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Adverse Events

adev

01

Adverse Events

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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*guid
src_subject_idString20RequiredSubject ID how it's defined in lab/projectSUBJECT, bid, catieid, patid, pid, randid, subject_id, subjectid, subjid
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired fieldAESDate, aedt, eventdate_1, intvdate
interview_ageIntegerRequiredAge in months at the time of the interview/test/sampling/imaging.0 :: 1260Age 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.dema1, intvage
genderString20RequiredSex of the subjectM;FM = Male; F = Femaledema2
ayenIntegerRecommendedHas the subject had any adverse events during this study?0;10 = No; 1 = Yesaenone, aeyn, anygenae
aelinenoIntegerRecommendedAE line Noaeid_1, lineno
aestddDateRecommendedAE start date MM/DD/YYYYAES1DATE, aef003, aestrtdt
aeenddDateRecommendedAE end date MM/DD/YYYY
aeongoIntegerRecommendedOngoing0;10 = No; 1 = Yesaecont, ael_09, aestatus_1, on_going, ongoing
aesevIntegerRecommendedSeverity1::4; -91 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; -9=unknownAES1SVRT, aef004, ael_04, aesa16a, aeseverity, sev, severity
aerelIntegerRecommendedRelatedness1::31 = Not related; 2 = Possibly/Probably related; 3 = Definitely relatedrelation
aeexpIntegerRecommendedExpected0;1; -90 = No; 1 = Yes; -9 =unknownaeexpctd, aef006, eventexpected_1, expected
aeacnIntegerRecommendedAction taken1::11;991 = 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 Timeaeact
aeoutIntegerRecommendedOutcome1::17; -91 = 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 baselineaef009, aeoutcm, aeoutcome, outcome
aeserIntegerRecommendedSerious0;1; -90 = No; 1 = Yes; -9=unknownaef007, aesae, aeseryn, serious
comments_miscString4,000RecommendedMiscellaneous comments on study, interview, methodology relevant to this form dataAESINFO, comments, emnetnarrative_1
visitString50RecommendedVisit nameCharacter description of each type of visitint1, interval, timept, visitn, vtypae
aeString250RecommendedAdverse event DescriptionAES1, adverse_event, aedesc, aef002a, aeid, ael02sd1, aesa21a
aesIntegerRecommendedHave you had any physical or mental health problems since your last visit?0;10 = No; 1 = Yes
aes2String50RecommendedDescription of Adverse Event2aesa17, aesa21b
aes2dateDateRecommendedAdverse Event2 Onset Date
aes2svrtIntegerRecommendedSeverity of AE 21::31 = Mild; 2 = Moderate; 3 = Severeaesa17a
aes3String50RecommendedDescription of Adverse Event3aesa21c
aes3dateDateRecommendedAdverse Event3 Onset Date
aes3svrtIntegerRecommendedSeverity of AE 30::31 = Mild; 2 = Moderate; 3 = Severe; 0=Absentaesa18a
aescodeIntegerRecommendedStaff code number of person completing this form
aef001IntegerRecommendedAdverse Event number1::99; -9-9=unknownaenum
aef002String250RecommendedAdverse Event term (e.g., headache)aecode
aef005IntegerRecommendedStudy drug related?1::91=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 5=Remotely; 6=Definetley Not; 7= Unknown; 9=Not applicable;8=Medication Reboundaerelated, relationtomed, stdydrug
aef008IntegerRecommendedAction taken (If more than one, select other and enter comments below.)1::6; -91=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); -9=unknown
aef008aString200RecommendedIf other action taken, specifyaeactsp, ael_06cs, whatothr
aef009aDateRecommendedDate of resolution or change in severity (mm/dd/yyyy)aestopdt
aestrt0FloatRecommendedWeeks from Time 0 (randomization) to AE onset dateweekssinceenrollment_1
aerest0FloatRecommendedWeeks from Time 0 (randomization) to AE resolution date
leastsevIntegerRecommendedColumbia 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 11::71 = 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
mostsevIntegerRecommendedColumbia 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 11::71 = 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
causesdrIntegerRecommendedCausal relationship with study drug0::80= 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
drugactIntegerRecommendedDrug action taken due to AE0;10= No; 1 = Yesael_06, drugactn_a
sdrugactIntegerRecommendedSpecific drug action taken due to AE1::121 = 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= otheracttaken, aedrgact, ael_06a
stageIntegerRecommendedStudy 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
othact1IntegerRecommendedOther action taken due to AE: None1;01 = Yes; 0=Noaeact1, no_other
othact2IntegerRecommendedOther action taken due to AE: Non-study drug taken1;01 = Yes; 0=Noaeact2, nonstdyd
othact3IntegerRecommendedOther action taken due to AE: Medical/surgical therapy1;01 = Yes; 0=Nomedsurgt
othact4IntegerRecommendedOther action taken due to AE: Other1;01 = Yes; 0=Noael_06c, othractn
pt_nameString50RecommendedPreferred Term name (second-lowest level)
aeasapIntegerRecommendedAE initiated ASAP0;10= No; 1 = Yesinitasap
aedurIntegerRecommendedAE duration (across all stages) daysaedurday
aehospIntegerRecommendedAdverse Event hospitalization status0::20 = No 1 = ER visit / ER overnight 2 = Inpatient admission
aeintenIntegerRecommendedAE intensity during onset stage0;10 = Moderate 1 = Severe
aepsychIntegerRecommendedAE was a psychiatric event0;10= No; 1 = Yes
aesuicidIntegerRecommendedTADS Rating (not based on Columbia Coding):Adverse Event was a suicide related event0;10= No; 1 = Yes
