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The Filter Cart provides a powerful way to query and access data for which you may be interested.  

A few points related to the filter cart are important to understand with the NDA Query/Filter implementation: 

First, the filter cart is populated asyncronously.  So, when you run a query, it may take a moment to populate but this will happen in the background so you can define other queries during this time.  

When you are adding your first filter, all data associated with your query will be added to the filter cart (whether it be a collection, a concept, a study, a data structure/elment or subjects). Not all data structures or collections will necessarily be displayed.  For example, if you select the NDA imaging structure image03, and further restrict that query to scan_type fMRI, only fMRI images will appear and only the image03 structure will be shown.  To see other data structures, select "Find All Subject Data" which will query all data for those subjects. When a secord or third filter is applied, an AND condition is used.  A subject must exist in all filters.  If the subject does not appear in any one filter, that subjects data will not be included in your filter cart. If that happens, clear your filter cart, and start over.  

It is best to package more data than you need and access those data using other tools, independent of the NDA (e.g. miNDAR snapshot), to limit the data selected.  If you have any questions on data access, are interested in using avaialble web services, or need help accessing data, please contact us for assistance.  

Frequently Asked Questions

Glossary

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NDA provides a single access to de-identified autism research data. For permission to download data, you will need an NDA account with approved access to NDA or a connected repository (AGRE, IAN, or the ATP). For NDA access, you need to be a research investigator sponsored by an NIH recognized institution with federal wide assurance. See Request Access for more information.

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Adverse Events

5,546 Shared Subjects

Adverse Events
Clinical Assessments
Adverse Events
01/29/2013
adev01
07/06/2018
View Change History
01
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, subject_id, subjectid, subjid
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY Required field AESDate, aedt, consented_study, date_interview_ses, date_taken, eventdate_1, intvdate, visit_date
interview_age Integer Required Age in months at the time of the interview/test/sampling/imaging. 0 :: 1260 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_m_consent, candidate_age_in_months, dema1, intvage
sex String 20 Required Sex of the subject M;F M = Male; F = Female 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, aenone, aeyn, anygenae
Query aelineno Integer Recommended AE line No aeid_1, lineno
aestdd Date Recommended AE start date MM/DD/YYYY AES1DATE, ae_start_date_1, aef003, aestartdt, aestrtdt
aeendd Date Recommended AE end date MM/DD/YYYY ae_stop_date_1, aeenddt
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::4; -9
1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; -9=unknown AES1SVRT, ae_severity_1, aef004, ael_04, aesa16a, aeseverity, sev, severity
Query aerel Integer Recommended Relatedness 1::3 1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related ae_relation_1, relation
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::11;99
1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown;9 = Dose increased; 10 = Delayed;11=Change Administration Time ae_action_taken_1, aeact
Query aeout Integer Recommended Outcome
1::18; -9
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; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15= recovered/resolving; 16= returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving ae_outcome_1, aef009, aeoutcm, aeoutcome, outcome
Query aeser Integer Recommended Serious
0;1; -9
0 = No; 1 = Yes; -9=unknown ae_sae_1, aef007, aesae, aeseryn, serious
comments_misc String 4,000 Recommended Miscellaneous comments on study, interview, methodology relevant to this form data AESINFO, comments, emnetnarrative_1
Query visit String 50 Recommended Visit name int1, interval, timept, visitn, vtypae
ae String 250 Recommended Adverse event Description AES1, adverse_event, ae_event_1, aedesc, aef002a, aeid, ael02sd1, aesa21a, 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 50 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 50 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 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 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 aef005a, aef005b, aerelated, aerelatedrug, relationtomed, stdydrug
Query aef008 Integer Recommended Action taken (If more than one, select other and enter comments below.) 1::6; -9 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); -9=unknown
aef008a String 200 Recommended If other action taken, specify aeactsp, aef008a1, aef008b1, ael_06cs, 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 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
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=Updated
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 100 Recommended Form used/assessment name 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 50 Recommended Description of Adverse Event4 ae_event_4
Query study String 100 Recommended 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
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
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::13 1 = Cardiovascular;2 = Chest;3 = Ears / Eyes;4 = Gastrointestinal;5 = Genitourinary;6 = Head;7 = Hematological;8 = Mouth;9 = Musculskeletal;10 = Nose / Throat;11 = Other;12 = Other Psychological/Behavioral;13 = Skin
session_id String 20 Recommended session ID/screening ID screeningid
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 ae_10
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 300 Recommended Description of SAE: ael_02cd, aeseriousoth, narsymp
Query death Integer Recommended Serious Criteria: Death
0;1
0=No; 1= Yes 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 255 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
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
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 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
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)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

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