NIMH Data Archive - Data Dictionary: Data Structure

Adverse Events

6,097 Shared Subjects

Description Adverse Events

Data type Clinical Assessments

Categories

Adverse Events

Date created 01/29/2013

Short name adev01

Most Recent Update 02/14/2024
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Version 01

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Definition

Submission Template

Query	Element Name	Data Type	Size	Required	Description	Value Range	Notes	Aliases
	subjectkey	GUID		Required	The NDAR Global Unique Identifier (GUID) for research subject	NDAR*		candidateguid, guid, pseudo_guid, subject_key
	src_subject_id	String	20	Required	Subject ID how it's defined in lab/project			SUBJECT, bid, catieid, ibisid, patid, pid, randid, record_id, subject_id, subjectid, subjid, subnum
	interview_date	Date		Required	Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY			AESDate, aedt, consented_study, date_interview_ses, date_of_interview_contact, date_taken, eventdate_1, intvdate, sdate, visit_date
	interview_age	Integer		Required	Age in months at the time of the interview/test/sampling/imaging.	0::1440	Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.	age, age_m_consent, candidate_age_in_months, dema1, intvage
	sex	String	20	Required	Sex of subject at birth	M;F; O; NR	M = Male; F = Female; O=Other; NR = Not reported	dema2, gender, sex
Query	ayen	Integer		Recommended	Has the subject had any adverse events during this study?	0;1;-9	0 = No; 1 = Yes; -9 = Did not inquire	ae_at_all, ae_none, aenone, aeyn, anygenae
Query	aelineno	Integer		Recommended	AE line No			ae_code, aeid_1, lineno
	aestdd	Date		Recommended	AE start date MM/DD/YYYY			AES1DATE, ae_dstart, ae_onsd, ae_start_date_1, aef003, aestartdt, aestrtdt, startdateofevent
	aeendd	Date		Recommended	AE end date MM/DD/YYYY			ae_dstop, ae_endd, ae_stop_date_1, aeenddt, dateeventresolved
Query	aeongo	Integer		Recommended	Ongoing	0;1	0 = No; 1 = Yes	aecont, ael_09, aestatus_1, on_going, ongoing
Query	aesev	Integer		Recommended	Severity	1 :: 5;-9;999	1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; 5=Death; -9=Unknown; 999= Missing	AES1SVRT, ae_severity, ae_severity_1, aef004, ael_04, aesa16a, aeseverity, sev, severity, severityoeevent
Query	aerel	Integer		Recommended	Relatedness	1 :: 5;999	1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related; 4= Possibly Related; 5= Probably Related; 999= Missing	ae_caus, ae_relation_1, relation, relationshipofevent
Query	aeexp	Integer		Recommended	Expected	0;1; -9	0 = No; 1 = Yes; -9 =unknown	ae_expected_1, aeexpctd, aef006, eventexpected_1, expected
Query	aeacn	Integer		Recommended	Action taken	1 :: 14;99;999	1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 6= Drug interrupted; 7= Not applicable; 8= Unknown; 9 = Dose increased; 10 = Delayed; 11=Change Administration Time; 12= No Action; 13= Interrupted; 14= Discontinued; 99=Other; 999= Missing	actionwithstudy, ae_action, ae_action_taken_1, ae_actn, aeact
Query	aeout	Integer		Recommended	Outcome	1 :: 20;-9;999	1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; 13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15= recovered/resolving; 16= returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving ; 19 = Worsened; 20= Unresolved; -9=unknown; 999= Missing	ae_outc, ae_outcome, ae_outcome_1, aef009, aeoutcm, aeoutcome, outcome
Query	aeser	Integer		Recommended	Serious	0;1; -9	0 = No; 1 = Yes; -9=unknown	ae_sade, ae_sae, ae_sae_1, ae_serious, aef007, aesae, aeseryn, serious
	comments_misc	String	4,000	Recommended	Miscellaneous comments on study, interview, methodology relevant to this form data			AESINFO, ae_comment, comments, emnetnarrative_1
Query	visit	String	60	Recommended	Visit name			int1, interval, timept, visitn, vtypae
	ae	String	4,000	Recommended	Adverse event Description			AES1, adverse_event, ae_event_1, ae_name, ae_sym, aedesc, aef002a, aeid, ael02sd1, aesa21a, descriptionofevent, event_desc
Query	aes	Integer		Recommended	Have you had any physical or mental health problems since your last visit?	0;1	0 = No; 1 = Yes
	aes2	String	500	Recommended	Description of Adverse Event2			ae_event_2, aesa17, aesa21b
	aes2date	Date		Recommended	Adverse Event2 Onset Date			ae_start_date_2
Query	aes2svrt	Integer		Recommended	Severity of AE 2	1::3	1 = Mild; 2 = Moderate; 3 = Severe	ae_severity_2, aesa17a
Query	aes3	String	500	Recommended	Description of Adverse Event3			ae_event_3, aesa21c
	aes3date	Date		Recommended	Adverse Event3 Onset Date			ae_start_date_3
Query	aes3svrt	Integer		Recommended	Severity of AE 3	0::3	1 = Mild; 2 = Moderate; 3 = Severe; 0=Absent	ae_severity_3, aesa18a
Query	aescode	Integer		Recommended	Staff code number of person completing this form		999= Missing Data	ae_pi_initial_1, ae_pi_initial_7, ae_pi_initial_8, ae_pi_initial_9
Query	aef001	Integer		Recommended	Adverse Event number		-9=unknown	ae_num, aenum
	aef002	String	250	Recommended	Adverse Event term (e.g., headache)			aecode
Query	aef005	Integer		Recommended	Study drug related?	1::9	1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 5=Remotely; 6=Definetley Not; 7= Unknown; 9=Not applicable;8=Medication Rebound	ae_relation, aef005a, aef005b, aerelated, aerelatedrug, relationtomed, stdydrug
Query	aef008	Integer		Recommended	Action taken (If more than one, select other and enter comments below.)	1 :: 11;-9;999	1= None; 2= Stop treatment; 3= Medication; 4= Health care; 5= Hospitalization; 6= Other (specify); 7= Physiotherapy; 8= Hospitalization and medicine; 9= Physiotherapy and medicine; 10= Hospitalization and physio; 11= Hospitalization, medicine, and physio; -9=Unknown; 999= Missing	ae_trmt, treatmentrequired
	aef008a	String	200	Recommended	If other action taken, specify			ae_trmt_other, aeactsp, aef008a1, aef008b1, ael_06cs, otherpleasespecify, whatothr
	aef009a	Date		Recommended	Date of resolution or change in severity (mm/dd/yyyy)			aestopdt
Query	aestrt0	Float		Recommended	Weeks from Time 0 (randomization) to AE onset date			weekssinceenrollment_1
Query	aerest0	Float		Recommended	Weeks from Time 0 (randomization) to AE resolution date
Query	leastsev	Integer		Recommended	Columbia Coded Events: Least severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 5 3 6 2 1	1::7	1 = Suicide attempt; 2 = Preparatory suicide behavior; 3 = Self-injurious behavior - unknown intent; 5 = Self-injurious behavior - no suicidal intent; 6 = Suicidal ideation; 7 = Other, no evidence of deliberate self-injurious behavior
Query	mostsev	Integer		Recommended	Columbia Coded Events: Most severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 5 3 6 2 1	1::7	1 = Suicide attempt; 2 = Preparatory suicide behavior; 3 = Self-injurious behavior - unknown intent; 5 = Self-injurious behavior - no suicidal intent; 6 = Suicidal ideation; 7 = Other, no evidence of deliberate self-injurious behavior
Query	causesdr	Integer		Recommended	Causal relationship with study drug	0::8	0= No; 1 = At least possibly related;2=Dose response; 3=Dechallenge/rechallenge; 4=Timing of onset; 5=Seen in other patients in this trial; 6=Known drug effect; 7=Laboratory data; 8=Other
Query	drugact	Integer		Recommended	Drug action taken due to AE	0;1	0= No; 1 = Yes	ael_06, drugactn_a
Query	sdrugact	Integer		Recommended	Specific drug action taken due to AE	1::12	1 = Dose increased; 2 = Dose reduced; 3 = Temporarily discontinued; 4 = Permanently discontinued; 5 = Unblinded; 6 = Unblinded & dose increased; 7 = Unblinded & dose decrease; 8 = Unblinded & temporarily discontinued; 9= Unblinded & permanently discontinued; 10=None; 11=Delayed Dose; 12= other	acttaken, aedrgact, ael_06a
Query	stage	Integer		Recommended	Study stage	0::5; 51::53; 67; -888; -999	0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD); 51=Treatmentas Usual; 52=Screening Alone; 53=Intervention; 67=Unknown; -888=Not Applicable; -999=Missing;	emnetstudystage_1
Query	othact1	Integer		Recommended	Other action taken due to AE: None	1;0	1 = Yes; 0=No	ae_action__1, aeact1, no_other
Query	othact2	Integer		Recommended	Other action taken due to AE: Non-study drug taken	1;0	1 = Yes; 0=No	aeact2, nonstdyd
Query	othact3	Integer		Recommended	Other action taken due to AE: Medical/surgical therapy	1;0	1 = Yes; 0=No	medsurgt
Query	othact4	Integer		Recommended	Other action taken due to AE: Other	1;0	1 = Yes; 0=No	aef008af, aef008bf, ael_06c, othractn
	pt_name	String	50	Recommended	Preferred Term name (second-lowest level)
Query	aeasap	Integer		Recommended	AE initiated ASAP	0;1	0= No; 1 = Yes	initasap
Query	aedur	Integer		Recommended	AE duration (across all stages) days			aedurday
Query	aehosp	Integer		Recommended	Adverse Event hospitalization status	0::2	0 = No 1 = ER visit / ER overnight 2 = Inpatient admission
Query	aeinten	Integer		Recommended	AE intensity during onset stage	0;1	0 = Moderate 1 = Severe
Query	aepsych	Integer		Recommended	AE was a psychiatric event	0;1	0= No; 1 = Yes
Query	aesuicid	Integer		Recommended	TADS Rating (not based on Columbia Coding):Adverse Event was a suicide related event	0;1	0= No; 1 = Yes
Query	anyharm	Integer		Recommended	TADS Rating (not based on Columbia Coding): Adverse Event was classified as harm to self or others	0;1	0= No; 1 = Yes
Query	causecon	Integer		Recommended	Causal relationship with concomitant treatment	0;1	0= No; 1 = Yes	altmed, withtx
Query	causedis	Integer		Recommended	Causal relationship with disease under study	0;1	0= No; 1 = Yes	altprmds, withdses
Query	causeill	Integer		Recommended	Causal relationship with other illness	0;1	0= No; 1 = Yes
Query	maxinten	Integer		Recommended	Maximum AE intensity (across all stages)	0::2	0 = Moderate; 1 = Severe; 2=Mild	ae_mxin
Query	saeind	Integer		Recommended	Indicator for AE being a Serious Adverse Event	0;1	0= No; 1 = Yes	aeser1, issae_1
Query	othharm	Integer		Recommended	TADS Rating (not based on Columbia Coding):Adverse Event was classified as harm to others	0::3	0 = None 2 = Ideation only 3 = Attempt
Query	selfharm	Integer		Recommended	TADS Rating (not based on Columbia Coding):Adverse Event was classified as harm to self	0::3	0 = None 1 = Non-suicidal 2 = Ideation only 3 = Attempt
Query	aepstpmt	Integer		Recommended	Indicator for AE occurring after premature termination	1	1 = Yes
Query	columbia	Integer		Recommended	Indicator for adverse event went through Columbia coding	0;1	0= No; 1 = Yes
Query	crcid	String	40	Recommended	CRC ID/ROA ID
	level	String	10	Recommended	Treatment level
Query	week	Float		Recommended	Week in level/study		99=week 10-week 14
Query	hand_date	Integer		Recommended	reported date			date, dsmbreportdate_1
Query	update	Integer		Recommended	Updated form	0;1	1= yes; 0= no
Query	certcode	Integer		Recommended	stepbd certification code
Query	aexp	Integer		Recommended	adverse experience	1::31;-4;-5;-6;-7	1=Tremor; 2=Dry mouth; 3=Sedation; 4=Constipation; 5=Diarrhea; 6=Headache; 7=Poor memory; 8=Sexual dysfunction; 9=Increase appetite; 10=Lithium; 11=Valproate; 12=Carbamazepine; 13=CBC; 14=TSH; 15=Sodium; 16=Potassium; 17=Chloride; 18=BUN; 19=Carbonate; 20=Glucose; 21=SGOT; 22=Creatinine; 23=Urine analysis; 24=EKG; 25=Other CMF AE; 26=Other lab result; 27=PI; 28=IOR; 29=OCD; 30=Hallucinations; 31=Delusions; -4=Missing; -5=N/A; -6=Unknown; -7=Refused
Query	onsetrz	Integer		Recommended	onset days since randomization			ae3da
Query	aedrug	Integer		Recommended	drug cause ae	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form	ael_05