anyharmIntegerRecommendedTADS Rating (not based on Columbia Coding): Adverse Event was classified as harm to self or others0;10= No; 1 = Yes
causeconIntegerRecommendedCausal relationship with concomitant treatment0;10= No; 1 = Yesaltmed, withtx
causedisIntegerRecommendedCausal relationship with disease under study0;10= No; 1 = Yesaltprmds, withdses
causeillIntegerRecommendedCausal relationship with other illness0;10= No; 1 = Yes
maxintenIntegerRecommendedMaximum AE intensity (across all stages)0::20 = Moderate; 1 = Severe; 2=Mild
saeindIntegerRecommendedIndicator for AE being a Serious Adverse Event0;10= No; 1 = Yesaeser1, issae_1
othharmIntegerRecommendedTADS Rating (not based on Columbia Coding):Adverse Event was classified as harm to others0::30 = None 2 = Ideation only 3 = Attempt
selfharmIntegerRecommendedTADS Rating (not based on Columbia Coding):Adverse Event was classified as harm to self0::30 = None 1 = Non-suicidal 2 = Ideation only 3 = Attempt
aepstpmtIntegerRecommendedIndicator for AE occurring after premature termination11 = Yes
columbiaIntegerRecommendedIndicator for adverse event went through Columbia coding0;10= No; 1 = Yes
crcidString40RecommendedCRC ID/ROA ID
levelString10RecommendedTreatment level
weekFloatRecommendedWeek in level/study99=week 10-week 14
hand_dateIntegerRecommendedreported datedate, dsmbreportdate_1
updateIntegerRecommendedUpdated form0;11=Updated
certcodeIntegerRecommendedstepbd certification code
aexpIntegerRecommendedadverse experience1::31;-4;-5;-6;-71=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
onsetrzIntegerRecommendedonset days since randomizationae3da
aedrugIntegerRecommendeddrug cause ae0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original formael_05
ianochngIntegerRecommendedinitial action no change0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
iaincrIntegerRecommendedinitial action increase dose0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
iareduceIntegerRecommendedinitial action reducee dose0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
iastopIntegerRecommendedinitial action stop temp0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
iadiscIntegerRecommendedinitial action discontinued0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
iatxIntegerRecommendedtreatment given0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original formael_06b
iaothIntegerRecommendedother action taken0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
aeresIntegerRecommendedwas ae resolved0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
reslvrzIntegerRecommendedresolved days since randomizationae8da, aeresdt
othactIntegerRecommendedother actions related to resol0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
oanochngIntegerRecommendedother action no change0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
oaincrIntegerRecommendedother action increase dose0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
oareduceIntegerRecommendedother action reduce dose0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
oastopIntegerRecommendedother action stop temp0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
oadiscIntegerRecommendedother action discontinued0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
oatxIntegerRecommendedother treatment given0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
oaothIntegerRecommendedother action taken0;1;-4;-5;-6;-7;-80=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
siteString100RecommendedSiteStudy Siteael_01o, site_id, site_uid, site_x, siteid
completedIntegerRecommendedChecks if completed0::20=No; 1=Yes; 2=Yes, lostaeformstatus_1, formcomp, frmcomp
aestatuschange_1IntegerRecommendedSuicide Attempt: Was there a status change?73::77; -888; -99973=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;
callcenterdatasource_1IntegerRecommendedData Source: Call Center/Confirmit0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
crisiscenterdatasource_1IntegerRecommendedSource of Data: Crisis center0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
deathreportnumber_1IntegerRecommendedDeath report number in AE GUI
discoveryperiod_1String20RecommendedWk of follow-up assessment or month of chart review during which AE was discovered/occurred
emnetaetype_1IntegerRecommendedType of Adverse Event39::48; 65;66;72; 78; -888; -99939=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;
emnetisdead_1IntegerRecommendedDid the Subject Die?0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
emnetothervalue_1String50RecommendedEMNet AE Type: Other (Text)
emnetother_1IntegerRecommendedEMNet AE Type: Other0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
noselfharmideationdeath_1IntegerRecommendedOutcome (no self harm ideation): Death0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
noselfharmideationhospdetox_1IntegerRecommendedOutcome (no self harm ideation): Hospitalization, Detox0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
noselfharmideationhosppsych_1IntegerRecommendedOutcome (no self harm ideation): Hospitalization, Psychiatric0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
noselfharmideationhosplmed_1IntegerRecommendedOutcome (no self harm ideation): Hospitalization, Medical0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
