSICAL EXAMINATION"	(NY)	Yes; No	Prompt	Radio
C60126	Imaging spleen size measurement	ImgSpleenSizeMeasr	Measurement of the subject/participant's spleen size as determined by imaging.	Measurement of the subject/participant's spleen size as determined by imaging.	Spleen size			Numeric Values		Adult;Pediatric	Core	1.00	2021-01-15 10:45:20.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Free-Form Entry	0	30	centimeters	MO	SPLEN_LENGTH_MOORRES	Result or Finding in Original Units	Spleen Length	What was the length of the spleen?	Char	Record the length of the spleen by physical examination (cm below left costal margin)	MOORRES	MOORRES where MOTESTCD = "SIZE" and MOLOC = "SPLEEN" and MOMETHOD = "IMAGING" and MOORRESU = "cm"			Prompt
C60116	Spleen size physical examination measurement	SpleenSizePhysExamMeasr	Measurement of the size of the subject/participant's spleen by physical examination, reported as centimeters below the left costal margin.	Measurement of the size of the subject/participant's spleen by physical examination, reported as centimeters below the left costal margin.	Spleen size by PE (cm below left costal margin)			Numeric Values		Adult;Pediatric	Core	1.00	2021-01-14 16:53:52.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Free-Form Entry	0	10	Centimeters below left costal margin	MO	SPLEN_LENGTH_MOORRES	Result or Finding in Original Units	Spleen Length	What was the length of the spleen?	Char	Record the length of the spleen by physical examination (cm below left costal margin)	MOORRES	MOORRES where MOTESTCD = "SIZE" and MOLOC = "SPLEEN" and MOMETHOD = "PHYSICAL EXAMINATION" and MORRESU = "cm"			Prompt
C60127	Surgical splenectomy indicator	SurgicalSplenectomyInd	Indicator of whether the subject/participant's spleen was surgically removed.	Indicator of whether the subject/participant's spleen was surgically removed.	Surgical Splenectomy	No;Yes	No;Yes	Alphanumeric		Adult;Pediatric	Core	1.00	2021-01-15 10:47:24.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				PR	SPLENECT_PROCCUR	Procedure Occurrence	Splenectomy Performed	Has the subject had a splenectomy?	Char	Indicate if a splenectomy was performed by checking Yes or No.	PROCCUR	PROCCUR where PRTRT = "SPLENECTOMY"	(NY)	Yes; No	Prompt	Radio
C60117	Hypersplenism indicator	HypersplenismInd	Indicator of whether the subject/participant exhibits hypersplenism (overactivity of the spleen).	Indicator of whether the subject/participant exhibits hypersplenism (overactivity of the spleen).	Hypersplenism	No;Yes	No;Yes	Alphanumeric		Adult;Pediatric	Core	1.00	2021-01-15 09:49:11.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				CE	HYPSPLEN_CEOCCUR	Clinical Event Occurrence	Hypersplenism	Did the subject have hypersplenism?	Char	Indicate if hypersplenishm has occurred/is occurring by checking Yes or No.	CEOCCUR	CEOCCUR where CETERM = "HYPERSPLENISM"	(NY)	Yes; No	Prompt	Radio
C60128	Surgical splenectomy date	SurgicalSplenectomyDate	Date on which the subject/participant's spleen was surgically removed.	Date on which the subject/participant's spleen was surgically removed.	Surgical Splenectomy Date			Date or Date & Time		Adult;Pediatric	Core	1.00	2021-01-15 10:49:01.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Free-Form Entry				PR	SPLENECT_PRSTDAT	Procedure Start Date	Date	What was the procedure date ?	Char	Record the date the procedure was started or performed using this format (DD-MON-YYYY). Procedures performed during the study are expected to have a complete start date. Prior procedures that are exclusionary should have both a start and end date.	PRSTDTC	PRSTDTC where PRTRT = "SPLENECTOMY"			Prompt
C60118	Splenic sequestration episode count	SplenicSeqstrtnEpisodCt	Count of splenic sequestration episodes experienced by the subject/participant.	Count of splenic sequestration episodes experienced by the subject/participant.	Splenic sequestration episodes - 0,1,2, etc			Numeric Values		Adult;Pediatric	Core	1.00	2021-01-15 09:51:54.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Free-Form Entry	0	100	episodes	FA	SPLESEQ_EPSDNUM_FAORRES	FA Result or Finding in Original Units	Number of Episodes	What was the number of episodes of splenic sequestration experienced by the subject?	Char	Record the number of episodes of splenic sequestration experienced by the subject.	FAORRES	FAORRES where FATESTCD = "EPSDNUM" and FATEST = "Number of Episodes" and FAOBJ = "Splenic Sequestration"
C60129	Spleen function assessment indicator	SpleenFuncAssessmntInd	Indicator of whether the function of the subject/participant's spleen was assessed.	Indicator of whether the function of the subject/participant's spleen was assessed.	Was splenic function assessed?	No;Yes;Not applicable;Unknown	No;Yes;Not applicable;Unknown	Alphanumeric		Adult;Pediatric	Supplemental	1.00	2021-01-15 10:50:48.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected
