Loading...

National Institute of Mental Health Data Archive (NDA) Sign In
NDA

Enter the email address associated with your existing NDA Account and click Continue Linking Process.

If you do not have an existing NDA account, click Go Back.

Warning Notice This is a U.S. Government computer system, which may be accessed and used only for authorized Government business by authorized personnel. Unauthorized access or use of this computer system may subject violators to criminal, civil, and/or administrative action. All information on this computer system may be intercepted, recorded, read, copied, and disclosed by and to authorized personnel for official purposes, including criminal investigations. Such information includes sensitive data encrypted to comply with confidentiality and privacy requirements. Access or use of this computer system by any person, whether authorized or unauthorized, constitutes consent to these terms. There is no right of privacy in this system.
National Institute of Mental Health Data Archive (NDA) Sign In
NDA

Success! An email is on its way!

Please check your email to complete the linking process. The link you receive is only valid for 30 minutes.

Check your spam or junk folder if you do not receive the email in the next few minutes.

Warning Notice This is a U.S. Government computer system, which may be accessed and used only for authorized Government business by authorized personnel. Unauthorized access or use of this computer system may subject violators to criminal, civil, and/or administrative action. All information on this computer system may be intercepted, recorded, read, copied, and disclosed by and to authorized personnel for official purposes, including criminal investigations. Such information includes sensitive data encrypted to comply with confidentiality and privacy requirements. Access or use of this computer system by any person, whether authorized or unauthorized, constitutes consent to these terms. There is no right of privacy in this system.
Create or Link an Existing NDA Account

Warning Notice

This is a U.S. Government computer system, which may be accessed and used only for authorized Government business by authorized personnel. Unauthorized access or use of this computer system may subject violators to criminal, civil, and/or administrative action. All information on this computer system may be intercepted, recorded, read, copied, and disclosed by and to authorized personnel for official purposes, including criminal investigations. Such information includes sensitive data encrypted to comply with confidentiality and privacy requirements. Access or use of this computer system by any person, whether authorized or unauthorized, constitutes consent to these terms. There is no right of privacy in this system.

NIMH Data Archive (NDA) Sign In or Create An Account
Update Password

You have logged in with a temporary password. Please update your password. Passwords must contain 8 or more characters and must contain at least 3 of the following types of characters:

  • Uppercase
  • Lowercase
  • Numbers
  • Special Characters limited to: %,_,!,@,#,$,-,%,&,+,=,),(,*,^,:,;
Update Password

Subscribe to our mailing list

Mailing List(s)
Email Format

You are now leaving the NIMH Data Archive (NDA) web site to go to:

Click on the address above if the page does not change within 10 seconds.

Disclaimer

NDA is not responsible for the content of this external site and does not monitor other web sites for accuracy.

Accept Terms
Data Access Terms - Decline Terms

Are you sure you want to cancel? This will decline terms and you will not be authorized for access.

NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Serious Adverse Events

2,171 Shared Subjects

Clinical Trials: Serious Adverse Events
Clinical Assessments
Adverse Events
05/08/2014
sae01
05/08/2014
View Change History
01
Definition
Submission Template
Query Element Name Data Type Size Required Description Value Range Notes Aliases
subjectkey GUID Required The NDAR Global Unique Identifier (GUID) for research subject NDAR*
src_subject_id String 20 Required Subject ID how it's defined in lab/project CATIEID, SUBJECT, bid, id, newid, pid, saes_01_2, stepid, subject_id, subjectid
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY SAEDate, date_created, sae_date_incident, saes_date_incident, 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, dema1, saea4a, saes_age
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported SEX, dema2, gender, saea3a
Query soc String 100 Recommended SOC System Organ Class Coded variable: MedDRA dictionary, version 4.0: System Organ Class This file contains the MedDRA coded terms for any AEs/side effects that were reported spontaneously by the patient at a visit
prf_term String 100 Recommended Preferred Term Coded variable: MedDRA dictionary, version 4.0: Preferred Term This file contains the MedDRA coded terms for any AEs/side effects that were reported spontaneously by the patient at a visit
Query onset Integer Recommended Onset Day Number of days from study baseline/randomisation to start date of SAE eventdat_sae, onsdate
Query stopdy Integer Recommended SAE Stop Day Number of days from study baseline to stop date of SAE enddate
duration String 25 Recommended Adverse event duration saelength
Query hospexac Integer Recommended Hospitalization due to exacerbation Flag 1=Yes if the SAE resulted in hospitalization due to exacerbation of schizophrenia; missing otherwise
Query hosp1 Integer Recommended 2. Admission Day Number of days from study baseline to date of admission to hospital time_to_hospitalization
Query hosp2 Integer Recommended 3. Discharge Day Number of days from study baseline to date of discharge from hospital time_to_discharge
Query intensty Integer Recommended Adverse Event Severity 1::3 1=mild; 2=moderate; 3=serious
Query outcome Integer Recommended Adverse Event Outcome 1=Fatal; 2=Recovered; 3=Unchanged; 4=Worsened; 5=Improved; 6=Resolved; 7=Unknown; 8=Lasting Damage; 9=Not Reported; 10=Recovered with Treatment; 10000001=Ongoing; 10000101=Recovered with sequelae; 10000201=Unknown/Lost to follow-up outcome_of_sae, sae_outc
Query med_seri Integer Recommended SC -Medically Significant 1=Yes (medically significant); 0 otherwise saea8f
Query hosp3 Integer Recommended 5. Action taken regarding the assigned antipsychotics 0;1 0 = Discontinued; 1 = Continued
Query deathdy Integer Recommended Day of Death Number of days from study baseline/randomization to date of death datedied, datedth, diedrz, saea22
Query dthphase String 2 Recommended Phase During which Death Occurred 1 = Death occurred during Phase 1/1A; 1B = Death occurred during Phase 1B; 2 = Death occurred during Phase 2E/2T; 3 = Death occurred during Phase 3; FU = Death occurred during the Follow-Up Phase
Query dthtrt String 50 Recommended Treatment Patient was on at Time of Death Treatment patient was on at time of death
Query dthdurtr Float Recommended Trtment Duration (wks) at Time of Death Number of weeks patient was receiving study drug in the phase at the time of death
Query phase0 Integer Recommended SAE Emerged during Screening 1 =Yes if the SAE has a start date prior to the start date of Phase 1/1A; missing otherwise
Query phase1 Integer Recommended SAE Emerged Phase 1 1= Yes if the SAE has a start date either during the phase or within 30 days of ending the phase; missing otherwise
Query phase1b Integer Recommended SAE Emerged Phase 1B 1 =Yes if the SAE has a start date either during the phase or within 30 days of ending the phase; missing otherwise
Query phase2 Integer Recommended SAE Emerged Phase 2 1= Yes if the SAE has a start date either during the phase or within 30 days of ending the phase; missing otherwise
Query phase3 Integer Recommended SAE Emerged Phase 3 1=Yes if the SAE has a start date either during the phase or within 30 days of ending the phase; missing otherwise
Query phasefu Integer Recommended SAE Emerged Follow-up Phase 1=Yes if the SAE has a start date either during the phase or within 30 days of ending the phase; missing otherwise
Query durtrt1 Float Recommended Treatment Duration (wks) at onset Phase Number of weeks patient was receiving study drug in the phase at the time the SAE started.
Query durtrt1b Float Recommended Treatment Duration (wks) at onset Phase Number of weeks patient was receiving study drug in the phase at the time the SAE started.
Query durtrt2 Float Recommended Treatment Duration (wks) at onset Phase Number of weeks patient was receiving study drug in the phase at the time the SAE started.
Query durtrt3 Float Recommended Treatment Duration (wks) at onset Phase Number of weeks patient was receiving study drug in the phase at the time the SAE started.
Query durtrtfu Float Recommended Trt Duration (weeks) at onset: FUp Phase Number of weeks patient was receiving study drug in the phase at the time the SAE started.
Query action1 Integer Recommended Action Taken with Respect to Study Drug 0 = Continued; 1 = No Change; 2 = Dose Decreased; 3 = Dose Increased; 4 = Withdrawn; 5 = Unknown; 6 = Non-Drug Therapy; 7 = Concomitant Drug Change; -1 = N/A- SAE Emerged Subsequent to this Phase; 10000001 = None; 10000101 = Discontinued; 10000201 = Interrupted; 10000301 = Not Applicable; 10000401 = Dose Adjusted action_taken, drugactn
Query action1b Integer Recommended Action Taken with Respect to Study Drug 0 = Continued; 1 = No Change; 2 = Dose Decreased; 3 = Dose Increased; 4 = Withdrawn; 5 = Unknown; 6 = Non-Drug Therapy; 7 = Concomitant Drug Change; -1 = N/A- SAE Emerged Subsequent to this Phase; 10000001 = None; 10000101 = Discontinued; 10000201 = Interrupted; 10000301 = Not Applicable; 10000401 = Dose Adjusted
Query action2 Integer Recommended Action Taken with Respect to Study Drug 0 = Continued; 1 = No Change; 2 = Dose Decreased; 3 = Dose Increased; 4 = Withdrawn; 5 = Unknown; 6 = Non-Drug Therapy; 7 = Concomitant Drug Change; -1 = N/A- SAE Emerged Subsequent to this Phase; 10000001 = None; 10000101 = Discontinued; 10000201 = Interrupted; 10000301 = Not Applicable; 10000401 = Dose Adjusted
Query action3 Integer Recommended Action Taken with Respect to Study Drug 0 = Continued; 1 = No Change; 2 = Dose Decreased; 3 = Dose Increased; 4 = Withdrawn; 5 = Unknown; 6 = Non-Drug Therapy; 7 = Concomitant Drug Change; -1 = N/A- SAE Emerged Subsequent to this Phase; 10000001 = None; 10000101 = Discontinued; 10000201 = Interrupted; 10000301 = Not Applicable; 10000401 = Dose Adjusted