noselfharmideationnohosp_1IntegerRecommendedOutcome: NO Self-harm ideation/behavior (check all that apply) panel0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
noselfharmideationothval_1String50RecommendedOutcome (no self harm ideation): Other Textothsptxt
noselfharmideationoth_1IntegerRecommendedOutcome (no self harm ideation): Other0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
noselfharmideationunknown_1IntegerRecommendedOutcome (no self harm ideation): Unknown0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
saenumber_1IntegerRecommendedSAE Number
selfharmideationcrisiscall_1IntegerRecommendedOutcome: Self-harm ideation/behavior: Transfer to crisis clinicial by Call Center Staff0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideationcrisisedvis_1IntegerRecommendedOutcome: Self-harm ideation/behavior: ED visit not resulting in hospital admission0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideationdeath_1IntegerRecommendedOutcome: Self-harm ideation/behavior: Death0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideationhospdetox_1IntegerRecommendedOutcome: Self-harm ideation/behavior: Detox Hospitalization0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideationhospmed_1IntegerRecommendedOutcome: Self-harm ideation/behavior: Medical Hospitalization0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideationhosppsych_1IntegerRecommendedOutcome: Self-harm ideation/behavior: Psychiatric Hospitalization0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideationnohosp_1IntegerRecommendedOutcome: Self-harm ideation/behavior: ED visit not resulting in hospital admission ?0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideationothervalue_1String50RecommendedOutcome: Self-harm ideation/behavior: Other value (text)
selfharmideationother_1IntegerRecommendedOutcome: Self-harm ideation/behavior: Other0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideationpolice_1IntegerRecommendedOutcome: Self-harm ideation/behavior: Police/Ems sent to location0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideationtransfer_1IntegerRecommendedOutcome: Self-harm ideation/behavior: Transfer to crisis clinicial by Call Center Staff0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideationunknown_1IntegerRecommendedOutcome: Self-harm ideation/behavior: Unknown0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
selfharmideation_1IntegerRecommendedObsolete0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
severity_1IntegerRecommendedOverall number of anxiety symptoms8;9;0;1;2;3;4;50 = 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
sitedatasource_1IntegerRecommendedSource of Data: Site0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;
source_1IntegerRecommendedSource of Data: REDCap, ConfirmIT, Butler, Baseline Assessment, Vital Statistics33=RED Cap; 34=Confirm IT; 35=Butler; 70=Baseline Assessment; 71=Vital Statistics; -888=Not Applicable; -999=Missing;
studyrelation_1IntegerRecommendedRelation of event to study1::5; 9; -888; -9991=Definite; 2=Probable; 3=Possible; 4=Unlikely; 5=Unrelated; 9=Unknown; -888=Not Applicable; -999=Missing;
updated_date_1DateRecommendedDate of last update to AE recordedit_date
fseqnoIntegerRecommendedSequence Number0::999The 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.
visdayIntegerRecommendedNumber of days from study baseline to date of visitvdaael, visitdat_x
aesa1IntegerRecommendedOrthostatic 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
drymthsvIntegerRecommendeddry mouth severity0::4;-70=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refusedae_15, aesa2
constisvIntegerRecommendedconstipation severity0::4;-70=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refusedae_18, aesa3
aesa4IntegerRecommendedSialorrhea: Have you had any problems with excessive saliva or drooling? (Severe = carries a towel)0;1;2;3Absent=0; Mild=1; Moderate=2; Severe=3
aesa5IntegerRecommendedMenstrual Irregularities (Premenopausal women): Have you had any problems with changes in your menstrual periods? (Severe = menses have ceased)0::4Absent=0; Mild=1; Moderate=2; Severe=3; 4=N/Aae_23
aesa6IntegerRecommendedGynecomastia/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;3Absent=0; Mild=1; Moderate=2; Severe=3ae_24
aesa7IntegerRecommendedIncontinence/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;3Absent=0; Mild=1; Moderate=2; Severe=3aesa10a
aesa8IntegerRecommendedUrinary Hesitancy: Have you had any problems starting to urinate? (Severe = catherization required)0;1;2;3Absent=0; Mild=1; Moderate=2; Severe=3aesa11a
aesa9IntegerRecommendedSleepiness: Have you had any problems with drowsiness or sleepiness during the day? (Severe = spontaneously falls asleep during the day.)0;1;2;3Absent=0; Mild=1; Moderate=2; Severe=3aesa13a
aesa10IntegerRecommendedHypersomnia: 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;3Absent=0; Mild=1; Moderate=2; Severe=3aesa14a
aesa11IntegerRecommendedInsomnia: 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;3Absent=0; Mild=1; Moderate=2; Severe=3ae_7, aesa15a
aesa12IntegerRecommendedAppetite: Have you had any problems with increased appetite? (Severe = constant craving for food).0;1;2;3Absent=0; Mild=1; Moderate=2; Severe=3aesa17ab
aesa13IntegerRecommendedPARTICIPANT 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;1No=0; Yes=1;
aesa14FloatRecommendedPARTICIPANT 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.
