CDE Detailed Report

Disease: Headache
Subdomain Name: Drugs
CRF: Rescue Treatments

Displaying 1 - 15 of 15
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
C16211 Headache pain medication after study drug indicator HdachPainMedctnAftrStdyDrugInd Indicator whether the subject has received any additional pain or headache medications after the study drug was administered Indicator whether the subject has received any additional pain or headache medications after the study drug was administered Did the participant/subject receive any additional pain or headache medication(s) after the study drugs were administered? Yes;No;Unknown Yes;No(STOP);Unknown(STOP) Alphanumeric

If Yes, complete the rescue medication(s) that the particpant/subject received.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Rescue Treatments Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

C18736 Medication prior or concomitant dose unit of measure other text MedctnPriorOrConcomDoseUoMOTH The free-text field related to 'Medication prior or concomitant dose unit of measure', specifying other text. Dosage unit of measure of the prior or concomitant medication administered The free-text field related to 'Medication prior or concomitant dose unit of measure', specifying other text. Dosage unit of measure of the prior or concomitant medication administere Other, specify Alphanumeric Adult;Pediatric Supplemental 2.10 2022-08-02 14:27:44.0 Rescue Treatments Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162730
C18737 Medication prior or concomitant route type other text MedctnPriorOrConcomRteTypOTH The free-text field related to 'Medication prior or concomitant route type', specifying other text. Type of access route for the administration of the prior/concomitant medication The free-text field related to 'Medication prior or concomitant route type', specifying other text. Type of access route for the administration of the prior/concomitant medication Other, specify Alphanumeric Adult;Pediatric Supplemental 2.00 2022-08-02 16:52:05.0 Rescue Treatments Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162743
C22804 Pain present eleven point intensity scale PainPrsnt11IntensityScl Scale for the participant's current pain intensity based on an a scale of 0-10 Scale for the participant's current pain intensity based on an a scale of 0-10 Pain Severity (complete one of the following scales) 0;1;10;2;3;4;5;6;7;8;9 0;1;10;2;3;4;5;6;7;8;9 Numeric Values

Complete one of the following scales

Adult;Pediatric Supplemental 4.00 2023-05-18 16:39:30.0 Rescue Treatments Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

C02006 Medication prior or concomitant dose MedctnPriorOrConcomDose Dose of prior/concomitant medication taken per administration Dose of prior/concomitant medication taken per administration Dose Numeric Values Adult;Pediatric Supplemental 3.10 2022-08-02 14:33:32.0 Rescue Treatments Drugs Treatment/Intervention Data

Free-Form Entry

3162729
C56039 Headache migraine rescue device used name HeadMigRescueDeviceUsedName The name of the rescue device used in the treatment of headache or migraine The name of the rescue device used in the treatment of headache or migrain Device Name Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-05 14:38:04.0 Rescue Treatments Drugs Treatment/Intervention Data 255

Free-Form Entry

C02013 Medication prior or concomitant dose unit of measure UCUM code MedctnPriorOrConDseUOMUCUMCode Code that represents the dosage unit of measure of the prior or concomitant medication administered. Unified Code for Units of Measure (UCUM) Code that represents the dosage unit of measure of the prior or concomitant medication administered. Unified Code for Units of Measure (UCUM) Unit Administered Alphanumeric Adult;Pediatric Supplemental 3.10 2022-08-02 14:42:09.0 Rescue Treatments Drugs Treatment/Intervention Data 255

Free-Form Entry

C56040 Headache migraine rescue device used start date HeadMigRescDevUsedStartDate The start date on which the rescue device was used in the treatment of headache or migraine The start date on which the rescue device was used in the treatment of headache or migrain Start Date Date or Date & Time Adult;Pediatric Supplemental 1.00 2017-06-05 14:41:58.0 Rescue Treatments Drugs Treatment/Intervention Data

Free-Form Entry

C02014 Medication prior or concomitant name MedctnPriorConcomName Name of the prior/concomitant agent or drug administered Name of the prior/concomitant agent or drug administere Medication Name Alphanumeric

Verbatim name (generic or trade name) of the medication, including vitamins and herbal supplements the participant/subject reports taking.;Verbatim name (generic or trade name) of the rescue medication or treatment the participant/subject has received.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Rescue Treatments Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162728
C56041 Headache migraine rescue device used end date HeadMigRescDevUsedEndDate The end date on which the rescue device was used in the treatment of headache or migraine The end date on which the rescue device was used in the treatment of headache or migrain End Date Date or Date & Time Adult;Pediatric Supplemental 1.00 2017-06-05 14:41:58.0 Rescue Treatments Drugs Treatment/Intervention Data

Free-Form Entry

C02015 Medication prior or concomitant route type MedctnPriorOrConcomRteTyp Type of access route for the administration of the prior/concomitant medication Type of access route for the administration of the prior/concomitant medication Route of Administration Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By Ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify Alphanumeric Adult;Pediatric Supplemental 3.10 2022-08-02 14:44:16.0 Rescue Treatments Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162743
C56042 Headache severity scale HeadacheSeverityScale The scale of the amount of headache the participant/subject is experiencing The scale of the amount of headache the participant/subject is experiencin Pain Severity (complete one of the following scales) Mild;Moderate;Severe;None Mild;Moderate;Severe;None Alphanumeric

Complete one of the following scales.

Adult;Pediatric Supplemental 1.00 2017-06-05 14:46:52.0 Rescue Treatments Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

C02016 Medication prior or concomitant start date and time MedctnPriorOrConcmStrtDateTime The date (and time, if applicable and known) on which the prior/concomitant medication usage began The date (and time, if applicable and known) on which the prior/concomitant medication usage began. Time Rescue Drug Adminstered (24 hour clock) Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.10 2022-08-02 16:58:56.0 Rescue Treatments Drugs Treatment/Intervention Data

Free-Form Entry

3162752
C02025 Medication prior or concomitant RXNorm code MedctnPriorConcomRxNormCode Code for name of the prior/concomitant agent or drug administered Code for name of the prior/concomitant agent or drug administere Medication Name Alphanumeric

Code the verbatim name (generic or trade name) of the rescue medication using RXNorm.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Rescue Treatments Drugs Treatment/Intervention Data 255

Free-Form Entry

3162728
C05122 Study therapy administered date and time StdyTherpyAdminstrdDateTime Date (and time, if applicable and known) the study therapy was administered to the participant/subject Date (and time, if applicable and known) the study therapy was administered to the participant/subject Time Study Drug Administered (24 hour clock) Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Rescue Treatments Drugs Treatment/Intervention Data

Free-Form Entry

3160681
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