Query actionfu Integer Recommended Action Taken - FUp Phase If the SAE occurred within 30 days of ending the phase, then the action taken is set to -1 (''N/A- SAE Emerged Subsequent to this Phase'')
Query anysae1 Integer Recommended Any SAEs in Phase 1 1=Yes if patient has at least one SAE in the phase that was not a hospitalization due to exacerbation of schizophrenia; missing otherwise
Query anysae1b Integer Recommended Any SAEs in Phase 1B 1=Yes if patient has at least one SAE in the phase that was not a hospitalization due to exacerbation of schizophrenia; missing otherwise
Query anysae2 Integer Recommended Any SAEs in Phase 2 1=Yes if patient has at least one SAE in the phase that was not a hospitalization due to exacerbation of schizophrenia; missing otherwise
Query anysae3 Integer Recommended Any SAEs in Phase 3 1=Yes if patient has at least one SAE in the phase that was not a hospitalization due to exacerbation of schizophrenia; missing otherwise
Query anysaefu Integer Recommended Any SAEs in Follow-up Phase 1=Yes if patient has at least one SAE in the phase that was not a hospitalization due to exacerbation of schizophrenia; missing otherwise
Query relat1 Integer Recommended Relationship to Study Drug in Phase 1 1 = Almost Certain; 2 = Probable; 3 = Possible; 4 = Unlikely; 5 = Not Related; 6 = Unknown; 7 = Not Reported; 8 = None; -1 = N/A- SAE Emerged Subsequent to this Phase; 10000001 = Possibly;10000101 = Probably; 10000201 = Definitely; 10000301 = Not Applicable
Query relat1b Integer Recommended Relationship to Study Drug in Phase 1b 1 = Almost Certain; 2 = Probable; 3 = Possible; 4 = Unlikely; 5 = Not Related; 6 = Unknown; 7 = Not Reported; 8 = None; -1 = N/A- SAE Emerged Subsequent to this Phase; 10000001 = Possibly;10000101 = Probably; 10000201 = Definitely; 10000301 = Not Applicable
Query relat2 Integer Recommended Relationship to Study Drug in Phase 2 1 = Almost Certain; 2 = Probable; 3 = Possible; 4 = Unlikely; 5 = Not Related; 6 = Unknown; 7 = Not Reported; 8 = None; -1 = N/A- SAE Emerged Subsequent to this Phase; 10000001 = Possibly;10000101 = Probably; 10000201 = Definitely; 10000301 = Not Applicable
Query relat3 Integer Recommended Relationship to Study Drug in Phase 3 1 = Almost Certain; 2 = Probable; 3 = Possible; 4 = Unlikely; 5 = Not Related; 6 = Unknown; 7 = Not Reported; 8 = None; -1 = N/A- SAE Emerged Subsequent to this Phase; 10000001 = Possibly;10000101 = Probably; 10000201 = Definitely; 10000301 = Not Applicable
Query relatfu Integer Recommended Relationship to Study Drug in Fup Phase 1 = Almost Certain; 2 = Probable; 3 = Possible; 4 = Unlikely; 5 = Not Related; 6 = Unknown; 7 = Not Reported; 8 = None; -1 = N/A- SAE Emerged Subsequent to this Phase; 10000001 = Possibly;10000101 = Probably; 10000201 = Definitely; 10000301 = Not Applicable
Query abate Integer Recommended Did event abate after treatment discontinuation/interruption? 0::2; 999 0=No; 1= Yes; 2=NA; 999=Legitimately skipped saea17b
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
aeendd Date Recommended AE end date MM/DD/YYYY RSDATE, sae_29
Query aescode Integer Recommended Staff code number of person completing this form 999= Missing Data SAECODE, clinid, pnscode
aestdd Date Recommended AE start date MM/DD/YYYY OSDATE
Query autopsy Integer Recommended Was an autopsy performed? 0;1; 999 0 = No; 1 = Yes; 999 = Legitimately Skipped autpsyyn, sae_05, saea23
csdeath String 255 Recommended Cause of death cozdeath, dthcaus, sae_07, saea21
Query death Integer Recommended Serious Criteria: Death 0;1 0=No; 1= Yes sae_03, saea8a, saea9
Query defect Integer Recommended Serious Criteria: Congential anomaly/Birth defect 0;1 0=No; 1= Yes anomaly, canomaly, othcong, sae_08, saea8e
Query dsabl Integer Recommended Serious Criteria: Persistent or significant disabling 0;1 0=No; 1= Yes disable, disablty, sae_09, saea12, saea8d
dthdate String 30 Recommended Date of death sae_04, saedtdth
Query hoppsy Integer Recommended If hospitalization occurred, was the hospitalization due to exacerbation of psychiatric illness? 0::2 1=Yes; 0=No; 2=Not applicable saea9a
Query hsptl Integer Recommended Serious Criteria: Initial or prolonged inpatient hospitalization 0;1 0=No; 1= Yes medsigrh, saea10, saea8c
Query lfthr Integer Recommended Serious Criteria: Life threatening 0;1 0=No; 1= Yes lifethre, lifthret, saea8b
Query reappear Integer Recommended Did the event reappear after reintroduction? 0::2; 999; -8 1=Yes; 0=No; 2=did not reintroduce; 999=Legitimately skipped; -8=NA saea18b
rnddate Date Recommended Date of randomization
rptdate Date Recommended Date of report
Query rptfln Integer Recommended If follow-up report,enter follow up Report number
Query rpttp Integer Recommended Type of Report 1::4 1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report; report_type, saea2, saetmpt_report
Query saeant Integer Recommended Was the situation of this SAE 0::2 1=Anticipated; 0=not Anticipated; 2=Do not know saea11b
saedes String 255 Recommended Describe serious adverse event in chronological order event
saedig String 200 Recommended Diagnosis of Primary SAE event saea5a, saea8
Query saerl String 1 Recommended Relationship to study treatment A; B; C;D; E; F A=Not related; B=Possible; C=Probably; D=Definitely; E= Unknown at this time; F=N/A related, saea12b
Query saers Integer Recommended Has the event been resolved? 0;1 0=No; 1= Yes resolve, saea13a, saea18, saea7
stdate Date Recommended Study Treatment stop date
Query suicide Integer Recommended Was the death because of a suicide? 0;1; 999 0 = No; 1 = Yes; 999 = Legitimately Skipped dsuicide, sae_06, saea20
Query visit String 60 Recommended Visit name month, saetmpt1, timept, visit_name
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 saes_01_3
Query update Integer Recommended Updated form 0;1 1= yes; 0= no
Query daterep Integer Recommended Date reported saea1a
Query crcroaid Integer Recommended CRC or ROA ID
Query saetmpt Integer Recommended SAE time point
Query medsignh Integer Recommended Criteria: medically significant; no hosp 0;1 0=No; 1=Yes sae_11, saea11
Query failedsu Integer Recommended Criteria: failed suicide attempt 0;1 0=No; 1=Yes
Query other Integer Recommended Other prevent dose increase 0;1;999 0 = No; 1 = Yes othcrit, other_ev
Query fumonth Integer Recommended Month in follow-up
Query drrel Integer Recommended Study drug related? 0::4;-3 0=No; 1=Yes; -3=Unknown at this time; 2=Probably; 3=Possibly; 4=Remotely restmed
medication1_name String 500 Recommended Name first medication that the participant has taken 0 = No medication; 999= Legitimately skipped medname1, sae_43, saea24a1, sdrug1