aesa15IntegerRecommendedHave 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 190;1No=0; Yes=1;
version_formString100RecommendedForm usedform_name, vers, vistyp
daysrzIntegerRecommendeddays since randomizationaesa0b, visitdt
aesa7fIntegerRecommendedSex Drive: Have you had any problems with your sex drive? (Severe = no interest in sex)0;1;2;30=Absent; 1=Mild; 2=Moderate; 3=Severe
aesa8fIntegerRecommendedSexual Arousal: Have you had any problems becoming sexually aroused (Severe (men) = inability to achieve erection; Severe (women) = vaginal dryness)0;1;2;30=Absent; 1=Mild; 2=Moderate; 3=Severe
aesa9fIntegerRecommendedSexual Orgasm: Have you any problems having an orgasm? (Severe = anorgasmia)0;1;2;30=Absent; 1=Mild; 2=Moderate; 3=Severe
aesa12fIntegerRecommendedSkin 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;30=Absent; 1=Mild; 2=Moderate; 3=Severeae_2
aesa16IntegerRecommendedWeight Gain: Have you had any problems with weight gain? (Severe = new clothes required)0;1;2;30=Absent; 1=Mild; 2=Moderate; 3=Severe
aesa18IntegerRecommendedAkathisia/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;30=Absent; 1=Mild; 2=Moderate; 3=Severeae_6
aesa19IntegerRecommendedAkinesia: (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;30=Absent; 1=Mild; 2=Moderate; 3=Severe
aesa20IntegerRecommendedNausea: Have you had any problems with nausea? (Severe=unable to eat without vomiting)0::40=Absent; 1=Mild; 2=Moderate; 3=Severe; 4=not doneae_21, aesa2_a
aesa21a1IntegerRecommendedClinician Rating of Severity for Adverse Event in question a0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7aii, aesa8_a
aesa21b1IntegerRecommendedClinician Rating of Severity for Adverse Event in question b0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7bii, aesa9_a
aesa21c1IntegerRecommendedClinician Rating of Severity for Adverse Event in question c0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7cii, aesa10_a
aesa21d1IntegerRecommendedClinician Rating of Severity for Adverse Event in question d0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7dii
aesa21dString50RecommendedDescription of Adverse Event4
studyString100RecommendedStudystudyid
subtrial_nameIntegerRecommendedName of subtrial1::31=Crossover; 2=Guanfacine; 3= Open Label MPH
aetotFloatRecommendedPage Total0::999
aeanyIntegerRecommendedAny AEs0;10=No; 1=Yesnoevent
aeonsdtIntegerRecommendedWhen the adverse event started in days from the randomization date (AEONSDT = AE onset date - randomization date)
aeact3String3RecommendedNon-pharmacologic therapy given33=Remedial Therapy-Non Pharmacologic
pmmednumIntegerRecommendedMedication/treatment numberaemednum
aerestmString5RecommendedTime of resolution/change in severityQ12 Time. Valid entries are HH:MMrestime
aedurhrFloatRecommendedAE Duration Hours0::24
aedurminFloatRecommendedAE Duration Minutes0::60
aeonstmString30RecommendedAE onset timeonsettm
aetermString250RecommendedVerbatim Term
aechngIntegerRecommendedIs this an existing AE changing in severity?1;21=Yes; 2=No
aeinitIntegerRecommendedIf Yes , please indicate initial AE number
sibreIntegerRecommendedSuicidal Ideation and Behavior Reportable Event1;21=Yes; 2=No
aeriskIntegerRecommendedPlaces subject or others at risk1;21=Yes; 2=No
aeconmedIntegerRecommendedConcomitant Medication Given1;21=Yes; 2=No
sqlatxtString250RecommendedResolved with Sequelae text
irbrprtIntegerRecommendedReport to IRB1;21=Yes; 2=Doesn't fit criteria for IRB reporting
irbrptdtDateRecommendedIRB report date
saeIntegerRecommendedWas this an SAE (severe adverse event)0;10=No; 1=Yes
actionString1RecommendedAction taken regarding study treatmentA; B; C;D; E; F; G;U; HA=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown; H=Dose increased
phase_ctString20RecommendedCurrent 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
reportidIntegerRecommendedNumber of AE Report by PatientThe 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.