C60119	Splenic sequestration abdominal pain indicator	SplncSqstrtnAbdmnlPnInd	Indicator of whether the subject/participant experienced abdominal pain during splenic sequestration episodes.	Indicator of whether the subject/participant experienced abdominal pain during splenic sequestration episodes.	Abdominal pain	No;Yes	No;Yes	Alphanumeric		Adult;Pediatric	Core	1.00	2021-01-15 09:55:36.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				CE	SPLSEQPAI_OCCUR_FAORRES	FA Result or Finding in Original Units	Occurrence	What was the occurrence of abdominal pain during the splenic sequestration episode?	Char	Record the occurrence of abdominal pain the subject experienced/is experiencing during the splenic sequestration episode by checking Yes or No.	FAORRES	FAORRES where FATESTCD = "OCCUR" and FATEST = "Occurrence" and FAOBJ = "Abdominal pain"	(NY)	Yes; No	Question	Radio
C60130	Spleen function test type	SpleenFunctionTestTyp	Type of test(s) performed to assess function of the spleen.	Type of test(s) performed to assess function of the spleen.	Select which splenic test was completed	Splenic scan;Pitted RBC score;Complete red blood cell count	Splenic scan;Pitted RBC score;Complete red blood cell count	Alphanumeric		Adult;Pediatric	Supplemental	1.00	2021-01-15 10:54:31.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Multiple Pre-Defined Values Selected
C60120	Splenic sequestration episode date	SplncSqstrtnEpsdDate	Date of the subject/participant's splenic sequestration episode.	Date of the subject/participant's splenic sequestration episode.	Date: (m m /d d/ y y y y)			Date or Date & Time	For each episode	Adult;Pediatric	Core	1.00	2021-01-15 09:57:38.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Free-Form Entry				CE	SPLSEQ_CESTDTC	Clinical Event Start Date	Start Date	What was the splenic sequestration start date?	Char	Record the start date of the [clinical event ] using this format (DD-MON-YYYY).	CESTDTC	CESTDTC where CETERM = "SPLENIC SEQUESTRATION"
C60131	Complete red blood cell count text	CompleteRBCCtTxt	Text field for specifying the complete red blood cell (RBC) count in cells microliter, including the exponent of 10 (i.e., 10^xx).	Text field for specifying the complete red blood cell (RBC) count in cells microliter, including the exponent of 10 (i.e., 10^xx).	Complete RBC			Alphanumeric	Report using this format: ___ ___ ___ ___ • ___ ___ x 10 ___ ___ cells/microliter	Adult;Pediatric	Supplemental	1.00	2021-01-15 12:57:14.0	Acute Spleen	Disease or Treatment Related Events	Spleen	30	Free-Form Entry				LB	RBC_LBORRES	Lab Result or Finding in Original Units	Result	What was the result of the test?	Char	Record RBC result.	LBORRES	LBORRES where LBTESTCD = "RBC" and LBTEST = "Erythrocytes"			Prompt
C60121	Hemoglobin low value occurrence indicator	HgbLowValOccurrInd	Indicator of whether the subject/participant's lowest hemoglobin (Hgb) value occurred during the splenic sequestration event being documented.	Indicator of whether the subject/participant's lowest hemoglobin (Hgb) value occurred during the splenic sequestration event being documented.	Hemoglobin nadir	No;Yes	No;Yes	Alphanumeric		Adult;Pediatric	Core	1.00	2021-01-15 10:06:53.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Single Pre-Defined Value Selected				FA	SPLSEQHGB_OCCUR_FAORRES	FA Result or Finding in Original Units	Occurrence	What was the occurrence of the subject's lowest hemoglobin (Hgb) measurement during the splenic sequestration episode?	Char	Record whether the subject's lowest hemoglobin (Hgb) measurement occurred during the splenic sequestration episode by checking Yes or No.	FAORRES	FAORRES where FATESTCD = "OCCUR" and FATEST = "Occurrence" and FAOBJ = "Lowest Hemoglobin Value"	(NY)	Yes; No	Question	Radio
C60132	Pitted red blood cell percent measurement	PittedRBCPctMeasr	Measurement of pitted red blood cells (RBC) as a percentage of total red blood cells.	Measurement of pitted red blood cells (RBC) as a percentage of total red blood cells.	Pitted RBC Score			Numeric Values		Adult;Pediatric	Supplemental	1.00	2021-01-15 13:03:41.0	Acute Spleen	Disease or Treatment Related Events	Spleen		Free-Form Entry	0	99.9	percent	LB	RBCPIRBC_LBORRES	Lab Result or Finding in Original Units	Result	What was the result of the test?	Char	Record the percent pitted erythrocytes/erythrocytes.	LBORRES	LBORRES where LBTESTCD = "RBCIPRBC" and LBTEST = "Pitted Erythrocytes/Erythrocytes" and LBORRESU = "%"			Prompt

21 results.