Query mrelat1 Integer Recommended Relation1 0::3 0=none; 1= possibly; 2=probably; 3-definetely drugn1
Query doseadj1 Float Recommended Dose adjustment1 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
medication2_name String 500 Recommended Name second medication that the participant has taken 0 = No medication; 999= Legitimately skipped drugn2, medname2, sae_54, saea24b1, sdrug2
Query mrelat2 Integer Recommended Relation2 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj2 Float Recommended Dose adjustment2 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
medication3_name String 500 Recommended Name third medication that the participant has taken 0 = No medication; 999= Legitimately skipped drugn3, medname3, sae_55, saea24c1, sdrug3
Query mrelat3 Integer Recommended Relation3 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj3 Float Recommended Dose adjustment3 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
medication4_name String 500 Recommended Name fourth medication that the participant has taken 0 = No medication; 999= Legitimately skipped drugn4, medname4, sae_56, saea24d1
Query mrelat4 Integer Recommended Relation4 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj4 Float Recommended Dose adjustment4 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
medication5_name String 500 Recommended Name fifth medication that the participant has taken 0 = No medication; 999= Legitimately skipped medname5, sae_57, saea24e1
Query mrelat5 Integer Recommended Relation5 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj5 Float Recommended Dose adjustment5 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
medication6_name String 500 Recommended Name sixth medication that the participant has taken 0 = No medication; 999= Legitimately skipped medname6, sae_58, saea24f1
Query mrelat6 Integer Recommended Relation6 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj6 Float Recommended Dose adjustment6 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
medication7_name String 500 Recommended Name seventh medication that the participant has taken 0 = No medication; 999= Legitimately skipped medname7, sae_59, saea24g1
Query mrelat7 Integer Recommended Relation7 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj7 Float Recommended Dose adjustment7 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
medication8_name String 500 Recommended Name eighth medication that the participant has taken 0 = No medication; 999= Legitimately skipped medname8, sae_60, saea24h1
Query mrelat8 Integer Recommended Relation8 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj8 Float Recommended Dose adjustment8 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
medication9_name String 500 Recommended Name ninth medication that the participant has taken medname9, sae_61, saea24i1
Query mrelat9 Integer Recommended Relation9 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj9 Float Recommended Dose adjustment9 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
Query medication10_name String 100 Recommended Name tenth medication that the participant has taken medname10, sae_62, saea24j1
Query mrelat10 Integer Recommended Relation10 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj10 Float Recommended Dose adjustment10 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
Query medication11_name String 500 Recommended Medication 11 name medname11, sae_63, saea24k1
Query mrelat11 Integer Recommended Relation11 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj11 Float Recommended Dose adjustment11 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
Query medication12_name String 500 Recommended Med name12 medname12, saea24l1
Query mrelat12 Integer Recommended Relation12 0::3 0=none; 1= possibly; 2=probably; 3-definetely
Query doseadj12 Float Recommended Dose adjustment12 1::5 1=none; 2= discontinued permanently; 3= discontinued temporarily; 4=reduced dose; 5 =increased dose
Query none Integer Recommended Action taken: none 0;1 0=Not checked; 1=Checked sae_22
Query hosp Integer Recommended Action taken: hospitalization 0;1 0=Not checked; 1=Checked hospitalized, sae_23
Query therapyn Integer Recommended Action taken: non-pharm therapy 0;1 0=Not checked; 1=Checked
Query therapyp Integer Recommended Action taken: pharm therapy 0;1 0=Not checked; 1=Checked sae_25
Query exit Integer Recommended Action take: exit study 0;1 0=Not checked; 1=Checked sae_26
Query reslvdat Integer Recommended Date resolved date_sae_resolved, saea13b
Query eventtim Integer Recommended Time of event onset
Query daysrz Integer Recommended days since randomization saea0b, saea1, saea14a
Query dayscons Integer Recommended days since consent
Query certcode Integer Recommended stepbd certification code
Query ptdied Integer Recommended patient died 0;1;-7 0=No; 1=Yes; -7=Refused
Query hospsui Integer Recommended hospitalization due to suicide 0;1;-7 0=No; 1=Yes; -7=Refused hospsuic
Query suiatte Integer Recommended was there suicide attempt 0;1;-7 0=No; 1=Yes; -7=Refused
Query lethscor Integer Recommended lethality score 0::9;-7 -7=Refused
Query intent Integer Recommended patient stated intent 0::2;-7 0=Did not want to die; 1=Unsure if attempt would lead to death; 2=Believed would die; -7=Unknown
Query disab Integer Recommended significant disability 0;1;-7 0=No; 1=Yes; -7=Refused
Query lifethr Integer Recommended life threatening 0;1;-7 0=No; 1=Yes; -7=Refused
Query othca Integer Recommended other criteria cancer 0;1;-7 0=No; 1=Yes; -7=Refused
Query othhaz Integer Recommended other criteria hazard 0;1;-7 0=No; 1=Yes; -7=Refused
Query othodose Integer Recommended other criteria overdose 0;1;-7 0=No; 1=Yes; -7=Refused
Query newhaz Integer Recommended unexpected new hazard 0;1;-7 0=No; 1=Yes; -7=Refused
Query placcont Integer Recommended trial placebo controled 0;1;-7 0=No; 1=Yes; -7=Refused
Query causal Integer Recommended causality 1::5;-7 1=Associated with study drug; 2=Unknown; 3=Not associated with study drug; -7=Refused; 4=Concomitant Drug; 5=Disease under Study; 6=Other Illness
ddose String 50 Recommended daily dose -9=unknown
Query route Integer Recommended route of administer 1::5 1=Oral; 2=Nassal; 3=Smoking; 4=Non IV injection; 5=IV injection
Query indicat String 50 Recommended indication for use
Query txfrz Integer Recommended therapy start days since randomization
Query txtrz Integer Recommended therapy end days since randomization
therdura String 50 Recommended therapy duration
Query expabate Integer Recommended experience abate 0;1;-7 0=No; 1=Yes; -7=Refused
Query expreapp Integer Recommended experience reappear 0;1;-7 0=No; 1=Yes; -7=Refused