socString100RecommendedSOC System Organ ClassCoded 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_termString100RecommendedPreferred TermCoded 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
te1IntegerRecommendedTE Phase 1/1A1= 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
te2IntegerRecommendedTE Phase 21= 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
te3IntegerRecommendedTE Phase 31= 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
teocIntegerRecommendedTE Open Choice Phase11= (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
tebaseIntegerRecommendedTE Within 2 Weeks Post-Baseline11=(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
socgrp1IntegerRecommendedSOC Subgrp 1: Parkinsonism/EPS TE in P111=(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
socgrp2IntegerRecommendedSOC Subgrp 2: Gait Disturbance TE in P111=(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
socgrp3IntegerRecommendedSOC Subgrp 3: Sedation TE in P111=(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
socgrp4IntegerRecommendedSOC Subgrp 4: Dizziness TE in P111=(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
socgrp5IntegerRecommendedSOC Subgrp 5: Headaches TE in P111=(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
socgrp6IntegerRecommendedSOC Sg 6: Oth Mtr Dstrb/Dysk TE in P111=(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
socgrp7IntegerRecommendedSOC Subgrp 7: Cog Disturb TE in P111=(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
socgrp8IntegerRecommendedSOC Subgrp 8: Seizures TE in P111=(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
socgrp9IntegerRecommendedSOC Sbgp 9: Agitation/Agress TE in P111=(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
socgrp10IntegerRecommendedSOC Subgrp 10: Psychotic Sx TE in P111=(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
socgrp11IntegerRecommendedSOC Sbgp 11: Conf/Mntl Stat Chg TE in P111=(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
socgrp12IntegerRecommendedSOC Subgrp 12: Sleep Disturbance TE in P111=(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
socgrp13IntegerRecommendedSOC Subgrp 13: Depression TE in P111=(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
socgrp14IntegerRecommendedSOC Subgrp 14: Anxiety TE in P111=(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
socgrp15IntegerRecommendedSOC Sbgp 15: Fatigue/Weakness TE in P111= (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
b1_dayIntegerRecommendedBaseline Day - Phase 1/1ANumber of days from study baseline to first day of the phase Based on visit dates
b2_dayIntegerRecommendedBaseline Day - Phase 2Number of days from study baseline to first day of the phase Based on visit dates
b3_dayIntegerRecommendedBaseline Day - Phase 3Number of days from study baseline to first day of the phase Based on visit dates
boc_dayIntegerRecommendedBaseline Visit Day- Open Choice PhaseNumber of days from study baseline to start date of phase
e1_dayIntegerRecommendedDay Discontinued from Phase 1/1ANumber of days from study baseline to date of phase discontinuation Based on visit dates
e2_dayIntegerRecommendedDay Discontinued from Phase 2Number of days from study baseline to date of phase discontinuation Based on visit dates
e3_dayIntegerRecommendedDay Discontinued from Phase 3Number of days from study baseline to date of phase discontinuation Based on visit dates
end_dyIntegerRecommendedEnd Day of AENumber of days from study baseline to end date of AEstopdays
eoc_dayIntegerRecommendedVisit Day Discontinued from Open ChoiceNumber of days from study baseline to end date of phase
start_dyIntegerRecommendedStart Day of AENumber of days from study baseline to start date of AEstartdays
lab020DateRecommendedDate of PI/clinician signatureaef011
aeftherIntegerRecommendedTherapist type0::40 = IE (Independent Evaluator); 1 = PT (Pharmacotherapist); 2 = CBT (Cognitive Behavioral Therapist); 3 = MD (Medical Doctor); 4 = PI (Principal Investigator)sft001
reportpdIntegerRecommendedReporting period1;21 = Phase 1; 2 = Phase 2
aefreqncIntegerRecommendedNumber of such events since last visit0::97;990 = no events since last visit;1 = 1 event since last visit;97 = 97 events since last visit;99 = Continuous event
onsetstgIntegerRecommendedOnset phase1;21 = Phase I;2 = Phase II
dayonsetIntegerRecommendedStudy Day Adverse Event Beganonsetdat_x
dayresolvedIntegerRecommendedStudy Day Adverse Event Solvedresdat_x
fdacritIntegerRecommendedMet FDA reporting criteria for "Serious"?0;10 = No;1 = Yes
sdatothrString250RecommendedDescription of other study drug action takenael_06bs
withdrugIntegerRecommendedCausal relationship: With study participation?0::4; -90 = No;1 = Possibly;2 = Probably;3 = Definitely related; 4=Remotely; -9=NK
statusString50RecommendedStatus
aecatIntegerRecommendedAE Body Systems Category1::131 = 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_idString20Recommendedsession ID/screening IDscreeningid
se_b12IntegerRecommended12. Diarrhea, loose bowel movements0::4; -90=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknownae_19, aesa1_a