Query	ianochng	Integer		Recommended	initial action no change	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	iaincr	Integer		Recommended	initial action increase dose	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	iareduce	Integer		Recommended	initial action reducee dose	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	iastop	Integer		Recommended	initial action stop temp	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	iadisc	Integer		Recommended	initial action discontinued	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	iatx	Integer		Recommended	treatment given	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form	ael_06b
Query	iaoth	Integer		Recommended	other action taken	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	aeres	Integer		Recommended	was ae resolved	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	reslvrz	Integer		Recommended	resolved days since randomization			ae8da, aeresdt
Query	othact	Integer		Recommended	other actions related to resol	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	oanochng	Integer		Recommended	other action no change	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	oaincr	Integer		Recommended	other action increase dose	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	oareduce	Integer		Recommended	other action reduce dose	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	oastop	Integer		Recommended	other action stop temp	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	oadisc	Integer		Recommended	other action discontinued	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	oatx	Integer		Recommended	other treatment given	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	oaoth	Integer		Recommended	other action taken	0;1;-4;-5;-6;-7;-8	0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
Query	site	String	101	Recommended	Site		Study Site	ael_01o, site_id, site_uid, site_x, siteid
Query	completed	Integer		Recommended	Checks if completed	0::3	0=No; 1=Yes; 2=Yes, lost; 3=Unverified	aeformstatus_1, formcomp, frmcomp
Query	aestatuschange_1	Integer		Recommended	Suicide Attempt: Was there a status change?	73::77; -888; -999	73=No; 74=Yes, Ideation to Attempt; 75=Yes, Ideation to Completed Suicide; 76=Yes, attempt to Completed Suicide; 77=Not Applicable to this AE Type; -888=Not Applicable; -999=Missing;
Query	callcenterdatasource_1	Integer		Recommended	Data Source: Call Center/Confirmit	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	crisiscenterdatasource_1	Integer		Recommended	Source of Data: Crisis center	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	deathreportnumber_1	Integer		Recommended	Death report number in AE GUI
	discoveryperiod_1	String	20	Recommended	Wk of follow-up assessment or month of chart review during which AE was discovered/occurred
Query	emnetaetype_1	Integer		Recommended	Type of Adverse Event	39::48; 65;66;72; 78; -888; -999	39=NSSI; 40=Suicide Attempt; 41=Suicide Crisis; 42=Death Clearly not Intentional; 43=Death Unsure if Intentional; 44=Death Probably Intentional; 45=Death Clearly Intentional; 46=Hospitalization; 47=ED; 48=Other Distress Durring Assessment; 65=Other ED visit no documentation available; 66=Other Hospitalization no documentation available; 72=Boys Town Event; 78=Other; -888=Not Applicable; -999=Missing;
Query	emnetisdead_1	Integer		Recommended	Did the Subject Die?	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
	emnetothervalue_1	String	50	Recommended	EMNet AE Type: Other (Text)
Query	emnetother_1	Integer		Recommended	EMNet AE Type: Other	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	noselfharmideationdeath_1	Integer		Recommended	Outcome (no self harm ideation): Death	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	noselfharmideationhospdetox_1	Integer		Recommended	Outcome (no self harm ideation): Hospitalization, Detox	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	noselfharmideationhosppsych_1	Integer		Recommended	Outcome (no self harm ideation): Hospitalization, Psychiatric	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	noselfharmideationhosplmed_1	Integer		Recommended	Outcome (no self harm ideation): Hospitalization, Medical	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	noselfharmideationnohosp_1	Integer		Recommended	Outcome: NO Self-harm ideation/behavior (check all that apply) panel	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
	noselfharmideationothval_1	String	50	Recommended	Outcome (no self harm ideation): Other Text			othsptxt
Query	noselfharmideationoth_1	Integer		Recommended	Outcome (no self harm ideation): Other	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	noselfharmideationunknown_1	Integer		Recommended	Outcome (no self harm ideation): Unknown	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	saenumber_1	Integer		Recommended	SAE Number
Query	selfharmideationcrisiscall_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: Transfer to crisis clinicial by Call Center Staff	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	selfharmideationcrisisedvis_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: ED visit not resulting in hospital admission	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	selfharmideationdeath_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: Death	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	selfharmideationhospdetox_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: Detox Hospitalization	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	selfharmideationhospmed_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: Medical Hospitalization	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	selfharmideationhosppsych_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: Psychiatric Hospitalization	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	selfharmideationnohosp_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: ED visit not resulting in hospital admission ?	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
	selfharmideationothervalue_1	String	50	Recommended	Outcome: Self-harm ideation/behavior: Other value (text)
Query	selfharmideationother_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: Other	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	selfharmideationpolice_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: Police/Ems sent to location	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	selfharmideationtransfer_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: Transfer to crisis clinicial by Call Center Staff	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	selfharmideationunknown_1	Integer		Recommended	Outcome: Self-harm ideation/behavior: Unknown	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	selfharmideation_1	Integer		Recommended	Obsolete	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	severity_1	Integer		Recommended	Overall number of anxiety symptoms	8;9;0;1;2;3;4;5	0 = No symptoms; 1 = 1 symptom; 2 = 2-3 symptoms; 3 = 4-6 symptoms; 4 = 7-10 symptoms; 5 = More than 10 symptoms; 8 = Not applicable; 9 = Does not know
Query	sitedatasource_1	Integer		Recommended	Source of Data: Site	0;1; -888; -999	0=False; 1=True; -888=Not Applicable; -999=Missing;
Query	source_1	Integer		Recommended	Source of Data: REDCap, ConfirmIT, Butler, Baseline Assessment, Vital Statistics		33=RED Cap; 34=Confirm IT; 35=Butler; 70=Baseline Assessment; 71=Vital Statistics; -888=Not Applicable; -999=Missing;
Query	studyrelation_1	Integer		Recommended	Relation of event to study	1::5; 9; -888; -999	1=Definite; 2=Probable; 3=Possible; 4=Unlikely; 5=Unrelated; 9=Unknown; -888=Not Applicable; -999=Missing;	ae_relation_1
	updated_date_1	Date		Recommended	Date of last update to AE record			edit_date
Query	fseqno	Integer		Recommended	Sequence Number	0::999	The FSEQNO variable in the ADJ form has a special interpretation compared to other forms. For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as being '002', and FSEQNO of '3' can be thought of as being '003'. The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third digit relates to the specific adjudicator who completed the adjudication form.
Query	visday	Integer		Recommended	Number of days from study baseline to date of visit			vdaael, visitdat_x
Query	aesa1	Integer		Recommended	Orthostatic Faintness:Have you had any problems with lightheadedness or fainting when you get up from sitting down or lying in bed? (Severe = blacking out)	0;1;2;3
Query	drymthsv	Integer		Recommended	dry mouth severity	0::4;-7	0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused	ae_15, aesa2
Query	constisv	Integer		Recommended	constipation severity	0::4;-7	0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused	ae_18, aesa3
Query	aesa4	Integer		Recommended	Sialorrhea: Have you had any problems with excessive saliva or drooling? (Severe = carries a towel)	0;1;2;3	Absent=0; Mild=1; Moderate=2; Severe=3
Query	aesa5	Integer		Recommended	Menstrual Irregularities (Premenopausal women): Have you had any problems with changes in your menstrual periods? (Severe = menses have ceased)	0::4	Absent=0; Mild=1; Moderate=2; Severe=3; 4=N/A	ae_23
Query	aesa6	Integer		Recommended	Gynecomastia/Galactorrhea: Have you had any problems with swelling or tenderness in your breasts, or discharge from your nipples? (Severe = discharge soils clothes)	0;1;2;3	Absent=0; Mild=1; Moderate=2; Severe=3	ae_24
Query	aesa7	Integer		Recommended	Incontinence/Nocturia: Have you had any problems urinating when you do not plan to during the day, or wetting the bed at night? (Severe = frequently requires changes of clothes or bed-linens)	0;1;2;3	Absent=0; Mild=1; Moderate=2; Severe=3	aesa10a
Query	aesa8	Integer		Recommended	Urinary Hesitancy: Have you had any problems starting to urinate? (Severe = catherization required)	0;1;2;3	Absent=0; Mild=1; Moderate=2; Severe=3	aesa11a
Query	aesa9	Integer		Recommended	Sleepiness: Have you had any problems with drowsiness or sleepiness during the day? (Severe = spontaneously falls asleep during the day.)	0;1;2;3	Absent=0; Mild=1; Moderate=2; Severe=3	aesa13a
Query	aesa10	Integer		Recommended	Hypersomnia: How many hours do you sleep at night? Is this a change from usual for you? Have you had any problems with sleeping too much? (Severe = sleep time increased more than 3 hours most nights )	0;1;2;3	Absent=0; Mild=1; Moderate=2; Severe=3	aesa14a
Query	aesa11	Integer		Recommended	Insomnia: Have you had any problems with falling asleep, staying asleep, or waking up too early? (Severe = sleep time disrupted more than 3 hours most nights).	0;1;2;3	Absent=0; Mild=1; Moderate=2; Severe=3	ae_7, aesa15a
Query	aesa12	Integer		Recommended	Appetite: Have you had any problems with increased appetite? (Severe = constant craving for food).	0;1;2;3	Absent=0; Mild=1; Moderate=2; Severe=3	aesa17ab
Query	aesa13	Integer		Recommended	PARTICIPANT PAIN PERCEPTION Is this Visit 3, Visit 4, or Visit 8 Note: The following pain perception questions are asked of the patients only at Visit 3 (first injection),Visit 4 (wk 1) and Visit 8 (wk8) following the study medication injection. Go to item 15.	0;1	No=0; Yes=1;
Query	aesa14	Float		Recommended	PARTICIPANT PAIN PERCEPTION Note: The following pain perception questions are asked of the patients only at Visit 3 (first injection),Visit 4 (wk 1) and Visit 8 (wk8) following the study medication injection.Record the measurement in millimeters of the patient?s mark above starting from the left hand end of the line to the point that the patient marked, and indicate the value in the space provided.
