CDE Detailed Report

Disease: Headache
Subdomain Name: Laboratory Tests and Biospecimens/Biomarkers
CRF: Biospecimens Collection and Processing

Displaying 1 - 50 of 84
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
C56142 Assay lower detection limit value AssayLowrDetectLimVal The value of the lower limit of detection of the assay The value of the lower limit of detection of the assa Lower limit of detection of assay Numeric Values Adult;Pediatric Exploratory 1.00 2017-06-06 13:46:27.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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moles over liters
C15630 Postpartum day week value PstpartmDayWkVal Number of days/weeks the participant/subject has been postpartum Number of days/weeks the participant/subject has been postpartum If Yes, specify number of days weeks the participant subject is postpartum Numeric Values

To be answered for women only

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56091 Postmenopausal last menstruation date PostmenLastMenstrDate The date of the participant's last menstruation if she is postmenopausal The date of the participant's last menstruation if she is postmenopausa If postmenopausal, specify date of last menstruation Date or Date & Time

To be answered for women only

Adult;Pediatric Supplemental 1.00 2017-06-06 11:18:22.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56108 CSF specimen opening pressure value CSFCollOpenPresVal The value of the opening pressure of the CSF specimen collected The value of the opening pressure of the CSF specimen collecte Opening pressure Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 12:08:24.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C55382 Medication prescription type text MedicationPrescriptionTypTxt The free-text field related to type of prescription medication participant/subject The free-text field related to type of prescription medication participant/subjec Name Alphanumeric Adult;Pediatric Supplemental 1.00 2017-05-02 09:31:44.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C56126 Centrifugation substance added before after text CentriSubstncAddedBefAftTxt Text specifying the substance(s) added before or after centrifugation Text specifying the substance(s) added before or after centrifugatio Yes, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 13:26:49.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C01701 Lab specimen collection date and time LabSpecmnCollDateTime Date (and time if applicable and known) when the specimen was collected Date (and time if applicable and known) when the specimen was collected Date and time of specimen collection 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 3.00 2013-07-25 08:54:08.2 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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2004004
C56072 Cigarette smoked past week unit of measure CigSmokePastWkUnitMeasr The unit of measure pertaining to the amount of cigarettes the participant has smoked in the past week The unit of measure pertaining to the amount of cigarettes the participant has smoked in the past wee If yes, specify how many cigarettes were smoked in the past week Individual;Pack;Carton Individual;Pack;Carton Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:41:36.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56143 Intra assay variability value IntraAssayVarVal The value representing intra assay variability The value representing intra assay variability Intra assay variability Numeric Values Adult;Pediatric Exploratory 1.00 2017-06-06 13:49:37.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C15632 Premenarchal indicator PremenarchlInd Whether the participant/subject is currently premenarchal, the period before a female's first menstrual cycle Whether the participant/subject is currently premenarchal, the period before a female's first menstrual cycl Is the participant/subject premenarchal? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Complete for Pediatric-studies ONLY

No references available Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56093 Specimen collected for biomarker indicator SpecCollBiomarkInd The indicator relating to whether the participant had any specimen(s) collected for biomarkers The indicator relating to whether the participant had any specimen(s) collected for biomarker Did the subject/participant have any specimen(s) collected for biomarkers? Yes;No;Unknown Yes;No(STOP);Unknown(STOP) Alphanumeric

If there was no specimen collected for biomarkers or it is unknown that a specimen was collected for biomarkers, discontinue obtaining information from participant/subject.

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 11:30:38.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56109 CSF specimen amount taken value CSFSpecAmtTakenVal The value of the amount of CSF that was collected from the participant/subject The value of the amount of CSF that was collected from the participant/subjec Amount of mL taken Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 12:09:36.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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milliliter
C56043 Headache migraine onset time HeadMigOnsetTime The time that the subject's headache started The time that the subject's headache starte Time at onset of first headache following specimen obtained Date or Date & Time Adult;Pediatric Exploratory 1.00 2017-06-05 14:58:03.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56127 Other processing method performed indicator OthrProcMethPerfrmdInd The indicator relating to whether any other processing methods were performed The indicator relating to whether any other processing methods were performe Were any other processing methods performed? No;Yes, specify;Unknown No;Yes, specify;Unknown Alphanumeric

If yes, specify

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:29:38.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C10821 Food last consumed date and time FoodLstConsmDateTime Date (and time, if applicable and known) the participant/subject last ate food Date (and time, if applicable and known) the participant/subject last ate food Date and time the participant last ate or drank fluids 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 3.00 2013-07-22 16:57:17.79 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C56075 Alcoholic drink consume past week count AlcDrinkConsPastWkCt The number of alcoholic drinks that were consumed within the past week The number of alcoholic drinks that were consumed within the past wee Specify how man alcoholic drinks were consumed in the past week Numeric Values

