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 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
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
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
21 results.
CSV