Query	aesa15	Integer		Recommended	Have you had any other physical or health problems since your last visit? (eg: Has the pt. cut down on normal activities because of not feeling physicallyable since their last visit?) ; go to item 19	0;1	No=0; Yes=1;
Query	version_form	String	121	Recommended	Form used/assessment name			form_id, form_name, vers, vistyp
Query	daysrz	Integer		Recommended	days since randomization			aesa0b, visitdt
Query	aesa7f	Integer		Recommended	Sex Drive: Have you had any problems with your sex drive? (Severe = no interest in sex)	0;1;2;3	0=Absent; 1=Mild; 2=Moderate; 3=Severe
Query	aesa8f	Integer		Recommended	Sexual Arousal: Have you had any problems becoming sexually aroused (Severe (men) = inability to achieve erection; Severe (women) = vaginal dryness)	0;1;2;3	0=Absent; 1=Mild; 2=Moderate; 3=Severe
Query	aesa9f	Integer		Recommended	Sexual Orgasm: Have you any problems having an orgasm? (Severe = anorgasmia)	0;1;2;3	0=Absent; 1=Mild; 2=Moderate; 3=Severe
Query	aesa12f	Integer		Recommended	Skin Rash: Have you had any problems with skin rash or your skin being more sensitive to the sun? (Severe=dermatologic consultation required)	0;1;2;3	0=Absent; 1=Mild; 2=Moderate; 3=Severe	ae_2
Query	aesa16	Integer		Recommended	Weight Gain: Have you had any problems with weight gain? (Severe = new clothes required)	0;1;2;3	0=Absent; 1=Mild; 2=Moderate; 3=Severe
Query	aesa18	Integer		Recommended	Akathisia/activation: Have you had any problems with a sense of inner restlessness, or a feeling that you need tomove? Have you had difficulty sitting or standing still due to this restless feeling? (Severe = individual is unable to maintain any position for more than a few seconds)	0;1;2;3	0=Absent; 1=Mild; 2=Moderate; 3=Severe	ae_6
Query	aesa19	Integer		Recommended	Akinesia: (A decrease in spontaneous motor activity): Have you noticed that you are more slowed down? Does it take you longer to start an activity? to complete an activity? Do you have fewer facial expressions? fewer gestures? fewer body movements? Do you feel listless? Are you less spontaneous? (Severe = decrease in spontaneous moto activity that is clearly noticeable to others and significantly interferes with ability to perform activities of daily living)	0;1;2;3	0=Absent; 1=Mild; 2=Moderate; 3=Severe
Query	aesa20	Integer		Recommended	Nausea: Have you had any problems with nausea? (Severe=unable to eat without vomiting)	0::4	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 4=not done	ae_21, aesa2_a
Query	aesa21a1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question a	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7aii, aesa8_a
Query	aesa21b1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question b	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7bii, aesa9_a
Query	aesa21c1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question c	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7cii, aesa10_a
Query	aesa21d1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question d	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7dii
Query	aesa21d	String	500	Recommended	Description of Adverse Event4			ae_event_4
Query	study	String	100	Recommended	Study; The code for each individual study			studyid
Query	subtrial_name	Integer		Recommended	Name of subtrial	1::3	1=Crossover; 2=Guanfacine; 3= Open Label MPH
Query	aetot	Float		Recommended	Page Total	0::999
Query	aeany	Integer		Recommended	Any AEs	0;1	0=No; 1=Yes	noevent
Query	aeonsdt	Integer		Recommended	When the adverse event started in days from the randomization date (AEONSDT = AE onset date - randomization date)
Query	aeact3	String	3	Recommended	Non-pharmacologic therapy given	3	3=Remedial Therapy-Non Pharmacologic
Query	pmmednum	Integer		Recommended	Medication/treatment number			aemednum
	aerestm	String	5	Recommended	Time of resolution/change in severity		Q12 Time. Valid entries are HH:MM	restime
Query	aedurhr	Float		Recommended	AE Duration Hours	0::24
Query	aedurmin	Float		Recommended	AE Duration Minutes	0::60
	aeonstm	String	30	Recommended	AE onset time			onsettm
	aeterm	String	250	Recommended	Verbatim Term
Query	aechng	Integer		Recommended	Is this an existing AE changing in severity?	1;2	1=Yes; 2=No
Query	aeinit	Integer		Recommended	If Yes , please indicate initial AE number
Query	sibre	Integer		Recommended	Suicidal Ideation and Behavior Reportable Event	1;2	1=Yes; 2=No
Query	aerisk	Integer		Recommended	Places subject or others at risk	1;2	1=Yes; 2=No
Query	aeconmed	Integer		Recommended	Concomitant Medication Given	1;2	1=Yes; 2=No
	sqlatxt	String	250	Recommended	Resolved with Sequelae text
Query	irbrprt	Integer		Recommended	Report to IRB	1;2	1=Yes; 2=Doesn't fit criteria for IRB reporting
	irbrptdt	Date		Recommended	IRB report date
Query	sae	Integer		Recommended	Was this an SAE (severe adverse event)	0;1	0=No; 1=Yes
Query	action	String	1	Recommended	Action taken regarding study treatment	A; B; C;D; E; F; G;U; H	A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown; H=Dose increased
Query	phase_ct	String	20	Recommended	Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase.	Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
Query	reportid	Integer		Recommended	Number of AE Report by Patient		The case report form used to create this file is a ¿multi- copy¿ form, meaning more than one copy of it can be completed at any one visit. For example, a patient with three adverse events to report at a single visit would have 3 copies of the form at that visit, one for each adverse event. The data file will have three unique records for this patient at this visit. COPYID identifies the order in which the forms were completed at a visit.
Query	soc	String	100	Recommended	SOC System Organ Class		Coded variable: MedDRA dictionary, version 4.0: System Organ Class This file contains the MedDRA coded terms for any AEs/side effects that were reported spontaneously by the patient at a visit	ae_meddra
	prf_term	String	100	Recommended	Preferred Term		Coded variable: MedDRA dictionary, version 4.0: Preferred Term This file contains the MedDRA coded terms for any AEs/side effects that were reported spontaneously by the patient at a visit	ae_narrow
Query	te1	Integer		Recommended	TE Phase 1/1A		1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
Query	te2	Integer		Recommended	TE Phase 2		1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
Query	te3	Integer		Recommended	TE Phase 3		1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
Query	teoc	Integer		Recommended	TE Open Choice Phase	1	1= (Yes) if AE is treatment emergent in phase (meaning the AE was reported on/after start date of the phase and within 10 days of ending the phase); missing = otherwise
Query	tebase	Integer		Recommended	TE Within 2 Weeks Post-Baseline	1	1=(Yes) if AE is treatment emergent in phase (meaning the AE was reported on/after study baseline date and within 14 days of study baseline date); missing =otherwise
Query	socgrp1	Integer		Recommended	SOC Subgrp 1: Parkinsonism/EPS TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�PARKINSONISM�, �PARKINSONISM AGGRAVATED�, �COGWHEEL RIGIDITY�, �MASKED FACIES�, �BRADYKINESIA�, �TREMOR�, �EXTRAPYRAMIDAL DISORDER�, �DROOLING�, �GAIT FESTINATING�); missing=otherwise
Query	socgrp2	Integer		Recommended	SOC Subgrp 2: Gait Disturbance TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�GAIT ABNORMAL NOS�, �ATAXIA�); missing= otherwise
Query	socgrp3	Integer		Recommended	SOC Subgrp 3: Sedation TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�SEDATION�, �SOMNOLENCE�, �HYPERSOMNIA�, �LETHARGY�); missing= otherwise
Query	socgrp4	Integer		Recommended	SOC Subgrp 4: Dizziness TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�DIZZINESS AGGRAVATED�, �DIZZINESS POSTURAL�, �DIZZINESS (EXCL VERTIGO)�, �BALANCE IMPAIRED NOS�, �SYNCOPE�); missing= otherwise
Query	socgrp5	Integer		Recommended	SOC Subgrp 5: Headaches TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�HEADACHE�, �HEADACHE NOS�, �HEADACHE AGGRAVATED�, �MIGRAINE NOS�); missing= otherwise
Query	socgrp6	Integer		Recommended	SOC Sg 6: Oth Mtr Dstrb/Dysk TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�AKINESIA�, �DYSKINESIA�, �CHOREA NOS�, �TARDIVE DYSKINESIA�, �AKATHISIA�); missing=otherwise
Query	socgrp7	Integer		Recommended	SOC Subgrp 7: Cog Disturb TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�DEMENTIA OF THE ALZHEIMER�S TYPE NOS�, �COGNITIVE DISORDER NEC�, �DEMENTIA NOS�, �MEMORY IMPAIRMENT�); missing= otherwise
Query	socgrp8	Integer		Recommended	SOC Subgrp 8: Seizures TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�PARTIAL SEIZURES NOS�, �GRAND MAL CONVULSION�, �CONVULSIONS NOS�); missing= otherwise
Query	socgrp9	Integer		Recommended	SOC Sbgp 9: Agitation/Agress TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�AGITATION�, �AGITATION AGGRAVATED�, �AGGRESSION�, �AGGRESSION AGGRAVATED�, �HOSTILITY�, �RESTLESSNESS�); missing= otherwise
Query	socgrp10	Integer		Recommended	SOC Subgrp 10: Psychotic Sx TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�DELUSIONS NOS�, �HALLUCINATIONS AGGRAVATED�, �HALLUCINATION NOS�, �HALLUCINATION, AUDITORY�, �PARANOIA�, �PARANOIA AGGRAVATED�, �PSYCHOTIC DISORDER NOS�, �SUSPICIOUSNESS�, �THINKING ABNORMAL�); missing= otherwise
Query	socgrp11	Integer		Recommended	SOC Sbgp 11: Conf/Mntl Stat Chg TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�CONFUSION�, �CONFUSION AGGRAVATED�, �MENTAL STATUS CHANGES�, �DISORIENTATION�, �DELIRIUM�, �DEPRESSED LEVEL OF CONSCIOUSNESS�, �ENCEPHALOPATHY NOS�, �DISTURBANCE IN ATTENTION�); missing= otherwise
Query	socgrp12	Integer		Recommended	SOC Subgrp 12: Sleep Disturbance TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�INSOMNIA�, �SLEEP DISORDER NOS�, �ABNORMAL SLEEP-RELATED EVENT NOS�, �NIGHTMARE�); missing= otherwise
Query	socgrp13	Integer		Recommended	SOC Subgrp 13: Depression TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�DEPRESSION NOS�, �DEPRESSED MOOD�, �MAJOR DEPRESSIVE DISORDER NOS�, �SUICIDAL IDEATION�); missing =otherwise
Query	socgrp14	Integer		Recommended	SOC Subgrp 14: Anxiety TE in P1	1	1=(Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�ANXIETY AGGRAVATED�, �ANXIETY NEC�, �TENSION�); missing= otherwise