Query concdrug Integer Recommended concomitant drugs 0;1;-7 0=No; 1=Yes; -7=Refused
Query dose1 Float Recommended Prescribed Daily Dose in P1 (mg) # of capsules prescribed per day since the last visit multiplied by the capsule strength of treatment. Capsule strength is as follows: OLZ: 7.5 mg; QUET: 200 mg; RISP: 1.5 mg; PER: 8 mg; ZIP: 40 mg. Note: This is the dose in mg. This field does not contain the actual treatment assignment. Treatment assignments are not contained in this file - see file KEYVARS.
route1 String 50 Recommended route 1
Query med1rz Integer Recommended med 1 start days since randomization saea24a3
Query cont1 Integer Recommended drug 1 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24a5
Query med1drz Integer Recommended med 1 discontinued days since randomization saea24a4
Query dose2 Float Recommended Prescribed Daily Dose in P2 (mg) # of capsules prescribed per day since the last visit multiplied by the capsule strength of treatment. Capsule strength is as follows: OLZ: 7.5 mg; QUET: 200 mg; RISP: 1.5 mg; ZIP: 40 mg. CLOZ: as reported in variable MEDAD07. Note: This is the dose in mg. This field does not contain the actual treatment assignment. Treatment assignments are not contained in this file - see file KEYVARS.
route2 String 50 Recommended route 2
Query med2rz Integer Recommended med 2 days since randomization saea24b3
Query cont2 Integer Recommended drug 2 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24b5
Query med2drz Integer Recommended med 2 discontinued days since randomization saea24b4
Query dose3 Float Recommended Prescribed Daily Dose in P3 (mg) As reported in variables MEDAD10 (first Phase 3 treatment) and MEDAD13 (second Phase 3 treatment). Missing if patient was receiving Dual treatment.
route3 String 50 Recommended route 3
Query med3rz Integer Recommended med 3 start days since randomization saea24c3
Query cont3 Integer Recommended drug 3 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24c5
Query med3drz Integer Recommended med 3 discontinued days since randomization saea24c4
dose4 String 50 Recommended dose 4
route4 String 50 Recommended route 4
Query med4rz Integer Recommended med 4 start days since randomization saea24d3
Query cont4 Integer Recommended drug 4 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24d5
Query med4drz Integer Recommended med 4 discontinued days since randomization saea24d4
Query moredrug Integer Recommended more drug 0;1;-7 0=No; 1=Yes; -7=Refused
Query site String 101 Recommended Site Study Site sae_site, site_id, site_uid, siteid
medcur1 String 50 Recommended current medication 1 med1
medcur2 String 50 Recommended current medication 2 med2
medcur3 String 50 Recommended current medication 3 med3
medcur4 String 50 Recommended current medication 4 med4
Query medmon Integer Recommended Trial Monitor 1::4 1=Monitor 1; 2=Monitor 2; 3=Monitor 3; 4=Monitor 4
Query nochange Integer Recommended No change from prev summary 0;1 1=No change
Query saetrue Integer Recommended True SAE 0;1 0=No; 1=Yes saes_03
Query saeexp Integer Recommended Expected SAE 0;1; 9 0=No; 1=Yes; 9=unknown saea11a, saexpect
Query saerel Integer Recommended Drug related 0;1 0=No; 1=Yes
Query sae_code String 5 Recommended SAE codes DS;DN;T;MH;MI;PS;PHS;PHW;PHA;PHO;PHI;PHT;PSI;PST;MP;PHX;PHM;PHSI;PHSA;PHD;PSA;PO DS=Death-suicide; DN=Death-non suicide; T=Suspected serious side effect of medication treatment; MH=Medical event-hospitalization; MI=Medical event-illness/symptom/diagnosis not requiring hospitalization; PS=Psychiatric event-suicidal ideation (non hospitalized); PHS=Psychiatric event-hospitalization/suicide attempt or ideation; PHW=Psychiatric event-hospitalization/worsening depression; PHA=Psychiatric event-hospitalization/substance abuse detoxification; PHO=Psychiatric event-hospitalization/psychiatric event other than above; PHI=Psychiatric event-hospitalization/illness; PHT=Psychiatric event-hospitalization/side effect of med treatment; PSI=Psychiatric event-suicidal ideation/illness; PST=Psychiatric event-suicidal ideation/side effect of med treatment; MP=Medical Procedure (e.g., delivery of baby); PHX=Psychiatric event-hospitalization involving increase of mixed symptoms; PHM=Psychiatric event-hospitalization involving increase of manic or hypomanic symptoms; PHSI=Psychiatric event-hospitalization involving suicidal ideation; PHSA=Psychiatric event-hospitalization involving suicidal attempt; PHD=Psychiatric event-hospitalization involving increase of depressive symptoms; PSA=Psychiatric event-suicide attempt; PO=Psychiatric-event Other sae, saecd
dscript1 String 250 Recommended Description 1 saea24a2
dscript2 String 250 Recommended Description 2 saea24b2
Query dscript3 String 250 Recommended Description 3 saea24c2
Query dscript4 String 250 Recommended Description 4 saea24d2
dscript5 String 250 Recommended Description 5 saea24e2
flwup1 String 250 Recommended Followup 1
flwup2 String 250 Recommended Followup 2
Query saenumber Integer Recommended SAE Number sae_number, saefunum
Query exprrz Integer Recommended experience onset days since randomization saea6a
Query rslvrz Integer Recommended sae resolution days since rz
Query rcpenrl Integer Recommended rcp enrol during sae 0;1;-7 0=No; 1=Yes; -7=Refused
Query rcpptway Integer Recommended rcp pathway 1::9 1=SCP; 2=AD-Acute Depression; 3=REFD-Refractory Dep; 4=RELP-Relapse Prevent; 5=Psy-AD-Psychosocial; 6=Psy-REL-Psychosocial; 7=Omega 3; 8=LiMRS; 9=PAD-Psychosocial
Query sae_10 Integer Recommended 1.4 Medically significant: requiring hospitalization 0;1 0=No; 1=Yes hospital
Query sae_12 Integer Recommended 1.6 Suicidal ideation requiring hospitalization 0;1 0=No; 1=Yes hosppsy
Query sae_13 Integer Recommended 1.7 Psychiatric condition requiring hospitalization 0;1 0=No; 1=Yes psychosp, psyexit, saea10b
Query sae_14 Integer Recommended 1.8 Psychiatric condition requiring study exit 0;1 0=No; 1=Yes
Query sae_15 Integer Recommended 1.8.1 Hypomania 0;1 0=No; 1=Yes hypo, psy_hypo, saes_13
Query sae_16 Integer Recommended 1.8.2 Mania 0;1 0=No; 1=Yes mania, psy_mania, saes_12
Query sae_17 Integer Recommended 1.8.3 Psychosis 0;1 0=No; 1=Yes psy_pychos, psychos, saes_14
Query sae_18 Integer Recommended 1.9 Suicide behavior (check all that apply): 0;1 0=No; 1=Yes suic_beh
Query sae_19 Integer Recommended 1.9.1 Deliberate self harm 0;1 0=No; 1=Yes del_selfharm, saes_09, selfharm
Query sae_20 Integer Recommended 1.9.2 Actual attempt 0;1 0=No; 1=Yes act_atmp, saes_10, suicattp
Query sae_21 Integer Recommended 1.10 Other 0;1 0=No; 1=Yes
Query sae_36 Integer Recommended 4. Study drug related (clinician's determination)? 0::3 0=No; 1=Possibly; 2=Probably; 3=Definitely drrel_1, saea12a, saes_05
