Sub-Domain: Disease or Treatment Related Events
CRF:
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 |
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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 | general-data-protection-regulation-gdpr | 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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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" |
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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 | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
Multiple Pre-Defined Values Selected |
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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 | general-data-protection-regulation-gdpr |
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" |