In units

Adult;Pediatric Supplemental 1.00 2017-06-06 10:44:05.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56144 Inter assay variability value InterAssayVarVal The value representing inter assay variability The value representing inter assay variability Inter assay variability Numeric Values Adult;Pediatric Exploratory 1.00 2017-06-06 13:49:37.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C15977 Headache end date and time HdchEndDateTime The time of the day the headache ended The time of the day the headache ended Time at the end of first headache Date or Date & Time

Date and time

Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56095 CSF time collection storage interval CSFTimeCollStorIntrvl The interval between the time CSF was collected and stored The interval between the time CSF was collected and store CSF Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:33:17.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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minute
C56111 Specimen centrifugation speed value SpecCentrSpeedVal The speed at which the specimen was centrifuged The speed at which the specimen was centrifuge Speed and duration of centrifugation Numeric Values

In G force or speed and name centrifugation

Adult;Pediatric Supplemental 1.00 2017-06-06 12:11:18.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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G force
C56053 Sample obtain with headache indicator SampObtWithHeadacheInd The indicator relating to the sample being obtained while the participant was having a headache The indicator relating to the sample being obtained while the participant was having a headach Was sample obtained while the participant was having a headache? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:07:58.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56128 Other processing method performed text OthrProcMethPerfrmdTxt Text specifying any other processing methods that were performed Text specifying any other processing methods that were performe Yes, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 13:30:51.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C12779 Test assay perform date TestAssyPerfrmDate Date the confirmatory diagnostic test or assay was performed Date the confirmatory diagnostic test or assay was performed Date and time of assay time Date or Date & Time Adult;Pediatric Exploratory 3.00 2013-07-24 21:00:23.88 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56077 Prescription medication dose PrescripMedDose The dose of the participant's prescription medication The dose of the participant's prescription medicatio Dose Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 10:57:43.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56145 Assay result type AssayResltTyp The results obtained from the assay The results obtained from the assa Results of assay Abnormal;Normal;Clinically Significant;Unknown;Other, specify Abnormal;Normal;Clinically Significant;Unknown;Other, specify Alphanumeric

Choose one

Adult;Pediatric Exploratory 1.00 2017-06-06 13:53:40.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C16174 Menopause indicator MenopauseInd Indicates whether participant is currently menopausal Indicates whether participant/subject is currently menopausa Is the participant/subject perimenopausal? Yes;No;Unknown Yes;No;Unknown Alphanumeric

To be answered for women only

Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-06-11 00:00:00.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56096 Drink fluid last date and time DrinkFluidLastDateTIme The date and time the participant last drank fluids The date and time the participant last drank fluids Date and time the participant last ate or drank fluids 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.).

Adult;Pediatric Supplemental 1.00 2017-06-06 11:35:36.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C56113 CSF specimen white blood cell count CSFSpecWBCCt The number of white blood cells (WBCs) counted in the participant's CSF specimen The number of white blood cells (WBCs) counted in the participant's CSF specime WBC cell count Numeric Values

Include units

Adult;Pediatric Supplemental 1.00 2017-06-06 12:18:30.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C56056 Sample collection headache diagnosis text SampCollHeadDiagnosTxt Text describing the headache diagnosis at the time of sample collection Text describing the headache diagnosis at the time of sample collection What was the headache diagnosis at the time of sample collection? Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:14:46.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

C56129 Specimen frozen indicator SpecFroznInd The indicator relating to whether the specimen was frozen The indicator relating to whether the specimen was froze Was the specimen frozen? Yes;No (Skip to next section);Unknown (Skip to next section) Yes;No (Skip to next section);Unknown (Skip to next section) Alphanumeric Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:32:05.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C15604 Headache severity prior sample collection score HeadachSevrPriorSampCollctnScr The score rating of the severity of the participant/subject's last headache prior to sample collection The score rating of the severity of the participant/subject's last headache prior to sample collection Record severity of last headache prior to sample collection on a scale of 0-10 0;1;2;3;4;5;6;7;8;9;10 0 (Least severe);1;2;3;4;5;6;7;8;9;10 (Most severe) Numeric Values

0 = least severe; 10 = most severe

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56079 Prescription medication quantity value PrescripMedQuanVal The value representing the quantity of the participant's prescription medication The value representing the quantity of the participant's prescription medicatio Quantity Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 10:59:40.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56097 Blood time collection storage interval BldTimeCollStorIntrvl The interval between the time blood was collected and stored The interval between the time blood was collected and store Blood Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:33:17.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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minute
C56146 Assay result other text AssayResltOthrTxt The free-text field describing another result from the assay The free-text field describing another result from the assa Other, specify Alphanumeric Adult;Pediatric Exploratory 1.00 2017-06-06 13:55:08.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

C16177 Post-menopausal indicator PostMnpslInd Indicates whether participant is post-menopausal Indicates whether participant/subject is post-menopausal Is the participant/subject currently postmenopausal? Yes;No;Unknown Yes;No;Unknown Alphanumeric

To be answered for women only

Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-06-11 00:00:00.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56114 CSF specimen red blood cell count CSFSpecRBCCt The number of red blood cells (RBCs) counted in the participant's CSF specimen The number of red blood cells (RBCs) counted in the participant's CSF specime RBC cell count Numeric Values