sae_37 String 250 Recommended 6.1 Symptoms
sae_38 String 250 Recommended 6.2 Course/duration:
sae_39 String 250 Recommended 6.3 Treatment
sae_40 String 250 Recommended 6.4 Sequelae:
sae_41 String 250 Recommended 7. Relevant tests/laboratory data:
sae_42 String 500 Recommended 8. Relevant medical history
comment_misc String 250 Recommended Miscellaneous Comments
medication1_dose String 50 Recommended Medication 1 dose last taken camsdose1, sae_64
medication2_dose String 50 Recommended Medication 2 dose last taken camsdose2, sae_65
medication3_dose String 50 Recommended Medication 3 dose last taken camsdose3, sae_66
medication4_dose String 50 Recommended Medication 4 dose last taken camsdose4, sae_67
medication5_dose String 50 Recommended Medication 5 dose last taken camsdose5, sae_68
medication6_dose String 50 Recommended Medication 6 dose last taken camsdose6, sae_69
medication7_dose String 50 Recommended Medication 7 dose last taken camsdose7, sae_70
medication8_dose String 50 Recommended Medication 8 dose last taken camsdose8, sae_71
medication9_dose String 50 Recommended Medication 9 dose last taken camsdose9, sae_72
medication10_dose String 100 Recommended Medication 10 dose last taken camsdose10, sae_73
Query medication1_day Integer Recommended Medication 1 number of days sae_74
Query medication2_day Integer Recommended Medication 2 number of days sae_75
Query medication3_day Integer Recommended Medication 3 number of days sae_76
Query medication4_day Integer Recommended Medication 4 number of days sae_77
Query medication5_day Integer Recommended Medication 5 number of days sae_78
Query medication6_day Integer Recommended Medication 6 number of days sae_79
Query medication7_day Integer Recommended Medication 7 number of days sae_80
Query medication8_day Integer Recommended Medication 8 number of days sae_81
Query medication9_day Integer Recommended Medication 9 number of days sae_82
Query medication10_day Integer Recommended Medication 10 number of days sae_83
ccc2datecomp Date Recommended Date Completed sae_84
Query sae_86 Integer Recommended Information Complete 0;1 0=No; 1=Yes
Query sae_87 Integer Recommended 2.3 Remedial Therapy: Non-pharmacological 0;1 0=No; 1=Yes
Query sae_88 Integer Recommended select to send email to SO 0;1 0=No; 1=Yes
sae_date_entered Date Recommended SAE entered into STX: saes_date_entered
sae_reported_date_sc Date Recommended Site Coordinator informed
sae_reported_time_sc String 20 Recommended Time reported to sc saes_time_reported_sc
sae_reported_to_date Date Recommended date sae reported to pi saes_date_reported
sae_reported_to_time String 20 Recommended time reported to SO
sae_time_entered String 20 Recommended time entered into STX saes_time_entered
sae_time_incident String 20 Recommended Time of incident saes_time_incident, timehr
Query saes_01 Integer Recommended Checks if resolved 0;1 0=No; 1=Yes
Query saes_02 Integer Recommended Checks for change from previous summary 0;1 0=No; 1=Yes
Query saes_04 Integer Recommended Check if SAE was a true SAE then 0;1 0=No; 1=Yes
Query saes_06 Integer Recommended Check if the option differs from SAE 0;1 0=No; 1=Yes
Query saes_07 Integer Recommended Checks if SAE was a psychiatric event 0;1 0=No; 1=Yes psyevent
Query saes_08 Integer Recommended Check if a suicidal idealization 0;1 0=No; 1=Yes suicidea
Query saes_11 Integer Recommended Check if a Worsening depression 0;1 0=No; 1=Yes worsedep
Query saes_15 Integer Recommended Check if Substance abuse detoxification 0;1 0=No; 1=Yes detox
Query saes_16 Integer Recommended Check if anything other than listed 0;1 0=No; 1=Yes other1
saes_17 String 20 Recommended Collects SAE code
saes_18 String 250 Recommended Describes the event
saes_19 String 250 Recommended Suggests follow up procedures
Query visitid Integer Recommended MetaTrial Visit ID System variable: unique code for each type of visit -use to merge files
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 sae0b Integer Recommended Visit Date
Query saea3 Integer Recommended Date of Onset date1, evntdate, onset_date_sae
Query saea4 Integer Recommended Age at onset, months 0::1200 age_ev
Query saea5 Integer Recommended Date of randomization: (from DMS) saea14a1
Query saea6 Integer Recommended Date of last injection to onset: (from DMS)
saea10b1 String 20 Recommended If yes, indicate primary reason: A=Psychotic symptoms; B=Substance abuse (e.g., detox); C=Suicidality; D=Other psychiatric symptoms (e.g. depression, anxiety)
Query saea14 Integer Recommended Is an SAE narrative included (see instructions below) 0;1 0=No; 1= Yes
Query saea15 String 2 Recommended Was this SAE A;B;C A= anticipated; B=not anticipated; C=Unknown at this time
Query saea16 String 2 Recommended Relationship to study drug A;B;C;D;E A=Related; B=Not Related; C=Probable; D=Possible; E=Unlikely relat_to_study_drug
Query saea17 String 2 Recommended Action taken regarding study drug: A;B;C;D;E;F;G;H;I A=None; B=Discontinued; C=Interrupted Study Treatment; D=Dose Adjusted; Not Applicable; F=Unknown at this time; G=Reduced Dose; H=Increased Dose; I=Delayed Dose saea16a
Query saea17a Integer Recommended Date action taken
Query saea18a Integer Recommended If yes, date event resolved:
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 outcomecams, saea19a
Query saea19b Integer Recommended Date of Death
version_form String 121 Recommended Form used/assessment name form_name, vers
Query visday Integer Recommended Number of days from study baseline to date of visit date, daysae
Query saea10c Integer Recommended Date of hospitalization discharge calculated from randomization date
subject_description String 4,000 Recommended Subject related information (e.g the affection, phenotype, disease information, etc.).
saea5ex String 200 Recommended SAEA5 Extension: Provides the rest of the Primary Event/Diagnosis if original value in variable SAEA5 was over 200 character length limit
Query saea7a Integer Recommended If yes, Date Event Resolved [days since randomization]: -200::200
Query saea13 Integer Recommended Current Study Drug Start Date [days since randomization]: -500::500 drugdate
Query saea15a Integer Recommended Did the patient stop taking study drug? 0;1 0=No; 1=Yes
Query saea15b Integer Recommended If yes, Current Study Drug Stop Date [days since randomization]: 0::230 lastdose
Query sae9dt Integer Recommended SAE onset date associated with first occurrence of 'hospitalization due to exacerbation of psychiatric illness' (SAEA9='1' on SAE form) [ converted to days from randomization] 0::500
Query sae9vis Integer Recommended SAE Psychiatric Hospitalization Visit 2;3;4;5;6;7;8;10 2=baseline, week 0; 3=week 1; 4=week 2; 5=week 3; 6=week 4; 7=week8; 8=week 12; 10=week20