sefgass16IntegerRecommendedGastrointestinal - Vomiting (Severity)0::3; -90=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknownae_22, aesa3_a
sefgass6IntegerRecommendedGastrointestinal - Abdominal pain (Severity)0::4; -90=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not doneaesa4_a
se_b16IntegerRecommended16. Headaches0::3; -90=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknownae_12, aesa5_a
pwc016IntegerRecommendedSince last visit: Weakness0::30=Not present; 1=Mild; 2=Moderate; 3=Severeaesa6_a
ham_a_q7IntegerRecommended7. 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::40= 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
otr_actn_01IntegerRecommendedOther Action 11::41= None; 2= Remedial Therapy�Pharmacologic; 3= Remedial Therapy�Non-pharmacologic; 4= Hospitalization (New or Prolonged)action1
otr_actn_02IntegerRecommendedOther Action 21::41= None; 2= Remedial Therapy�Pharmacologic; 3= Remedial Therapy�Non-pharmacologic; 4= Hospitalization (New or Prolonged)action2
otr_actn_03IntegerRecommendedOther Action 31::41= None; 2= Remedial Therapy�Pharmacologic; 3= Remedial Therapy�Non-pharmacologic; 4= Hospitalization (New or Prolonged)action3
safte50IntegerRecommendedBruising0::40=None; 1=Mild; 2=Moderate; 3=Severe; 4=Not Doneae_1
aer016aIntegerRecommendedBlurred vision0::4;-90=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not doneae_4
sft003IntegerRecommendedSedation/drowsiness0::3; -90=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknownae_5
sft006IntegerRecommendedMalaise0::3; -90=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknownae_8
sefcnss30IntegerRecommendedCentral Nervous System - Tremor (Severity)0::4; -90=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not doneae_10
sft015IntegerRecommendedDizziness/faintness0::3; -90=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknownae_11
sefoths61IntegerRecommendedOther - Fever (Severity)0::30=Absent, 1=Mild, 2=Moderate, 3=Severeae_13
sefgens49IntegerRecommendedGenito Urinary - Enuresis (Severity)0::30=Absent, 1=Mild, 2=Moderate, 3=Severeae_17
ae_3IntegerRecommendedUrticaria: Hives, itching0::30=Absent, 1=Mild, 2=Moderate, 3=Severe
pwc015IntegerRecommendedSince last visit: Muscle aches or stiffness0::30=Not present; 1=Mild; 2=Moderate; 3=Severeae_9
ae_14IntegerRecommendedSore throat0::30=Absent, 1=Mild, 2=Moderate, 3=Severe
ae_16IntegerRecommendedHypersalivation0::30=Absent, 1=Mild, 2=Moderate, 3=Severe
ae_20IntegerRecommendedAnorexia0::30=Absent, 1=Mild, 2=Moderate, 3=Severe
ae1tIntegerRecommendedNumber of Adverse Events rated MILD
ae2tIntegerRecommendedNumber of Adverse Events rated MODERATE
ae3tIntegerRecommendedNumber of Adverse Events rated SEVERE
ae4tIntegerRecommendedNumber of Adverse Events rated Mild, Moderate, or Severe
intrtIntegerRecommendedTreatment Status Code0::20=Baseline; 1=In Treatment; 2=In Follow-up
trtgrp_pIntegerRecommendedTreatment Group1;21=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
days_visit1IntegerRecommendedDays from Visit 1dav1ae
visnumFloatRecommendedNumeric 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
trtgroupString2RecommendedTreatment GroupN1;N2;R1;R2;R3N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
recoverydaysIntegerRecommendedDays from baseline recovered from AE
study_idIntegerRecommendedStudy ID number46=Acute Phase; 47=Stabilization Phase
adverse_event_codeIntegerRecommendedEvent Code (select number from code sheet)1::1261 = 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
agegroupIntegerRecommendedAge group0;10=Younger adults (<60); 1=Older adults (?60 years)
tx_codeIntegerRecommendedTreatment code0::30=Olanzapine + Sertraline Placebo; 1=Olanzapine + Sertraline; 2=Olanzapine + Sertraline + Lithium Placebo; 3=Olanzapine + Sertraline + Lithium
typeoffallIntegerRecommendedDescription of fall codes1::51 = 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
severityoffallIntegerRecommendedSeverity of injuries1::41 = No injury (no bruises, etc); 2 = No medical attention (bruises, etc); 3 = Medical attention (soft tissue injury); 4 = Medical attention (fracture and/or hospitalization)
rev_orthofractureString50RecommendedFractures
Yes;No;NK
NK = Not knownfracture
hospIntegerRecommendedAction taken: hospitalization0;10=Not checked; 1=Checkedhospitalization
days_baselineIntegerRecommendedDays since baselinefalldaysafterbl
aestdtmString25RecommendedAE Onset date and time
aespdtmString25RecommendedAE End date and time
stdateDateRecommendedStudy Treatment stop datedrugspdt
drugrsdtDateRecommendedStudy Drug Restart Date
saedinrdString2RecommendedIf study drug was interrupted, is this adverse event the primary reason for study drug interruption?Y;N
saedispdString2RecommendedIf study drug was permanently discontinued, is this adverse event the primary reason for study drug discontinuation?Y;N
saedimtdString2RecommendedIf study drug was dechallenged, did AE diminish/abate?Y;N;NA
saeraprString2RecommendedIf study drug was dechallenged, did the AE reappear after study drug was reintroduced?Y;N;NA
saea19String2RecommendedOutcome of serious adverse eventA;B;C;D;E;F;UA=Died; B=Ongoing; C=Recovered; D=Recovered with sequelae;E=Not recovered; F=Recovering; U=Unknownaeoutc