Query	socgrp15	Integer		Recommended	SOC Sbgp 15: Fatigue/Weakness TE in P1	1	1= (Yes) if patient has at least one AE that was treatment emergent in Phase 1 and coded to a preferred term of (�FATIGUE�, �MALAISE�, �WEAKNESS�); missing= otherwise
Query	b1_day	Integer		Recommended	Baseline Day - Phase 1/1A		Number of days from study baseline to first day of the phase Based on visit dates
Query	b2_day	Integer		Recommended	Baseline Day - Phase 2		Number of days from study baseline to first day of the phase Based on visit dates
Query	b3_day	Integer		Recommended	Baseline Day - Phase 3		Number of days from study baseline to first day of the phase Based on visit dates
Query	boc_day	Integer		Recommended	Baseline Visit Day- Open Choice Phase		Number of days from study baseline to start date of phase
Query	e1_day	Integer		Recommended	Day Discontinued from Phase 1/1A		Number of days from study baseline to date of phase discontinuation Based on visit dates
Query	e2_day	Integer		Recommended	Day Discontinued from Phase 2		Number of days from study baseline to date of phase discontinuation Based on visit dates
Query	e3_day	Integer		Recommended	Day Discontinued from Phase 3		Number of days from study baseline to date of phase discontinuation Based on visit dates
Query	end_dy	Integer		Recommended	End Day of AE		Number of days from study baseline to end date of AE	stopdays
Query	eoc_day	Integer		Recommended	Visit Day Discontinued from Open Choice		Number of days from study baseline to end date of phase
Query	start_dy	Integer		Recommended	Start Day of AE		Number of days from study baseline to start date of AE	startdays
	lab020	Date		Recommended	Date of PI/clinician signature			ae_pi_date_1, ae_pi_date_2, ae_pi_date_3, ae_pi_date_4, ae_pi_date_5, ae_pi_date_6, ae_pi_date_7, ae_pi_date_8, ae_pi_date_9, aef011
Query	aefther	Integer		Recommended	Therapist type	0::4	0 = IE (Independent Evaluator); 1 = PT (Pharmacotherapist); 2 = CBT (Cognitive Behavioral Therapist); 3 = MD (Medical Doctor); 4 = PI (Principal Investigator)	sft001
Query	reportpd	Integer		Recommended	Reporting period	1;2	1 = Phase 1; 2 = Phase 2
Query	aefreqnc	Integer		Recommended	Number of such events since last visit	0::97;99	0 = no events since last visit;1 = 1 event since last visit;97 = 97 events since last visit;99 = Continuous event
Query	onsetstg	Integer		Recommended	Onset phase	1;2	1 = Phase I;2 = Phase II
Query	dayonset	Integer		Recommended	Study Day Adverse Event Began			onsetdat_x
Query	dayresolved	Integer		Recommended	Study Day Adverse Event Solved			resdat_x
Query	fdacrit	Integer		Recommended	Met FDA reporting criteria for "Serious"?	0;1	0 = No;1 = Yes
	sdatothr	String	250	Recommended	Description of other study drug action taken			ael_06bs
Query	withdrug	Integer		Recommended	Causal relationship: With study participation?	0::4; -9	0 = No;1 = Possibly;2 = Probably;3 = Definitely related; 4=Remotely; -9=NK
Query	status	String	50	Recommended	Status
Query	aecat	Integer		Recommended	AE Body Systems Category	1::33	1 = Cardiovascular;2 = Chest;3 = Ears / Eyes;4 = Gastrointestinal;5 = Genitourinary;6 = Head;7 = Hematological;8 = Mouth;9 = Musculoskeletal;10 = Nose / Throat;11 = Other;12 = Other Psychological/Behavioral;13 = Skin ; 14 = Congenital, Familial and Genetic Disorders ; 15 = Ear and Labyrinth Disorders ; 16 = Endocrine Disorders ; 17 = Eye Disorders ; 18 = Hepatobiliary Disorders ; 19 = Immune System Disorders ; 20 = Infections and Infestations ; 21 = Injury, Poisoning and Procedural Complications ; 22 = Investigations ; 23 = Metabolism and Nutrition Disorders ; 24 = Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps) ; 25 = Nervous System Disorders ; 26 = Pregnancy, Puerperium and Perinatal Conditions ; 27 = Product Issues ; 28 = Renal and Urinary Disorders ; 29 = Reproductive System and Breast Disorders ; 30 = Respiratory, Thoracic and Mediastinal Disorders ; 31 = Social Circumstances ; 32 = Surgical and Medical Procedures ; 33 = Vascular Disorders
	session_id	String	20	Recommended	session ID/screening ID			end_session, screeningid, session
Query	se_b12	Integer		Recommended	12. Diarrhea, loose bowel movements	0::4; -9	0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown	ae_19, aesa1_a
Query	sefgass16	Integer		Recommended	Gastrointestinal - Vomiting (Severity)	0::3; -9; 9	0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 9 = Not Rated;	ae_22, aesa3_a
Query	sefgass6	Integer		Recommended	Gastrointestinal - Abdominal pain (Severity)	0::4; -9	0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not done	aesa4_a
Query	se_b16	Integer		Recommended	16. Headaches	0::3; -9	0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown	ae_12, aesa5_a
Query	pwc016	Integer		Recommended	Since last visit: Weakness	0::3	0=Not present; 1=Mild; 2=Moderate; 3=Severe	aesa6_a
Query	ham_a_q7	Integer		Recommended	7. General somatic symptoms: Muscular Weakness, stiffness, soreness or real pain, more or less diffusely localized in the muscles, such as jaw ache or neck ache.	0::4	0= Not present; The patient is neither more nor less sore or stiff in the muscles than usual; 1= Mild; The patient seems somewhat more stiff or sore in the muscles than usual; 2= Moderate; The symptoms have the character of pain; 3= Severe; Muscle pain interferes to some extent with the patient's daily work and life; 4=Very severe; Muscle pain is present most of the time and clearly interferes with the patient's daily work and life.	aesa7_a
Query	otr_actn_01	Integer		Recommended	Other Action 1	1::4	1= None; 2= Remedial Therapy�Pharmacologic; 3= Remedial Therapy�Non-pharmacologic; 4= Hospitalization (New or Prolonged)	action1
Query	otr_actn_02	Integer		Recommended	Other Action 2	1::4	1= None; 2= Remedial Therapy�Pharmacologic; 3= Remedial Therapy�Non-pharmacologic; 4= Hospitalization (New or Prolonged)	action2
Query	otr_actn_03	Integer		Recommended	Other Action 3	1::4	1= None; 2= Remedial Therapy�Pharmacologic; 3= Remedial Therapy�Non-pharmacologic; 4= Hospitalization (New or Prolonged)	action3
Query	safte50	Integer		Recommended	Bruising	0::4	0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Done	ae_1
Query	aer016a	Integer		Recommended	Blurred vision	0::4;-9	0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done	ae_4
Query	sft003	Integer		Recommended	Sedation/drowsiness	0::3; -9	0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown	ae_5
Query	sft006	Integer		Recommended	Malaise	0::3; -9	0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown	ae_8
Query	sefcnss30	Integer		Recommended	Central Nervous System - Tremor (Severity)	0::4; -9	0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done
Query	sft015	Integer		Recommended	Dizziness/faintness	0::3; -9	0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown	ae_11
Query	sefoths61	Integer		Recommended	Other - Fever (Severity)	0::3; 9; -9	0=Absent, 1=Mild, 2=Moderate, 3=Severe; 9 = Not Rated; -9 = Unknown	ae_13
Query	sefgens49	Integer		Recommended	Genito Urinary - Enuresis (Severity)	0::3; 9; -9	0=Absent, 1=Mild, 2=Moderate, 3=Severe; 9 = Not Rated; -9 = Unknown	ae_17
Query	ae_3	Integer		Recommended	Urticaria: Hives, itching	0::3	0=Absent, 1=Mild, 2=Moderate, 3=Severe
Query	pwc015	Integer		Recommended	Since last visit: Muscle aches or stiffness	0::3	0=Not present; 1=Mild; 2=Moderate; 3=Severe	ae_9
Query	ae_14	Integer		Recommended	Sore throat	0::3	0=Absent, 1=Mild, 2=Moderate, 3=Severe
Query	ae_16	Integer		Recommended	Hypersalivation	0::3	0=Absent, 1=Mild, 2=Moderate, 3=Severe
Query	ae_20	Integer		Recommended	Anorexia	0::3	0=Absent, 1=Mild, 2=Moderate, 3=Severe
Query	ae1t	Integer		Recommended	Number of Adverse Events rated MILD
Query	ae2t	Integer		Recommended	Number of Adverse Events rated MODERATE
Query	ae3t	Integer		Recommended	Number of Adverse Events rated SEVERE
Query	ae4t	Integer		Recommended	Number of Adverse Events rated Mild, Moderate, or Severe
Query	intrt	Integer		Recommended	Treatment Status Code	0::2	0=Baseline; 1=In Treatment; 2=In Follow-up
Query	trtgrp_p	Integer		Recommended	Treatment Group	1;2	1=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
Query	days_visit1	Integer		Recommended	Days from Visit 1			dav1ae
Query	visnum	Float		Recommended	Numeric Visit Number		-1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; 1000=all visits
Query	trtgroup	String	2	Recommended	Treatment Group	N1;N2;R1;R2;R3	N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
Query	recoverydays	Integer		Recommended	Days from baseline recovered from AE
Query	study_id	Integer		Recommended	Study ID number		46=Acute Phase; 47=Stabilization Phase
Query	adverse_event_code	Integer		Recommended	Event Code (select number from code sheet)	1::126	1 = Concentration; 2 = Asthenia/Lassitude/ Increased Fatigability; 3 = Sleepiness/Sedation; 4 = Failing Memory; 5 = Tension/Unrest; 6 = Increased Sleep; 7 = Decreased Sleep; 8 = Increased Dream Activity; 9 = Emotional Indifference; 10 = Dystonia; 11 = Rigidity; 12 = Hypokinesia/Akinesia; 13 = Hyperkinesia; 14 = Tremor; 15 = Akathisia; 16 = Seizures; 17 = Paraesthesias; 18 = Headache;19 = Accommodation Disturbances; 20 = Increased Salivation; 21 = Reduced Salivation (Dry Mouth); 22 = Nausea/Vomiting; 23 = Diarrhea; 24 = Constipation; 25 = Micturition Disturbances; 26 = Polyuria/Polydipsia; 27 = Orthostatic Dizziness; 28 = Palpitations/Tachycardia; 29 = Increased Tendency to sweat; 30 = Skin -UKU: Rash; 31 = Skin -UKU: Pruritis; 32 = Skin -UKU: Photosensitivity; 33 = Skin -UKU: Increased Pigmentation; 34 = Weight-UKU: Weight Gain; 35 = Weight-UKU: Weight Loss; 36 = Genitourinary-UKU: Menorrhagia; 37 = Genitourinary-UKU: Amenorrhea; 38 = Genitourinary-UKU: Galactorrhea; 39 = Genitourinary-UKU: Breast enlargement; 40 = Genitourinary-UKU: Increased Sexual Desire; 41 = Genitourinary-UKU: Decreased Sexual Desire; 42 = Genitourinary-UKU: Erectile Dysfunction; 43 = Genitourinary-UKU: Ejaculatory Dysfunction;44 = Genitourinary-UKU: Orgastic Dysfunction; 45 = Genitourinary-UKU: Dry Vagina;46 = Psychological/Behavioral: Increased motor activity, including activation and hyperactivity; 47 = Psychological/Behavioral: Decreased motor activity; 48 = Psychological/Behavioral: Slurred speech; 49 = Psychological/Behavioral: Confusion; 50 = Psychological/Behavioral: Significant worsening of anxiety or development of anxiety not present at baseline; 51 = Psychological/Behavioral: Suicide gesture/attempt; 52 = Psychological/Behavioral: Suicide completion; 53 = Psychological/Behavioral: Aggression; 54 = Psychological/Behavioral: Development of hallucinations; 55 = Fever; 56 = Psychiatric hospitalization due to worsening condition; 57 = Death (not due to suicide); 58 = Fall; 59 = Accidental Injury; 60 = Pedal edema/edema; 61 = Ecchymosis; 62 = Dizziness/faintness; 63 = Loss of consciousness; 64 = Bradychardia;65 = Muscle/bone/joint pain/condition; 66 = Hair problems; 67 = Medical or Surgical Procedure; 68 = Chest Pain; 69 = Heart attack; 70 = Development or exacerbation of asthma; 71 = Change in study lab values requiring medical intervention; 72 = NMS; 73 = Allergies, Not Otherwise Specified (elicit specific reaction and code using symptomatology. If no other code is applicable, use this code.); 74 = Other;75=Flu or Upper Respiratory Problems, including Bronchitis; 76=Stomach or abdominal discomfort, including "nervous stomach" and abdominal cramps, but not menstrual cramps; 77=Tiredness/fatigue; 78=Hallucinations; 79=Difficulty falling asleep; 80=Repetitive Behavior or Thoughts; 81=Nasal congestion or Cold; 82=Appetite decrease; 83=Tic movements; 84=Irritability; 85=Anxiety; 86=Emotional Outburst/Mood Lability; 87=Coughing; 88=Disinhibition, including behavioral disinhibition; 89=Epistaxis/nosebleed; 90=Abnormal Lab Result: includes anemia; 91=Painful urination; 92=Depression; 93=Dermatologic problems; 94=Not Otherwise Listed (or Unknown); 95=Enuresis; 96=Hypertension; 97=Oppositional Behavior; 98=Shortness of breath; 99=Fever; 100=Withdrawn/Spacey/"Zombie-like"; 101=Dental problems; 102=Difficulty swallowing; 103=Viral Syndrome, includes infectious diseases; 104=Dyskinesia; 105=Muscle/bone/joint pain/condition; 106=Aggression; 107=Early morning awakening; 108=Interrupted sleep/Other Sleep Problems; 110=Sore throat; 111=Tachycardia; 112=Over-Talkativeness; 113=Eye irritation; 114=Ear ache/Otitis, including ear fluid; 115=Mouth Ulcer; 116=Blurred vision; 117=Tinnitus; 118=Poor hearing; 119=Increased thirst; 120=Hyperacusis: sensory sensitivity or oversensitivity; 121=Over focused; 122=Stammering/Stuttering; verbal dysfluency; 123=Medication Rebound; 124=Restlessness/Agitation, including fidgety; 125=Sore tongue; 126=Genital discomfort
Query	agegroup	Integer		Recommended	Age group	0;1	0=Younger adults (<60); 1=Older adults (?60 years)
Query	tx_code	Integer		Recommended	Treatment code	0::3	0=Olanzapine + Sertraline Placebo; 1=Olanzapine + Sertraline; 2=Olanzapine + Sertraline + Lithium Placebo; 3=Olanzapine + Sertraline + Lithium
Query	typeoffall	Integer		Recommended	Description of fall codes	1::5	1 = Due to dizziness, lightheadedness, loss of consciousness, palpitations; 2 = Physical object is cause of fall (eg. trip over object, slip on ice); 3 = Loss of balance not related to 1 or 2; 4 = Other cause (specify in description); 5 = Patient/informant does not know what happened
Query	severityoffall	Integer		Recommended	Severity of injuries	1::4	1 = No injury (no bruises, etc); 2 = No medical attention (bruises, etc); 3 = Medical attention (soft tissue injury); 4 = Medical attention (fracture and/or hospitalization)
Query	rev_orthofracture	String	50	Recommended	Fractures	Yes;No;NK	NK = Not known	fracture
Query	hosp	Integer		Recommended	Action taken: hospitalization	0;1	0=Not checked; 1=Checked	aef008ac, aef008bc, hospitalization
Query	days_baseline	Integer		Recommended	Days since baseline			falldaysafterbl
	aestdtm	String	25	Recommended	AE Onset date and time
	aespdtm	String	25	Recommended	AE End date and time
	stdate	Date		Recommended	Study Treatment stop date			drugspdt
	drugrsdt	Date		Recommended	Study Drug Restart Date
Query	saedinrd	String	2	Recommended	If study drug was interrupted, is this adverse event the primary reason for study drug interruption?	Y;N
Query	saedispd	String	2	Recommended	If study drug was permanently discontinued, is this adverse event the primary reason for study drug discontinuation?	Y;N; NK; NA
Query	saedimtd	String	2	Recommended	If study drug was dechallenged, did AE diminish/abate?	Y;N;NA
Query	saerapr	String	2	Recommended	If study drug was dechallenged, did the AE reappear after study drug was reintroduced?	Y;N;NA
Query	saea19	String	2	Recommended	Outcome of serious adverse event	A;B;C;D;E;F;U	A=Died; B=Ongoing; C=Recovered; D=Recovered with sequelae;E=Not recovered; F=Recovering; U=Unknown	aeoutc
	ratrel	String	250	Recommended	Rationale for relationship
Query	altproc	Integer		Recommended	Alternate causes of the AE: Study procedure	0;1	0=No;1=Yes	aerelateproc
	stprspec	String	100	Recommended	Alternate causes of the AE: Study procedure specify
Query	altillns	Integer		Recommended	Alternate causes of the AE: Concomitant illness	0;1	0=No;1=Yes
	inilspec	String	100	Recommended	Alternate causes of the AE: Concomitant illness specify			ael05ac1
Query	conspec	String	100	Recommended	Alternate causes of the AE: Concomitant med specify			ael05ac2
	othspec	String	100	Recommended	Alternate causes of the AE: Other known or suspected cause specify			ael05ac3
Query	altothr	Integer		Recommended	Alternate causes of the AE: Other known or suspected	0;1	0=No;1=Yes
Query	altnone	Integer		Recommended	Alternate causes of the AE: None	0;1	0=No;1=Yes
	description_of_sae	String	800	Recommended	Description of SAE:			ael_02cd, aeseriousoth, narsymp
Query	death	Integer		Recommended	Serious Criteria: Death	0;1	0=No; 1= Yes	ae_dead, saedeath
Query	defect	Integer		Recommended	Serious Criteria: Congential anomaly/Birth defect	0;1	0=No; 1= Yes	saeconab
Query	dsabl	Integer		Recommended	Serious Criteria: Persistent or significant disabling	0;1	0=No; 1= Yes	saedis
Query	hsptl	Integer		Recommended	Serious Criteria: Initial or prolonged inpatient hospitalization	0;1	0=No; 1= Yes	saehosp
Query	lfthr	Integer		Recommended	Serious Criteria: Life threatening	0;1	0=No; 1= Yes	saelife
Query	ae_serious_signific	Integer		Recommended	SAE Serious because of Medically Significant	0;1	0 = No; 1 = Yes	saeevent
	darsrz	String	250	Recommended	Days since randomization
Query	ci_enrolled	Integer		Recommended	Participant enrolled	0;1	0=No; 1=Yes	enrolled
Query	dayae	Integer		Recommended	If ASAP involved an AE, enter the AE ONSET DAYS from Baseline
Query	q13_pre	Integer		Recommended	Was this event/problem a pre-existing condition?	1; 2; 3; 4; 5; -7; -8; -9	1 = No; 2 = Yes, worse; 3 = Yes, better; 4 = Yes, same; 5 = Maybe; -7 = Don't know; -8 = Refused to answer; -9 = Does not apply
Query	rpttp	Integer		Recommended	Type of Report	1::4	1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report;
Query	freq_increased	Integer		Recommended	Has the frequency increased	0;1	0=No; 1=Yes
Query	sev_increased	Integer		Recommended	Has the severity increased	0;1	0=No; 1=Yes
Query	corther	Integer		Recommended	Corrective Therapy	0;1	0=No; 1=Yes (If Yes, record details in Concomitant Medication section)
Query	excour	Integer		Recommended	Experience	0::4	0=Intermittent; 1=Persistant; 2=Single occurance;3=Intermittent, infrequently: <10 mins or <2x; 4=intermittent, frequently: >10 mins or >2x;
Query	withdrawn	Integer		Recommended	Was patient withdrawn due to this specific AE?	0;1	0=No; 1=Yes
Query	aesa21e1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question e	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7eii
Query	aesa21f1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question f	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7fii
Query	aesa21g1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question g	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7gii
Query	aesa21h1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question h	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7hii
Query	aesa21i1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question i	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7iii
Query	aesa21j1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question j	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7jii
Query	aesa21k1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question k	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7kii
Query	aesa21l1	Integer		Recommended	Clinician Rating of Severity for Adverse Event in question l	0;1;2;3;8;9	0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed	ael_7lii
Query	ae7ada	Integer		Recommended	Adverse event date in days a
Query	ae7bda	Integer		Recommended	Adverse event date in days b
Query	ae7cda	Integer		Recommended	Adverse event date in days c
Query	ae7dda	Integer		Recommended	Adverse event date in days d
Query	ae7eda	Integer		Recommended	Adverse event date in days e
Query	ae7fda	Integer		Recommended	Adverse event date in days f
Query	ae7gda	Integer		Recommended	Adverse event date in days g
Query	ae7hda	Integer		Recommended	Adverse event date in days h
Query	ae7ida	Integer		Recommended	Adverse event date in days i
Query	ae7jda	Integer		Recommended	Adverse event date in days j
Query	ae7kda	Integer		Recommended	Adverse event date in days k
Query	ae7lda	Integer		Recommended	Adverse event date in days l
Query	saps_ad10	Integer		Recommended	Rater number
Query	rand_num	Integer		Recommended	Randomization Number	0::2
	ae_descrip	String	30	Recommended	Standardized description of event		Based on MOSES
Query	ae_maxm	Float		Recommended	Intensity of Event:Mean Value	1::4	1=Mild;2=Moderate;3=Severe;4=Very Severe. Calculated MEAN value will be in the range 1 - 4
Query	ae_maxa	Integer		Recommended	Intensity of Event:Maximum Value	1::4	1=Mild;2=Moderate;3=Severe;4=Very Severe. Calculated MAX value will be in the range 1 - 4
Query	ae_intermit	String	3	Recommended	Occurance of Event Intermittent?	Y;N	Y=yes; N=no
Query	ae_reld	Float		Recommended	Relation to TrialMedication:Median value	1::5	1=Certain; 2=Probable; 3=Possible; 4=Unrelated; 5=Unassessable
Query	aes5	String	50	Recommended	Description of Adverse Event2		0=right; 1=left; 2=both
	cbcl1_2_text	String	500	Recommended	Describe alcohol use		Touching in patterns (Current)
	sae_38	String	250	Recommended	6.2 Course/duration:
	sped3_11	String	500	Recommended	Other problems?		999=NA/NK/missing
Query	bkgrnd_diag	String	1,020	Recommended	Diagnosis. Provided by parent
	behavobs_mood	String	255	Recommended	Affect Mood
