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