ratrelString100RecommendedRationale for relationship
altprocIntegerRecommendedAlternate causes of the AE: Study procedure0;10=No;1=Yes
stprspecString100RecommendedAlternate causes of the AE: Study procedure specify
altillnsIntegerRecommendedAlternate causes of the AE: Concomitant illness0;10=No;1=Yes
inilspecString100RecommendedAlternate causes of the AE: Concomitant illness specifyael05ac1
conspecString100RecommendedAlternate causes of the AE: Concomitant med specifyael05ac2
othspecString100RecommendedAlternate causes of the AE: Other known or suspected cause specifyael05ac3
altothrIntegerRecommendedAlternate causes of the AE: Other known or suspected0;10=No;1=Yes
altnoneIntegerRecommendedAlternate causes of the AE: None0;10=No;1=Yes
description_of_saeString300RecommendedDescription of SAE:ael_02cd, narsymp
deathIntegerRecommendedSerious Criteria: Death0;10=No; 1= Yessaedeath
defectIntegerRecommendedSerious Criteria: Congential anomaly/Birth defect0;10=No; 1= Yessaeconab
dsablIntegerRecommendedSerious Criteria: Persistent or significant disabling0;10=No; 1= Yessaedis
hsptlIntegerRecommendedSerious Criteria: Initial or prolonged inpatient hospitalization0;10=No; 1= Yessaehosp
lfthrIntegerRecommendedSerious Criteria: Life threatening0;10=No; 1= Yessaelife
ae_serious_significIntegerRecommendedSAE Serious because of Medically Significantsaeevent
darsrzString250RecommendedDays since randomization
ci_enrolledIntegerRecommendedParticipant enrolled0;10=No; 1=Yesenrolled
dayaeIntegerRecommendedIf ASAP involved an AE, enter the AE ONSET DAYS from Baseline
q13_preIntegerRecommendedWas this event/problem a pre-existing condition?1; 2; 3; 4; 5; -7; -8; -91 = No; 2 = Yes, worse; 3 = Yes, better; 4 = Yes, same; 5 = Maybe; -7 = Don't know; -8 = Refused to answer; -9 = Does not apply
rpttpIntegerRecommendedType of Report1::41=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report;
freq_increasedIntegerRecommendedHas the frequency increased0;10=No; 1=Yes
sev_increasedIntegerRecommendedHas the severity increased0;10=No; 1=Yes
cortherIntegerRecommendedCorrective Therapy0;10=No; 1=Yes (If Yes, record details in Concomitant Medication section)
excourIntegerRecommendedExperience0::40=Intermittent; 1=Persistant; 2=Single occurance;3=Intermittent, infrequently: <10 mins or <2x; 4=intermittent, frequently: >10 mins or >2x;
withdrawnIntegerRecommendedWas patient withdrawn due to this specific AE?0;10=No; 1=Yes
aesa21e1IntegerRecommendedClinician Rating of Severity for Adverse Event in question e0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7eii
aesa21f1IntegerRecommendedClinician Rating of Severity for Adverse Event in question f0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7fii
aesa21g1IntegerRecommendedClinician Rating of Severity for Adverse Event in question g0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7gii
aesa21h1IntegerRecommendedClinician Rating of Severity for Adverse Event in question h0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7hii
aesa21i1IntegerRecommendedClinician Rating of Severity for Adverse Event in question i0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7iii
aesa21j1IntegerRecommendedClinician Rating of Severity for Adverse Event in question j0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7jii
aesa21k1IntegerRecommendedClinician Rating of Severity for Adverse Event in question k0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7kii
aesa21l1IntegerRecommendedClinician Rating of Severity for Adverse Event in question l0;1;2;3;8;90=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessedael_7lii
ae7adaIntegerRecommendedAdverse event date in days a
ae7bdaIntegerRecommendedAdverse event date in days b
ae7cdaIntegerRecommendedAdverse event date in days c
ae7ddaIntegerRecommendedAdverse event date in days d
ae7edaIntegerRecommendedAdverse event date in days e
ae7fdaIntegerRecommendedAdverse event date in days f
ae7gdaIntegerRecommendedAdverse event date in days g
ae7hdaIntegerRecommendedAdverse event date in days h
ae7idaIntegerRecommendedAdverse event date in days i
ae7jdaIntegerRecommendedAdverse event date in days j
ae7kdaIntegerRecommendedAdverse event date in days k
ae7ldaIntegerRecommendedAdverse event date in days l
saps_ad10IntegerRecommendedRater number
rand_numIntegerRecommendedRandomization Number0::2
ae_descripString30RecommendedStandardized description of eventBased on MOSES
ae_maxmFloatRecommendedIntensity of Event:Mean Value1::41=Mild;2=Moderate;3=Severe;4=Very Severe. Calculated MEAN value will be in the range 1 - 4
ae_maxaIntegerRecommendedIntensity of Event:Maximum Value1::41=Mild;2=Moderate;3=Severe;4=Very Severe. Calculated MAX value will be in the range 1 - 4
ae_intermitString3RecommendedOccurance of Event Intermittent?Y;NY=yes; N=no
ae_reldFloatRecommendedRelation to TrialMedication:Median value1::51=Certain; 2=Probable; 3=Possible; 4=Unrelated; 5=Unassessable
aes5String50RecommendedDescription of Adverse Event20=right; 1=left; 2=both
cbcl1_2_textString500RecommendedDescribe alcohol useTouching in patterns (Current)
sae_38String250Recommended6.2 Course/duration:
sped3_11String500RecommendedOther problems?