	demo_health_condsp	String	100	Recommended	Physical health conditions: specify
Query	chartreview059	String	500	Recommended	Medical inpatient hospitalizations
Query	scid_event_age7	Integer		Recommended	Age at event 7
Query	scid_event_age8	Integer		Recommended	Age at event 8
Query	scid_event_age6	Integer		Recommended	Age at event 6
Query	scid_event_age5	Integer		Recommended	Age at event 5
Query	scid_event_age4	Integer		Recommended	Age at event 4
Query	scid_event_age2	Integer		Recommended	Age at event 2
Query	scid_event_age1	Integer		Recommended	Age at event 1
Query	scid_event_age3	Integer		Recommended	Age at event 3
	scid_np114	String	100	Recommended	Most upsetting event
	scid_np116	String	100	Recommended	Events past month
Query	scid_event_age9	Integer		Recommended	Age at event 9
Query	bg_curothmeds	String	255	Recommended	If non-psychiatric medications or supplements, list them
	med_nm	String	50	Recommended	Psychiatric medication: name
Query	mtype	Integer		Recommended	Med type	1::4	1=Li; 2=NTP; 3 = Other psychiatric medication, 4 = Non-psychiatric medication
Query	ae_10	Integer		Recommended	AE Submissions
	meddra_comment	String	500	Recommended	MedDRA comments
Query	meddra_hlgt_code	Integer		Recommended	MedDRA code High Level Group Term (HLGT) Subordinate to SOC, superordinate grouping for one or more HLTs		10026753=Manic & bipolar mood disorders & disturbances; 10012221=Deliria (incl confusion); 10042460=Suicidal and self-injurious behaviours NEC
	meddra_hlgt_term	String	250	Recommended	MedDRA code High Level Group Term (HLGT) Subordinate to SOC, superordinate grouping for one or more HLTs
Query	meddra_hlt_code	Integer		Recommended	MedDRA code High Level Term (HLT) Subordinate to HLGT, superordinate grouping for one or more PTs		10027939=Mood alterations with manic symptoms; 10010301=Confusion and disorientation; 10042459=Suicidal and self-injurious behaviour
	meddra_htl_term	String	250	Recommended	MedDRA code High Level Term (HLT) Subordinate to HLGT, superordinate grouping for one or more PTs
Query	meddra_llt_code	Integer		Recommended	MedDRA code Lowest Level Term (LLT) Lowest level of the terminology, related to a single PT as a synonym, lexical variant, or quasis non m (Note All PTs ha e an identical LLT)		10026752=Manic; 10010300=Confusion; 10042458=Suicidal ideation	ae_symid
	meddra_llt_term	String	250	Recommended	MedDRA code Lowest Level Term (LLT) Lowest level of the terminology, related to a single PT as a synonym, lexical variant, or quasis non m (Note All PTs ha e an identical LLT)
Query	meddra_pt_code	Integer		Recommended	MedDRA code Preferred Term (PT) Represents a single medical concept Represents a single medical concept		10026749=Mania; 10010305=Confusional state; 10042458=Suicidal ideation
	meddra_pt_term	String	250	Recommended	MedDRA code Preferred Term (PT) Represents a single medical concept Represents a single medical concept
Query	meddra_soc_code	Integer		Recommended	MedDRA term System Organ Class (SOC) Highest level of the terminology, and representing an anatomical or physiological system, eti l o ogy, or purpose		10037175=Psychiatric disorders	ae_organid
Query	meddra_soc_term	String	250	Recommended	MedDRA term System Organ Class (SOC) Highest level of the terminology, and representing an anatomical or physiological system, eti l o ogy, or purpose
Query	meddra_user_id	Integer		Recommended	MedDRA User ID
Query	meddra_version	Float		Recommended	MedDRA Version
Query	meddra_day	Integer		Recommended	MedDRA Days from coding date to baseline visit date
Query	meddra_status	String	100	Recommended	MedDRA coding status
Query	aer_c	Integer		Recommended	Pattern of Manifestation: Did this happen more than once? All of the time? Part of the time?	1::4	1 = isolated, happened one time only; 2 = intermittent, infrequently: < 10-minutes or < 2x; 3 = intermittent, frequently: > 10-minutes or > 2x; 4 = continuous
Query	aer_f	Integer		Recommended	Possible Contributory Factors: Is this unusual for him/her? Is this something he/she has always had? Had it changed/gotten worse recently? Can you think of anything else that may have caused it?	1::8	1 = part of current psychiatric disorder being treated; 2 = intercurrent illness; 3 = other disorder; 4 = prior history of event; 5 = protocol drug; 6 = other drug/drug interaction; 7 = No contributory factor known; 8 = other
Query	none	Integer		Recommended	Action taken: none	0;1	0=Not checked; 1=Checked	aef008aa, aef008ba
Query	therapyp	Integer		Recommended	Action taken: pharm therapy	0;1	0=Not checked; 1=Checked	aef008ab, aef008bb
Query	yr_treat1_ended	Integer		Recommended	Treatment 1 - Terminated	0;1	0 = No; 1 = Yes	aef008ad, aef008bd
Query	wk6c11a	Integer		Recommended	Treatment by a health care provider in a doctors office or clinic.	1;2; 98; -888; -999	1=Yes; 2=No; 98=Refused; -888=Not Applicable; -999=Missing;	aef008ae, aef008be
Query	any_other_aes_to_report_1	Integer		Recommended	Are there any other AEs to report for this visit?	0;1	0= No; 1= Yes	another_ae, any_other_aes_to_report_2, any_other_aes_to_report_3, any_other_aes_to_report_4, any_other_aes_to_report_5, any_other_aes_to_report_6, any_other_aes_to_report_7, any_other_aes_to_report_8, any_other_aes_to_report_9
	ae_stop_date_2	Date		Recommended	Adverse Event 2 stop Date
Query	ae_relation_2	Integer		Recommended	Adverse Event 2 Study Intervention Relationship	1::5	1= Not related; 2= Unlikely related; 3= Possibly related; 4= Probably related; 5= Definitely related
Query	ae_action_taken_2	Integer		Recommended	Adverse Event 2 action taken regarding study Participation	1::7	1= None; 2= Study intervention modification; 3= Study intervention discontinued; 4= Concomitant medication administered; 5= Subject withdrawn from study; 6= Hospitalization; 7= Other
Query	ae_outcome_2	Integer		Recommended	Adverse Event 2 outcome	1::6	1= Resolved; 2= Recovered with sequelae; 3= Ongoing/Continuing treatment; 4= Condition worsening; 5= Death; 6= Unknown
Query	ae_expected_2	Integer		Recommended	Adverse Event 2 Expected	1;2	1= Yes; 2= No
Query	ae_sae_2	Integer		Recommended	Serious Adverse Event 2	1;2	1= Yes; 2= No
	ae_stop_date_3	Date		Recommended	Adverse Event 3 stop Date
Query	ae_relation_3	Integer		Recommended	Adverse Event 3 Study Intervention Relationship	1::5	1= Not related; 2= Unlikely related; 3= Possibly related; 4= Probably related; 5= Definitely related
Query	ae_action_taken_3	Integer		Recommended	Adverse Event 3 action taken regarding study Participation	1::7	1= None; 2= Study intervention modification; 3= Study intervention discontinued; 4= Concomitant medication administered; 5= Subject withdrawn from study; 6= Hospitalization; 7= Other
Query	ae_outcome_3	Integer		Recommended	Adverse Event 3 outcome	1::6	1= Resolved; 2= Recovered with sequelae; 3= Ongoing/Continuing treatment; 4= Condition worsening; 5= Death; 6= Unknown
Query	ae_expected_3	Integer		Recommended	Adverse Event 3 Expected	1;2	1= Yes; 2= No
Query	ae_sae_3	Integer		Recommended	Serious Adverse Event 3	1;2	1= Yes; 2= No
	ae_start_date_4	Date		Recommended	Adverse Event 4 Start Date
	ae_stop_date_4	Date		Recommended	Adverse Event 4 stop Date
Query	ae_severity_4	Integer		Recommended	Adverse Event 4 Severity	1::3	1= Mild; 2= Moderate; 3= Severe
Query	ae_relation_4	Integer		Recommended	Adverse Event 4 Study Intervention Relationship	1::5	1= Not related; 2= Unlikely related; 3= Possibly related; 4= Probably related; 5= Definitely related
Query	ae_action_taken_4	Integer		Recommended	Adverse Event 4 action taken regarding study Participation	1::7	1= None; 2= Study intervention modification; 3= Study intervention discontinued; 4= Concomitant medication administered; 5= Subject withdrawn from study; 6= Hospitalization; 7= Other
Query	ae_outcome_4	Integer		Recommended	Adverse Event 4 outcome	1::6	1= Resolved; 2= Recovered with sequelae; 3= Ongoing/Continuing treatment; 4= Condition worsening; 5= Death; 6= Unknown
Query	ae_expected_4	Integer		Recommended	Adverse Event 4 Expected	1;2	1= Yes; 2= No
Query	ae_sae_4	Integer		Recommended	Serious Adverse 4 Event	1;2	1= Yes; 2= No
	ae_event_5	String	255	Recommended	Adverse Event 5
	ae_start_date_5	Date		Recommended	Adverse Event 5 Start Date
	ae_stop_date_5	Date		Recommended	Adverse Event 5 stop Date
Query	ae_severity_5	Integer		Recommended	Adverse Event 5 Severity	1::3	1= Mild; 2= Moderate; 3= Severe
Query	ae_relation_5	Integer		Recommended	Adverse Event 5 Study Intervention Relationship	1::5	1= Not related; 2= Unlikely related; 3= Possibly related; 4= Probably related; 5= Definitely related
Query	ae_action_taken_5	Integer		Recommended	Adverse Event 5 action taken regarding study Participation	1::7	1= None; 2= Study intervention modification; 3= Study intervention discontinued; 4= Concomitant medication administered; 5= Subject withdrawn from study; 6= Hospitalization; 7= Other
Query	ae_outcome_5	Integer		Recommended	Adverse Event 5 outcome	1::6	1= Resolved; 2= Recovered with sequelae; 3= Ongoing/Continuing treatment; 4= Condition worsening; 5= Death; 6= Unknown
Query	ae_expected_5	Integer		Recommended	Adverse Event 5 Expected	1;2	1= Yes; 2= No
Query	ae_sae_5	Integer		Recommended	Serious Adverse Event 5	1;2	1= Yes; 2= No
	ae_event_6	String	255	Recommended	Adverse Event 6
	ae_start_date_6	Date		Recommended	Adverse Event 6 Start Date
	ae_stop_date_6	Date		Recommended	Adverse Event 6 stop Date
Query	ae_severity_6	Integer		Recommended	Adverse Event 6 Severity	1::3	1= Mild; 2= Moderate; 3= Severe
Query	ae_relation_6	Integer		Recommended	Adverse Event 6 Study Intervention Relationship	1::5	1= Not related; 2= Unlikely related; 3= Possibly related; 4= Probably related; 5= Definitely related
Query	ae_action_taken_6	Integer		Recommended	Adverse Event 6 action taken regarding study Participation	1::7	1= None; 2= Study intervention modification; 3= Study intervention discontinued; 4= Concomitant medication administered; 5= Subject withdrawn from study; 6= Hospitalization; 7= Other
Query	ae_outcome_6	Integer		Recommended	Adverse Event 6 outcome	1::6	1= Resolved; 2= Recovered with sequelae; 3= Ongoing/Continuing treatment; 4= Condition worsening; 5= Death; 6= Unknown
Query	ae_expected_6	Integer		Recommended	Adverse Event 6 Expected	1;2	1= Yes; 2= No
Query	ae_sae_6	Integer		Recommended	Serious Adverse Event 6	1;2	1= Yes; 2= No