Include units

Adult;Pediatric Supplemental 1.00 2017-06-06 12:18:30.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C56057 Headache ictal indicator HeadacheIctalInd The indicator relating to whether the headache was ictal The indicator relating to whether the headache was icta Was headache ictal? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:16:38.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56130 Original specimen repeated refrozen rethawed indicator OrgnSpecRepeatRefRethInd The indicator relating to whether the original specimen has been repeatedly re-frozen or re-thawed The indicator relating to whether the original specimen has been repeatedly re-frozen or re-thawe Has the original specimen been repeatedly re-frozen or re-thawed? Yes;No (Skip to next section);Unknown (Skip to next section) Yes;No (Skip to next section);Unknown (Skip to next section) Alphanumeric

If repeated samples were done, then questions 6-8 need to be repeated for each cycle.

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:34:09.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C15607 Medication history change indicator MedctnHistChngInd Whether or not the participant/subject had a change in his or her medication around the time of specimen collection Whether or not the participant/subject had a change in his or her medication around the time of specimen collectio Indicate whether any medication changes have recently occurred prior to the sample? Yes;No;Unknown Yes;No;Unknown Alphanumeric

These elements should be captured on other study specific source documents (e.g. Headache Diary, and Prior and Concomitant Medications) and should be pre-populated if initially collected elsewhere to avoud redundant data points.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56080 Over the counter medication supplement name OTCMedSuppName The name of the participant's over-the-counter medication and/or supplements The name of the participant's over-the-counter medication and/or supplement Name Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 11:03:02.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 500

Free-Form Entry

C56098 Sample temperature before centrifugation storage value SampTempBefCentStorVal The temperature of the biomarker sample before centrifugation or storage The temperature of the biomarker sample before centrifugation or storag Temperature before centrifugation or storage (i.e. was the sample collected at room temperature or on ice) Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:38:23.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

degrees Celsius
C56147 Headache free after specimen collection verified duration HeadFreeAftrSpecCollVerDur The duration of time which the participant was verified to be headache-free after specimen collection The duration of time which the participant was verified to be headache-free after specimen collectio State the length of time participant was VERIFIED to be a headache free after specimen collection Date or Date & Time Adult;Pediatric Exploratory 1.00 2017-06-06 13:55:58.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C54753 Specimen collection tube type SpecimenCollectionTubTyp Type of tube used for specimen collection Type of tube used for specimen collectio Specify collection tube Other, specify;Polystyrene tubes;Polypropylene tubes Other, specify;Polystyrene tubes;Polypropylene tubes Alphanumeric

Choose one

Adult;Pediatric Supplemental 1.00 2017-04-11 12:19:20.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56117 CSF specimen total protein value CSFSpecTotProtVal The value representing the total protein found in the participant's CSF specimen The value representing the total protein found in the participant's CSF specime Total Protein Numeric Values

Include units

Adult;Pediatric Supplemental 1.00 2017-06-06 13:15:22.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C56059 Headache 28 day prior sample collection rate Headache28DayPriSampCollRt The rate of the participant's headaches during the 28 days prior to sample collection The rate of the participant's headaches during the 28 days prior to sample collection Record 28-day headache days frequency prior to sample collection No headaches in the past 28 days;<1 day per month in the past 28 days;1-4 days in the past 28 days;5-9 days in the past 28 days;10-14 days in the past 28 days;15 or more days in the past 28 days No headaches in the past 28 days;<1 day per month in the past 28 days;1-4 days in the past 28 days;5-9 days in the past 28 days;10-14 days in the past 28 days;15 or more days in the past 28 days Alphanumeric Adult;Pediatric Core 2.00 2022-02-08 12:33:59.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56131 Frozen aliquot volume value FrozenAliquotVolVal The value representing the volume of the frozen aliquot of the sample The value representing the volume of the frozen aliquot of the sampl Frozen aliquot volume Numeric Values

Record and indicate which unit of measure is being used (mL or ?L).

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:35:56.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C15618 Premenopausal indicator PremenpausInd Whether or not the participant/subject is currently in her premenopausal phase Whether or not the participant/subject is currently in her premenopausal phas Is the participant/subject currently premenopausal? Yes;No;Unknown Yes;No;Unknown Alphanumeric

To be answered for women only

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56081 Over the counter medication supplement dose OTCMedSuppDose The dose of the participant's over-the-counter medication and/or supplements The dose of the participant's over-the-counter medication and/or supplement Dose Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:05:51.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56100 CSF time storage analysis interval CSFTimeStorAnaIntrvl The interval of time between CSF storage and analysis The interval of time between CSF storage and analysi CSF Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:40:22.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

minute
C56148 Headache type text HeadahceTypTxt Text specifying the type of headache the participant/subject had, has, or is having Text specifying the type of headache the participant/subject had, has, or is havin Type of headache, specify Alphanumeric Adult;Pediatric Exploratory 1.00 2017-06-06 13:57:46.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

CSV