bkgrnd_diagString255RecommendedDiagnosis
behavobs_moodString255RecommendedAffect Mood
demo_health_condspString100RecommendedPhysical health conditions: specify
chartreview059String500RecommendedMedical inpatient hospitalizations
scid_event_age7IntegerRecommendedAge at event 7
scid_event_age8IntegerRecommendedAge at event 8
scid_event_age6IntegerRecommendedAge at event 6
scid_event_age5IntegerRecommendedAge at event 5
scid_event_age4IntegerRecommendedAge at event 4
scid_event_age2IntegerRecommendedAge at event 2
scid_event_age1IntegerRecommendedAge at event 1
scid_event_age3IntegerRecommendedAge at event 3
scid_np114String100RecommendedMost upsetting event
scid_np116String100RecommendedEvents past month
scid_event_age9IntegerRecommendedAge at event 9
bg_curothmedsString255RecommendedIf non-psychiatric medications or supplements, list them
med_nmString50RecommendedPsychiatric medication: name
mtypeIntegerRecommendedMed type1::41=Li; 2=NTP; 3 = Other psychiatric medication, 4 = Non-psychiatric medication
ae_10IntegerRecommendedAE Submissions
meddra_commentString500RecommendedMedDRA comments
meddra_hlgt_codeIntegerRecommendedMedDRA code High Level Group Term (HLGT) Subordinate to SOC, superordinate grouping for one or more HLTs10026753=Manic & bipolar mood disorders & disturbances; 10012221=Deliria (incl confusion); 10042460=Suicidal and self-injurious behaviours NEC
meddra_hlgt_termString250RecommendedMedDRA code High Level Group Term (HLGT) Subordinate to SOC, superordinate grouping for one or more HLTs
meddra_hlt_codeIntegerRecommendedMedDRA code High Level Term (HLT) Subordinate to HLGT, superordinate grouping for one or more PTs10027939=Mood alterations with manic symptoms; 10010301=Confusion and disorientation; 10042459=Suicidal and self-injurious behaviour
meddra_htl_termString250RecommendedMedDRA code High Level Term (HLT) Subordinate to HLGT, superordinate grouping for one or more PTs
meddra_llt_codeIntegerRecommendedMedDRA 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_termString250RecommendedMedDRA 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)
meddra_pt_codeIntegerRecommendedMedDRA code Preferred Term (PT) Represents a single medical concept Represents a single medical concept10026749=Mania; 10010305=Confusional state; 10042458=Suicidal ideation
meddra_pt_termString250RecommendedMedDRA code Preferred Term (PT) Represents a single medical concept Represents a single medical concept
meddra_soc_codeIntegerRecommendedMedDRA term System Organ Class (SOC) Highest level of the terminology, and representing an anatomical or physiological system, eti l o ogy, or purpose10037175=Psychiatric disorders
meddra_soc_termString250RecommendedMedDRA term System Organ Class (SOC) Highest level of the terminology, and representing an anatomical or physiological system, eti l o ogy, or purpose
meddra_user_idIntegerRecommendedMedDRA User ID
meddra_versionFloatRecommendedMedDRA Version
meddra_dayIntegerRecommendedMedDRA Days from coding date to baseline visit date
meddra_statusString100RecommendedMedDRA coding status
aer_cIntegerRecommendedPattern of Manifestation: Did this happen more than once? All of the time? Part of the time?1::41 = isolated, happened one time only; 2 = intermittent, infrequently: < 10-minutes or < 2x; 3 = intermittent, frequently: > 10-minutes or > 2x; 4 = continuous
aer_fIntegerRecommendedPossible 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::81 = 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
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

At the top of this page you can also:

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  • Download a copy of this definition in CSV format
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

Please email the The NDA Help Desk with any questions.

Distribution for DataStructure: adev01 and Element:
Chart Help

Filters enable researchers to view the data shared in NDA before applying for access or for selecting specific data for download or NDA Study assignment. For those with access to NDA shared data, you may select specific values to be included by selecting an individual bar chart item or by selecting a range of values (e.g. interview_age) using the "Add Range" button. Note that not all elements have appropriately distinct values like comments and subjectkey and are not available for filtering. Additionally, item level detail is not always provided by the research community as indicated by the number of null values given.

Filters for multiple data elements within a structure are supported. Selections across multiple data structures will be supported in a future version of NDA.