	ae_event_7	String	255	Recommended	Adverse Event 7
	ae_start_date_7	Date		Recommended	Adverse Event 7 Start Date
	ae_stop_date_7	Date		Recommended	Adverse Event 7 stop Date
Query	ae_severity_7	Integer		Recommended	Adverse Event 7 Severity	1::3	1= Mild; 2= Moderate; 3= Severe
Query	ae_relation_7	Integer		Recommended	Adverse Event 7 Study Intervention Relationship	1::5	1= Not related; 2= Unlikely related; 3= Possibly related; 4= Probably related; 5= Definitely related
Query	ae_action_taken_7	Integer		Recommended	Adverse Event 7 action taken regarding study Participation	1::7	1= None; 2= Study intervention modification; 3= Study intervention discontinued; 4= Concomitant medication administered; 5= Subject withdrawn from study; 6= Hospitalization; 7= Other
Query	ae_outcome_7	Integer		Recommended	Adverse Event 7 outcome	1::6	1= Resolved; 2= Recovered with sequelae; 3= Ongoing/Continuing treatment; 4= Condition worsening; 5= Death; 6= Unknown
Query	ae_expected_7	Integer		Recommended	Adverse Event 7 Expected	1;2	1= Yes; 2= No
Query	ae_sae_7	Integer		Recommended	Serious Adverse Event 7	1;2	1= Yes; 2= No
	ae_event_8	String	255	Recommended	Adverse Event 8
	ae_start_date_8	Date		Recommended	Adverse Event 8 Start Date
	ae_stop_date_8	Date		Recommended	Adverse Event 8 stop Date
Query	ae_severity_8	Integer		Recommended	Adverse Event 8 Severity	1::3	1= Mild; 2= Moderate; 3= Severe
Query	ae_relation_8	Integer		Recommended	Adverse Event 8 Study Intervention Relationship	1::5	1= Not related; 2= Unlikely related; 3= Possibly related; 4= Probably related; 5= Definitely related
Query	ae_action_taken_8	Integer		Recommended	Adverse Event 8 action taken regarding study Participation	1::7	1= None; 2= Study intervention modification; 3= Study intervention discontinued; 4= Concomitant medication administered; 5= Subject withdrawn from study; 6= Hospitalization; 7= Other
Query	ae_outcome_8	Integer		Recommended	Adverse Event 8 outcome	1::6	1= Resolved; 2= Recovered with sequelae; 3= Ongoing/Continuing treatment; 4= Condition worsening; 5= Death; 6= Unknown
Query	ae_expected_8	Integer		Recommended	Adverse Event 8 Expected	1;2	1= Yes; 2= No
Query	ae_sae_8	Integer		Recommended	Serious Adverse Event 8	1;2	1= Yes; 2= No
	ae_event_9	String	255	Recommended	Adverse Event 9
	ae_start_date_9	Date		Recommended	Adverse Event 9 Start Date
	ae_stop_date_9	Date		Recommended	Adverse Event 9 stop Date
Query	ae_severity_9	Integer		Recommended	Adverse Event 9 Severity	1::3	1= Mild; 2= Moderate; 3= Severe
Query	ae_relation_9	Integer		Recommended	Adverse Event 9 Study Intervention Relationship	1::5	1= Not related; 2= Unlikely related; 3= Possibly related; 4= Probably related; 5= Definitely related
Query	ae_action_taken_9	Integer		Recommended	Adverse Event 9 action taken regarding study Participation	1::7	1= None; 2= Study intervention modification; 3= Study intervention discontinued; 4= Concomitant medication administered; 5= Subject withdrawn from study; 6= Hospitalization; 7= Other
Query	ae_outcome_9	Integer		Recommended	Adverse Event 9 outcome	1::6	1= Resolved; 2= Recovered with sequelae; 3= Ongoing/Continuing treatment; 4= Condition worsening; 5= Death; 6= Unknown
Query	ae_expected_9	Integer		Recommended	Adverse Event 9 Expected	1;2	1= Yes; 2= No
Query	ae_sae_9	Integer		Recommended	Serious Adverse Event 9	1;2	1= Yes; 2= No
	validity	String	13	Recommended	Validity rating	Yes;No;Questionnable
	ae_flareup	Integer		Recommended	Exacerbation of preexisting condition	1::3	1=Recovered; 2=Recovered with Sequalae; 3=Ongoing
	resp_source	Integer		Recommended	Respondent Source	1::6	1= subject; 2= parent; 3= clinician; 4= teacher; 5= trainer; 6= fidelity reviewer	source
	ae20	Integer		Recommended	Enter level of second change in severity.	1::3	1 = Mild ; 2 = Moderate ; 3 = Severe
	ae21	Integer		Recommended	Was there a third change in severity of the adverse event?	0;1	0 = No; 1 = Yes
	ae22	Date		Recommended	Enter date of the third change in severity.
	ae23	Integer		Recommended	Enter visit number that the third change in severity was observed.
	ae24	Integer		Recommended	Enter level of third change in severity.	1::3	1 = Mild ; 2 = Moderate ; 3 = Severe
	ae25	Integer		Recommended	Was there a fourth change in severity of the adverse event?	0;1	0 = No; 1 = Yes
	ae26	Date		Recommended	Enter date of the fourth change in severity.
	ae27	Integer		Recommended	Enter visit number that the fourth change in severity was observed.
	ae28	Integer		Recommended	Enter level of fourth change in severity.	1::3	1 = Mild ; 2 = Moderate ; 3 = Severe
	ae29	Integer		Recommended	Was there a fifth change in severity of the adverse event?	0;1	0 = No; 1 = Yes
	ae30	Date		Recommended	Enter date of the fifth change in severity.
	ae31	Integer		Recommended	Enter visit number that the fifth change in severity was observed.
	ae32	Integer		Recommended	Enter level of fifth change in severity.	1::3	1 = Mild ; 2 = Moderate ; 3 = Severe
	ae33	Integer		Recommended	Was there a sixth change in severity of the adverse event?	0;1	0 = No; 1 = Yes
	ae13	Integer		Recommended	Was there a change in severity of the adverse event?	0;1	0 = No; 1 = Yes
	ae14	Date		Recommended	Enter date of the first change in severity.
	ae15	Integer		Recommended	Enter visit number that the first change in severity was observed.
	ae16	Integer		Recommended	Enter level of first change in severity.	1::3	1 = Mild ; 2 = Moderate ; 3 = Severe
	ae17	Integer		Recommended	Was there a second change in severity of the adverse event?	0;1	0 = No; 1 = Yes
	ae18	Date		Recommended	Enter date of the second change in severity.
	ae19	Integer		Recommended	Enter visit number that the second change in severity was observed.
	aae01	Integer		Recommended	Level of Adverse Event to report	0::2	0=Adverse Event(AE); 1=Serious Adverse Event(SAE); 2=No Adverse Event or Serious Adverse Event to report
	aae02	Date		Recommended	Date of the Event: (DD/MM/YYYY)
	aae03	String	100	Recommended	Time of the Event: (HH:MM)		AM or PM; 999=Time unknown
	aae04	Integer		Recommended	Notified HMRI Coordination Center in 24 hours of the event?	0;1	0=No; 1=Yes
	aae05	String	250	Recommended	Notified HMRI Coordination Center in 24 hours of the event? If Yes; how?	0;1	0=Phone; 1=Email
	aae06	String	250	Recommended	Description of the Adverse Event or the Serious Adverse Event
	primaryorsecondary	Integer		Recommended	Is this event a primary or secondary event	0;1	0=Primary; 1=Secondary
	aeresolved_age	Float		Recommended	age in months at AE resolution
	ae_age	Float		Recommended	age in months at AE occurrence
	aefollowup_age	Float		Recommended	age in months at AE follow-up
	aereport_age	Float		Recommended	age in months at report of AE
	dsmbrprtdt	Date		Recommended	Date Reported to DSMB
	fdarprt	Integer		Recommended	Was it reported to the FDA?		1=Yes; 2=Does not fit criteria for FDA reporting
	fdarprtdt	Date		Recommended	Date Reported to FDA
	aenci	String	250	Recommended	AE NCI Nomenclature
	ae_lrnddt	Date		Recommended	Date Research Staff First Learned of AE/SAE
	ae_pidt	Date		Recommended	Date PI learned of AE/SAE
	ae_hospdt	Date		Recommended	Date of Hospitalization for AE
	ae_dischdt	Date		Recommended	Date of Hospitalization Discharge for AE
	aerel_part	Integer		Recommended	How related is the hospitalization to study participation?	1::5	1 = Not related; 2 = Unlikely Related; 3=Possibly Related; 4= Probably Related; 5 = Definitely related
	aerel_drug	Integer		Recommended	How related is the hospitalization to the study drug?	1::5	1 = Not related; 2 = Unlikely Related; 3=Possibly Related; 4= Probably Related; 5 = Definitely related
	aeaction	String	250	Recommended	Actions taken/Recommendations
	dsmbrprtcmts	String	280	Recommended	Comments on Reporting AE/SAE to DSMB:
	fdarptcmt	String	280	Recommended	Comments for Reporting AE/SAE to FDA:
	ae_unantic	Integer		Recommended	AE/SAE Unanticipated (must meet all 3: unexpected, related or possibly related to the research, and suggests that the research/study drug places subjects or others at a greater risk of harm than was previously known or recognized)?	0;1	1 = Yes; 0 = No
	immrpt	Integer		Recommended	AE/SAE Requires Expedited Reporting to Independent Medical Monitor (IMM)?	1;2	1 = Yes; 2 = No = Submit at monthly AE report (1st Thursday of Every Month)
	immrptdt	Date		Recommended	Date & Intials of Research Staff who Reported AE/SAE to Independent Medical Monitor
	immcmts	String	280	Recommended	Comments on Reporting AE/SAE to Independent Medical Monitor
	irbrpt	Integer		Recommended	AE/SAE Requires Expedited Reporting to BUMC IRB?	1;2	1 = Yes; 2 = No = Submit at Continuing Review
	irbrprtcmts	String	280	Recommended	Comments on Reporting AE/SAE to BUMC IRB:
	dsmbrpt	Integer		Recommended	AE/SAE Requires Expedited Reporting to DSMB?	1;2	1 = Yes; 2 = No = Submit at Triannual Data Reports (two interim and one full)
	adv_notrelat5_spec	String	2,000	Recommended	If not related to study treatment, is event related to: Other. Specify
	adv_action_desc	String	2,000	Recommended	Action taken with study treatment (Final Drug Product): Describe if applicable
	adv_outcome_othr	String	2,000	Recommended	Describe other outcome
	adv_reporting	Integer		Recommended	Adverse Event Reporting	1::3	1=Adverse Event (AE); 2=Serious Adverse Event (SAE); 3=Unanticipated Problem (UPR)
	adv_notrelate	Integer		Recommended	If not related to study treatment, is event related to:	1::5	1=Not related; 2=Related to other procedure; 3=Other medical condition or illness; 4=Other drug; 5=Other
	adv_notrelat1_spec	String	2,000	Recommended	If not related to study treatment, is event related to: Not related. Specify
	adv_notrelat2_spec	String	2,000	Recommended	If not related to study treatment, is event related to: Related to other procedure. Specify
	adv_notrelat3_spec	String	2,000	Recommended	If not related to study treatment, is event related to: Other medical condition or illness. Specify
	adv_notrelat4_spec	String	2,000	Recommended	If not related to study treatment, is event related to: Other drug. Specify
	drughold	Integer		Recommended	Did this event result in study drug hold?	0;1	0=No; 1=Yes
	drugreduce	Integer		Recommended	Did this event result in a study drug dose reduction?	0;1	0=No; 1=Yes
	eventnum	Integer		Recommended	System assigned event number. Unique within the study.
