CDE Detailed Report

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CDE ID CDE Name Variable Name Definition Short Description 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 / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C58610 Chemical therapy intra-arterial indicator ChmThrpyIntraartInd Indicates if intra-arterial chemical therapy was performed Indicates if intra-arterial chemical therapy was performed Intra-arterial chemical therapy performed: Yes;No Yes;No Alphanumeric

Received intra-arterial chemical agent for treatment of intracranial vasospasm

Adult;Pediatric Supplemental 1.00 2018-10-30 09:35:37.0 Rescue Therapy [php] [php_1]

Single Pre-Defined Value Selected

C58611 Chemical therapy intra-arterial vasodilator type ChmThrpyIntraartVasodilTyp Type of vasodilator utilized for intra-arterial chemical therapy Type of vasodilator utilized for intra-arterial chemical therapy Type of vasodilator used for intra-arterial chemical therapy: Verapamil;Nicardipine;Papaverine;Milrinone;Other, specify Verapamil;Nicardipine;Papaverine;Milrinone;Other, specify Alphanumeric

Type of vasodilator delivered for catheter-based intra-arterial chemical therapy of vasospasm

Adult;Pediatric Supplemental 1.00 2018-10-30 10:29:17.0 Rescue Therapy [php] [php_1]

Single Pre-Defined Value Selected

C58612 Chemical therapy intra-arterial adverse clinical exam change type ChmThrpyIntraarAdClnExChngTyp The element related to adverse clinical exam changes directly related to the intra-arterial therapy The element related to adverse clinical exam changes directly related to the intra-arterial therapy Adverse clinical exam changes directly related to intra-arterial chemical therapy: Transient (less than 24 hours);Prolonged/permanent;None Transient (less than 24 hours);Prolonged/permanent;None Alphanumeric

Transient (less than 24 hour) or prolonged/permanent neurological deterioration defined as the occurrence of focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the Glasgow Coma Scale (either on the total score or on one of its individual components [eye, motor on either side, verbal]) directly due to catheter based intra-arterial chemical therapy for intracranial vasospasm

Adult;Pediatric Supplemental 1.00 2018-10-30 11:43:44.0 Rescue Therapy [php] [php_1]

Single Pre-Defined Value Selected

C58613 Chemical therapy intra-arterial procedural adverse event type ChmThrpyIntraartProcAETyp Type of procedural adverse events related to intra-arterial chemical therapy that occurred Type of procedural adverse events related to intra-arterial chemical therapy that occurred Procedural adverse events related to intra-arterial chemical therapy: Hypotension;Hyperfusion;Perforation;Vessel dissection;Embolic event;Other, specify Hypotension;Hyperfusion;Perforation;Vessel dissection;Embolic event;Other, specify Alphanumeric

Adverse event directly resulting from catheter-based administration of chemical agent for intracranial vasospasm treatment. Hypotension indicates hypotension requiring cessation of therapy

Adult;Pediatric Supplemental 1.00 2018-10-30 12:20:42.0 Rescue Therapy [php] [php_1]

Multiple Pre-Defined Values Selected

C58614 Mechanical balloon angioplasty intra-arterial indicator MchBlAngIntraartInd Indicates if intra-arterial mechanical balloon angioplasty was performed Indicates if intra-arterial mechanical balloon angioplasty was performed Intra-arterial mechanical balloon angioplasty perfomed: Yes;No Yes;No Alphanumeric

Received intra-arterial mechanical balloon angioplasty for treatment of intracranial vasospasm

Adult;Pediatric Supplemental 1.00 2018-10-30 12:59:50.0 Rescue Therapy [php] [php_1]

Single Pre-Defined Value Selected

C58615 Mechanical balloon angioplasty adverse clinical exam change indicator MchBlAngAdClinExamChngInd Indicates if adverse clinical exam changes directly related to the mechanical treatment were seen Indicates if adverse clinical exam changes directly related to the mechanical treatment were seen Adverse clinical exam changes directly related to mechanical treatment: Transient (less than 24 hours);Prolonged/permanent;None Transient (less than 24 hours);Prolonged/permanent;None Alphanumeric

Transient (less than 24 hour) or prolonged/permanent neurological deterioration defined as the occurrence of focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the Glasgow Coma Scale (either on the total score or on one of its individual components [eye, motor on either side, verbal]) directly due to catheter based intra-arterial mechanical therapy for intracranial vasospasm

Adult;Pediatric Supplemental 1.00 2018-10-30 13:41:11.0 Rescue Therapy [php] [php_1]

Single Pre-Defined Value Selected

C58616 Mechanical balloon angioplasty procedural adverse event type MchBlAngProcAETyp Type of procedural adverse events related to mechanical angioplasty that occurred Type of procedural adverse events related to mechanical angioplasty that occurred Procedural adverse events related to mechanical angioplasty: Perforation;Embolic event;Other, specify;Dissection Perforation;Embolic event;Other, specify;Dissection Alphanumeric

Adverse event directly resulting from catheter-based mechanical angioplasty for intracranial vasospasm treatment.

Adult;Pediatric Supplemental 1.00 2018-10-30 13:46:42.0 Rescue Therapy [php] [php_1]

Multiple Pre-Defined Values Selected

C58627 Chemical therapy intra-arterial vasodilator other text ChmThrpyIntraartVasodilOTH Free-text field related to other type of vasodilator utilized for intra-arterial chemical therapy Free-text field related to other type of vasodilator utilized for intra-arterial chemical therapy Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2018-11-05 10:40:54.0 Rescue Therapy [php] [php_1] 255

Free-Form Entry

C58628 Chemical therapy intra-arterial procedural adverse event other text ChmThrpyIntraartProcAEOTH Free-text field related to other type of procedural adverse events related to intra-arterial chemical therapy Free-text field related to other type of procedural adverse events related to intra-arterial chemical therapy Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2018-11-05 11:16:50.0 Rescue Therapy [php] [php_1] 255

Free-Form Entry

C58608 Chemical mechanical intra-arterial balloon angioplasty indicator ChmMchIntraartBlAngInd Indicates if intra-arterial chemical or mechanical balloon angioplasty was performed Indicates if intra-arterial chemical or mechanical balloon angioplasty was performed Intra-arterial chemical or mechanical balloon angioplasty performed: Yes;No Yes;No Alphanumeric

Received intra-arterial chemical agent or mechanical balloon angioplasty for treatment of intracranial vasospasm

Adult;Pediatric Supplemental 1.00 2018-10-25 13:28:01.0 Rescue Therapy [php] [php_1]

Single Pre-Defined Value Selected

C58629 Mechanical balloon angioplasty procedural adverse event other text MchBlAngProcAEOTH Free-text field related to type of procedural adverse events related to mechanical angioplasty that occurred Free-text field related to type of procedural adverse events related to mechanical angioplasty that occurred Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2018-11-05 11:21:00.0 Rescue Therapy [php] [php_1] 255

Free-Form Entry

C58609 Chemical mechanical therapy subarachnoid hemorrhage day count ChemMechThrpySAHDyCt Number of days elapsed since the subarachnoid hemorrhage event that chemical or mechanical therapy is being performed Number of days elapsed since the subarachnoid hemorrhage event that chemical or mechanical therapy is being performed Subarachnoid hemorrhage (SAH) day number for chemical or mechanical therapy: Numeric Values

Day after SAH on which the chemical or mechanical therapy was performed (day of SAH starts at 0)

Adult;Pediatric Supplemental 1.00 2018-10-25 13:28:01.0 Rescue Therapy [php] [php_1]

Free-Form Entry

CSV