Query iphosp Integer Recommended Indicator for Psychiatric Hospitalization (based on PSYCHOSP) 0;1 0=Otherwise; 1=At least one occurrence of psychiatric hospitalization
Query med5rz Integer Recommended med 5 start days since randomization saea24e3
Query cont5 Integer Recommended drug 5 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24e5
Query med5drz Integer Recommended med 5 discont days since randomization saea24e4
Query med6rz Integer Recommended med 6 start days since randomization saea24f3
Query cont6 Integer Recommended drug 6 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24f5
Query med6drz Integer Recommended med 6 discont days since randomization saea24f4
Query med7rz Integer Recommended med 7 start days since randomization saea24g3
Query cont7 Integer Recommended drug 7 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24g5
Query med7drz Integer Recommended med 7 discont days since randomization saea24g4
Query med8rz Integer Recommended med 8 start days since randomization saea24h3
Query cont8 Integer Recommended drug 8 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24h5
Query med8drz Integer Recommended med 8 discont days since randomization saea24h4
Query med9rz Integer Recommended med 9 start days since randomization saea24i3
Query cont9 Integer Recommended drug 9 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24i5
Query med9drz Integer Recommended med 9 discont days since randomization saea24i4
Query med10rz Integer Recommended med 10 start days since randomization saea24j3
Query cont10 Integer Recommended drug 10 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24j5
Query med10drz Integer Recommended med 10 discont days since randomization saea24j4
Query med11rz Integer Recommended med 11 start days since randomization saea24k3
Query cont11 Integer Recommended drug 11 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24k5
Query med11drz Integer Recommended med 11 discont days since randomization saea24k4
Query med12rz Integer Recommended med 12 start days since randomization saea24l3
Query cont12 Integer Recommended drug 12 continued 0;1;-7 0=No (discontinued); 1=Yes; -7=Refused saea24l5
Query med12drz Integer Recommended med 5 discont days since randomization saea24l4
dscript6 String 250 Recommended Description 6 saea24f2
dscript7 String 250 Recommended Description 7 saea24g2
dscript8 String 250 Recommended Description 8 saea24h2
dscript9 String 250 Recommended Description 9 saea24i2
dscript10 String 250 Recommended Description 10 saea24j2
dscript11 String 250 Recommended Description 11 saea24k2
dscript12 String 250 Recommended Description 12 saea24l2
mdga20a String 150 Recommended Medical Illness 1 saea26a1
mdga20b String 150 Recommended Medical Illness 2 saea26b1
mdga20c String 150 Recommended Medical Illness 3 saea26c1
mdga20d String 150 Recommended Medical Illness 4 saea26d1
Query saea26a2 Integer Recommended med illness 1 start days since randomization
Query saea26b2 Integer Recommended med illness 2 start days since randomizaiton
Query saea26c2 Integer Recommended med illness 3 start days since randomization
Query saea26d2 Integer Recommended med illness 4 start days since randomization
Query saea26a3 Integer Recommended med illness 1 stop days since randomization
Query saea26b3 Integer Recommended med illness 2 stop days since randomizaiton
Query saea26c3 Integer Recommended med illness 3 stop days since randomization
Query saea26d3 Integer Recommended med illness 4 stop days since randomization
Query saea26a3a Integer Recommended med illness 1 ongoing 0;1 0 = No; 1 = Yes
Query saea26b3a Integer Recommended med illness 2 ongoing 0;1 0 = No; 1 = Yes
Query saea26c3a Integer Recommended med illness 3 ongoing 0;1 0 = No; 1 = Yes
Query saea26d3a Integer Recommended med illness 4 ongoing 0;1 0 = No; 1 = Yes
session_id String 20 Recommended session ID/screening ID screening_id, screeningid
Query aeid Integer Recommended Adverse event identifier sae_id
aeterm String 250 Recommended Verbatim Term verbatim_sae_term_field
description_of_sae String 800 Recommended Description of SAE:
sae_action_other_txt String 250 Recommended Action taken to Treatment Other Text
Query ae_serious_death Integer Recommended SAE Serious because of Death
Query ae_serious_disable Integer Recommended SAE Serious because of Disability/Incapacity
Query ae_serious_hospital Integer Recommended SAE Serious because of Hospitalization
Query ae_serious_threat Integer Recommended SAE Serious because of Life-Threatening
Query ae_serious_anomaly Integer Recommended SAE Serious because of Congenital Anomaly
Query ae_serious_signific Integer Recommended SAE Serious because of Medically Significant 0;1 0 = No; 1 = Yes signfcnt
Query sae_sequelae Integer Recommended SAE Outcome with Sequelae
saeothsp String 600 Recommended SAE Outcome Other Specify
autpsydt Date Recommended Date of Autopsy
Query weight_met Float Recommended Weight - Metric Unit 999 = Missing; -999 = No Data saewgt
requestsae String 250 Recommended Request for additional information
comments_misc String 4,000 Recommended Miscellaneous comments on study, interview, methodology relevant to this form data addlinfo
reason_for_rejection String 250 Recommended Please, specify reason for rejection or disapproval:
study String 100 Recommended Study; The code for each individual study
Query q1_14a1 Integer Recommended Medication Code 1 1 :: 2099
Query q1_14b1 Integer Recommended Medication Code 2 1 :: 2099
Query q1_14c1 Integer Recommended Medication Code 3 1 :: 2099
Query q1_14d1 Integer Recommended Medication Code 4 1 :: 2099
Query q1_14e1 Integer Recommended Medication Code 5 1 :: 2099 med5
Query q1_14f1 Integer Recommended Medication Code 6 1 :: 2099 med6
Query q1_14g1 Integer Recommended Medication Code 7 1 :: 2099 med7
Query q1_14h1 Integer Recommended Medication Code 8 1 :: 2099 med8
Query q1_14i1 Integer Recommended Medication Code 9 1 :: 2099 med9
Query q1_16a1 Integer Recommended Medication Code 1 (Autism medication not previously mentioned) 1 :: 2099 med10
Query q1_16b1 Integer Recommended Medication Code 2 (Autism medication not previously mentioned) 1 :: 2099 med11
Query q1_16c1 Integer Recommended Medication Code 3 (Autism medication not previously mentioned) 1 :: 2099 med12
Query phase Integer Recommended Phase 9 =follow up
Query sae_sent Integer Recommended Sae sent 0;1 0=No; 1=Yes
Query saes_sent Integer Recommended Saes sent 0;1 0=No; 1=Yes
Query phaseoc Integer Recommended SAE Emerged OC Phase 1=Yes, if the SAE has a start date on/after phase start date and within 10 days of ending the phase; missing otherwise
Query durtrtoc Float Recommended Treatment Duration (wks) at onset OC Pha Number of weeks patient was receiving study drug in the phase at the time the SAE started.