	tests	String	500	Recommended	Describe relevant tests/laboratory data, including dates and results.
	history	String	500	Recommended	Describe other relevant history, including preexisting medical or psychiatric conditions (e.g. allergies, pregnancy, smoking, alcohol use, hepatic / renal dysfunction, depression etc), if applicable.
	outcomeintervention	Integer		Recommended	Required Intervention to Prevent Permanent Impairment/Damage	0;1	0=No; 1=Yes
	outcomemedicalevent	Integer		Recommended	Important Medical Events as Determined by the Site PI or Designee	0;1	0=No; 1=Yes
	intensity	Integer		Recommended	How INTENSE was receiving the electrical stimulation?	1::7	1 = not at all; 4 = moderately; 7 = extremely
	resolution	Integer		Recommended	Indicate outcome of the event	1::3	1=Continuing; 2=Resolved; 3=Resolved with sequelae
	terminated	Integer		Recommended	Did this event result in study termination?	0;1	0=No; 1=Yes
	ae_hosp	Integer		Recommended	Participant Hospitalized for AE or SAE?	0;1	0 = No; 1 = Yes
	ae_hospcmts	String	4,000	Recommended	Hospitalization Comments
	fallsdays	Integer		Recommended	Falls - how many days in the past week did you experience this symptom?	0::7
	fatigue_v2	Integer		Recommended	Fatigue	0;1;-99	0=No; 1=Yes; -99=NA
	fatiguedays	Integer		Recommended	Fatigue - how many days in the past week did you experience this symptom?	0::7
	dyspnea	Integer		Recommended	Dyspnea/labored breathing	0;1;-99	0=No; 1=Yes; -99=NA
	dyspneadays	Integer		Recommended	Dyspnea/labored breathing - how many days in the past week did you experience this symptom?	0::7
	angina	Integer		Recommended	Angina/chest pains	0;1;-99	0=No; 1=Yes; -99=NA
	anginadays	Integer		Recommended	Angina/chest pains - how many days in the past week did you experience this symptom?	0::7
	blisters	Integer		Recommended	Blisters	0;1;-99	0=No; 1=Yes; -99=NA
	blistersdays	Integer		Recommended	Blisters - how many days in the past week did you experience this symptom?	0::7
	chafing	Integer		Recommended	Chafing	0;1;-99	0=No; 1=Yes; -99=NA
	chafingdays	Integer		Recommended	Chafing - how many days in the past week did you experience this symptom?	0::7
	soreness	Integer		Recommended	Muscle soreness	0;1;-99	0=No; 1=Yes; -99=NA
	sorenessdays	Integer		Recommended	Muscle soreness - how many days in the past week did you experience this symptom?	0::7
	strain	Integer		Recommended	Muscle pull/strain	0;1;-99	0=No; 1=Yes; -99=NA
	straindays	Integer		Recommended	Muscle pull/strain - how many days in the past week did you experience this symptom?	0::7
	joint	Integer		Recommended	Joint pain	0;1;-99	0=No; 1=Yes; -99=NA
	jointdays	Integer		Recommended	Joint pain - how many days in the past week did you experience this symptom?	0::7
	falls	Integer		Recommended	Which of the following have you experienced in the last 12 months? Falls	0;1;-9	0 = No; 1 = Yes; -9 = Refused
	eventname	String	60	Recommended	The event name for which the data was collected
	ae_yesno	Integer		Recommended	Did subject experience any adverse events during the study?	0;1	0= No; 1= Yes
	ae_causality	Integer		Recommended	Adverse Event Causality	1::5;9	1= Definitely; 2= Probably; 3= Possibly; 4= Remotely; 5= Definitely not; 9= Unknown
	ae_action__2	Integer		Recommended	Adverse Event Action Taken: Referred to/seen by Primary Care Physician (PCP)	0;1	0= No; 1= Yes
	ae_action__3	Integer		Recommended	Adverse Event Action Taken: Conmed or therapy	0;1	0= No; 1= Yes
	ae_stopdate_known	Integer		Recommended	Is the Adverse Event stop date known?	0;1	0= No; 1= Yes
	ae_stopdate_unknown	Integer		Recommended	(If ae_stopdate_known = 0) If Adverse Event stop date is unknown, why?	1;2;99	1= Participant did not return; 2= Persisted after study completion; 99= Other, comment in progress note
	event1_ongoing	Integer		Recommended	Event 1: Ongoing at the end of the study?	0;1	0 = No; 1 = Yes
	event2_ongoing	Integer		Recommended	Event 2: Ongoing at the end of the study?	0;1	0 = No; 1 = Yes
	event3_ongoing	Integer		Recommended	Event 3: Ongoing at the end of the study?	0;1	0 = No; 1 = Yes
	saa1	Integer		Recommended	Have you had any physical or health problems during [study time]?	0;1	0 = No; 1 = Yes
	saa2	Integer		Recommended	Have you noticed any changes in your physical appearance during [study time]?	0;1	0 = No; 1 = Yes
	saa3	Integer		Recommended	Have you cut down on things you usually do because of not feeling well physically during [study time]?	0;1	0 = No; 1 = Yes
	aae03a	String	150	Recommended	Notified HMRI Coordination Center in 24 hours of the event? If ''No'' why?
	ae_action_4	Integer		Recommended	Adverse Event 4: Action	1::6	1 = No treatment; 2 = Treatment with medication; 3 = Treatment other; 4 = Hospitalization; 5 = CPR; 6 = Other
	ae_comments_4	String	500	Recommended	Adverse Event 4: Comments
	ae_action_5	Integer		Recommended	Adverse Event 5: Action	1::6	1 = No treatment; 2 = Treatment with medication; 3 = Treatment other; 4 = Hospitalization; 5 = CPR; 6 = Other
	ae_comments_5	String	500	Recommended	Adverse Event 5: Comments
	ae_action_6	Integer		Recommended	Adverse Event 6: Action	1::6	1 = No treatment; 2 = Treatment with medication; 3 = Treatment other; 4 = Hospitalization; 5 = CPR; 6 = Other
	ae_comments_6	String	500	Recommended	Adverse Event 6: Comments
	ae_action_7	Integer		Recommended	Adverse Event 7: Action	1::6	1 = No treatment; 2 = Treatment with medication; 3 = Treatment other; 4 = Hospitalization; 5 = CPR; 6 = Other
	ae_comments_7	String	500	Recommended	Adverse Event 7: Comments
	ae_action_8	Integer		Recommended	Adverse Event 8: Action	1::6	1 = No treatment; 2 = Treatment with medication; 3 = Treatment other; 4 = Hospitalization; 5 = CPR; 6 = Other
	ae_comments_8	String	500	Recommended	Adverse Event 8: Comments
	ae_action_9	Integer		Recommended	Adverse Event 9: Action	1::6	1 = No treatment; 2 = Treatment with medication; 3 = Treatment other; 4 = Hospitalization; 5 = CPR; 6 = Other
	ae_outcome_2_a	Integer		Recommended	Adverse Event 2: Outcome	1::6	1 = Resolved; 2 = Resolving; 3 = Not resolved; 4 = Resolved with sequelae; 5 = Fatal; 6 = Unknown
	ae_outcome_3_a	Integer		Recommended	Adverse Event 3: Outcome	1::6	1 = Resolved; 2 = Resolving; 3 = Not resolved; 4 = Resolved with sequelae; 5 = Fatal; 6 = Unknown
	ae_outcome_4_a	Integer		Recommended	Adverse Event 4: Outcome	1::6	1 = Resolved; 2 = Resolving; 3 = Not resolved; 4 = Resolved with sequelae; 5 = Fatal; 6 = Unknown
	ae_outcome_5_a	Integer		Recommended	Adverse Event 5: Outcome	1::6	1 = Resolved; 2 = Resolving; 3 = Not resolved; 4 = Resolved with sequelae; 5 = Fatal; 6 = Unknown
	ae_outcome_6_a	Integer		Recommended	Adverse Event 6: Outcome	1::6	1 = Resolved; 2 = Resolving; 3 = Not resolved; 4 = Resolved with sequelae; 5 = Fatal; 6 = Unknown
	ae_outcome_7_a	Integer		Recommended	Adverse Event 7: Outcome	1::6	1 = Resolved; 2 = Resolving; 3 = Not resolved; 4 = Resolved with sequelae; 5 = Fatal; 6 = Unknown
	ae_outcome_8_a	Integer		Recommended	Adverse Event 8: Outcome	1::6	1 = Resolved; 2 = Resolving; 3 = Not resolved; 4 = Resolved with sequelae; 5 = Fatal; 6 = Unknown
	ae_outcome_9_a	Integer		Recommended	Adverse Event 9: Outcome	1::6	1 = Resolved; 2 = Resolving; 3 = Not resolved; 4 = Resolved with sequelae; 5 = Fatal; 6 = Unknown
	ae_comments_9	String	500	Recommended	Adverse Event 9: Comments
	ae_action_1	Integer		Recommended	Adverse Event 1: Action	1::6	1 = No treatment; 2 = Treatment with medication; 3 = Treatment other; 4 = Hospitalization; 5 = CPR; 6 = Other
	ae_outcome_1_a	Integer		Recommended	Adverse Event 1: Outcome	1::6	1 = Resolved; 2 = Resolving; 3 = Not resolved; 4 = Resolved with sequelae; 5 = Fatal; 6 = Unknown
	ae_comments_1	String	500	Recommended	Adverse Event 1: Comments
	ae_action_2	Integer		Recommended	Adverse Event 2: Action	1::6	1 = No treatment; 2 = Treatment with medication; 3 = Treatment other; 4 = Hospitalization; 5 = CPR; 6 = Other
	ae_comments_2	String	500	Recommended	Adverse Event 2: Comments
	ae_action_3	Integer		Recommended	Adverse Event 3: Action	1::6	1 = No treatment; 2 = Treatment with medication; 3 = Treatment other; 4 = Hospitalization; 5 = CPR; 6 = Other
	ae_comments_3	String	500	Recommended	Adverse Event 3: Comments
	adev_ch_lastapp	Integer		Recommended	Have you had any changes in your health since the last appointment?	0::2	0 = No; 1 = Yes; 2 = Prefer not to respond
	adev_ch_lastapp_ex	String	500	Recommended	If you have had any changes in your health since the last appointment, please explain.

Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

Element Name: This is the standard element name
Data Type: Which type of data this element is, e.g. String, Float, File location.
Size: If applicable, the character limit of this element
Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
Description: A basic description
Value Range: Which values can appear validly in this element (case sensitive for strings)
Notes: Expanded description or notes on coding of values
Aliases: A list of currently supported Aliases (alternate element names)
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