Query actionoc Integer Recommended Action Taken w/ Respect to StDrug in OC . = ; 1 = No Change; 2 = Dose Decreased; 3 = Dose Increased; 4 = Withdrawn; 5 = Unknown; 6 = Non-Drug Therapy; 7 = Concomitant Drug Change; (-1) = N/A- SAE Emerged Subsequent to this Phase; 10000001 = None; 10000101 = Discontinued; 10000201 = Interrupted; 10000301 = Not Applicable; 10000401 = Dose Adjusted
Query anysaeoc Integer Recommended Any SAEs in OC Phase 1=Phase 1; 2=Phase 2; 3=Phase 3; 4=Open Choice Phase; 5=Death occurred in unknown phase
Query relatoc Integer Recommended Relationship to Study Drug in OC Phase . = ; 1 = Almost Certain; 2 = Probable; 3 = Possible; 4 = Unlikely; 5 = Not Related; 6 = Unknown; 7 = Not Reported; 8 = None; (-1) = N/A- SAE Emerged Subsequent to this Phase; 10000001 = Possibly; 10000101 = Probably; 10000201 = Definately; 10000301 = Not Applicable
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 eoc_day Integer Recommended Visit Day Discontinued from Open Choice Number of days from study baseline to end date of phase
Query weight_std Float Recommended Weight - Standard Unit -1 = Not known; 999 = Missing weightsae
Query unblind Integer Recommended Was Blind Broken? 0;1 0=No; 1=Yes
Query medication1_route Integer Recommended Route medication 1 1::4 1=Oral; 2=IV; 3=IM; 4=Other croute1
q53_b6a2 String 100 Recommended Medication 1 Indication Indicate use of medication ndicatn1
Query hi_31a5 Integer Recommended Medication 1 days from baseline started med1strt_s
Query hi_31a6 Integer Recommended Medication 1 days from baseline stopped med1end_s
Query medication2_route Integer Recommended Route medication 2 1::4 1=Oral; 2=IV; 3=IM; 4=Other croute2
q53_b6b2 String 100 Recommended Medication 2 Indication Indicate use of medication ndicatn2
Query hi_31b5 Integer Recommended Medication 2 days from baseline started med2strt_s
Query hi_31b6 Integer Recommended Medication 2 days from baseline stopped med2end_s
Query medication3_route Integer Recommended Route medication 3 1::4 1=Oral; 2=IV; 3=IM; 4=Other croute3
q53_b6c2 String 100 Recommended Medication 3 Indication Indicate use of medication ndicatn3
Query hi_31c5 Integer Recommended Medication 3 days from baseline started med3strt_s
Query hi_31c6 Integer Recommended Medication 3 days from baseline stopped med3end_s
Query medication4_route Integer Recommended Route medication 4 1::4 1=Oral; 2=IV; 3=IM; 4=Other croute4
q53_b6d2 String 100 Recommended Medication 4 Indication Indicate use of medication ndicatn4
Query hi_31d5 Integer Recommended Medication 4 days from baseline started med4strt_s
Query hi_31d6 Integer Recommended Medication 4 days from baseline stopped med4end_s
Query medication5_route Integer Recommended Route medication 5 1::4 1=Oral; 2=IV; 3=IM; 4=Other croute5
q53_b6e2 String 100 Recommended Medication 5 Indication Indicate use of medication ndicatn5
Query hi_31e5 Integer Recommended Medication 5 days from baseline started med5strt_s
Query hi_31e6 Integer Recommended Medication 5 days from baseline stopped med5end_s
Query suspect Integer Recommended Do you suspect concomitant drug as playing a role in the event? 0::5 0=No;1=Yes;2=Maybe;3=Probably; 4=Possibly; 5=Remotely
Query conmed1 Integer Recommended Medication 1 is suspected of playing a role in the event 0;1 0=No; 1=Yes
Query conmed2 Integer Recommended Medication 2 is suspected of playing a role in the event 0;1 0=No; 1=Yes
Query conmed3 Integer Recommended Medication 3 is suspected of playing a role in the event 0;1 0=No; 1=Yes
Query conmed4 Integer Recommended Medication 4 is suspected of playing a role in the event 0;1 0=No; 1=Yes
Query conmed5 Integer Recommended Medication 5 is suspected of playing a role in the event 0;1 0=No; 1=Yes
labtest1 String 50 Recommended LabTest1: Description
Query tstdate1 Integer Recommended Day of Test1
result1 String 50 Recommended LabTest1: Result
labtest2 String 50 Recommended LabTest2: Description
Query tstdate2 Integer Recommended Day of Test2
result2 String 50 Recommended LabTest2: Result
labtest3 String 50 Recommended LabTest3: Description
Query tstdate3 Integer Recommended Day of Test3
result3 String 50 Recommended LabTest3: Result
labtest4 String 50 Recommended LabTest4: Description
Query tstdate4 Integer Recommended Day of Test4 run
result4 String 50 Recommended LabTest4: Result
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 timeampm Integer Recommended Time of incident AM or PM 1;2 1=AM; 2=PM
Query vis_type Integer Recommended Visit type 0::2 1=Phone/remote; 0=doctor's office/In person; 2=No, not phone interview phone
date_updated Date Recommended Date record updated edit_date
Query action_taken1 Integer Recommended Action Taken with respect to study treatment 1::4 1=None; 2=Treatment reduced; 3=Treatment discontinued; 4=Other, specify
Query outcome_of_sae1 Integer Recommended Outcome of SAE 1::9 1=Death; 2=Resolved without sequelae; 3=Resolved with sequelae; 4=Condition still present; 5=Change in AE status/characteristic; 6=Lost to follow up; 7=Other, specify; 8=NK; 9=Not resolved
parent_id String 20 Recommended Parent ID
lhq_hosp2 String 100 Recommended If yes, what was the reason for hospitalization reason_for_hospitalization
type_hosp String 100 Recommended Type of hospital type_of_hospital
Query withdrawn Integer Recommended Was patient withdrawn due to this specific AE? 0;1 0=No; 1=Yes
Query q53_a3a Integer Recommended Weight lbs -7;-8;-9; 20 :: 400 Field should not be left blank. If missing, please use -7,8, -9.
Query recoverydays Integer Recommended Days from baseline recovered from AE
Query reinte Integer Recommended Intervention to Prevent Permannet Impairment/Damage 0;1 0=No;1=Yes
Query medreint Integer Recommended Was Study Drug Reintroduced (or dose increased)? 0;1 0=No;1=Yes
Query saerecur Integer Recommended Study drug was interrupted, stopped or dose reduced 0;1 0=No;1=Yes
offstime String 15 Recommended End of Event Time hh:mm
Query mtype Integer Recommended Med type 1::4 1=Li; 2=NTP; 3 = Other psychiatric medication, 4 = Non-psychiatric medication
adl_q04 String 20 Recommended Time of last study med -888=NA
Query sae_9 Integer Recommended Is the expiration date of study medication known? 1;-8 1=Yes, Expiration date known; -8=Not Applicable
lot_number String 250 Recommended Lot Number Yes = Lot Number Known
Query sae_12edo_day Integer Recommended Days from date of drug restarted to baseline visit date
Query sae_12edob_day Integer Recommended Days from date of drug interrupted to baseline visit date
Query ldosedy Integer Recommended Day of last dose Number of days from study baseline to date of last dose
Query sae_9day Integer Recommended Days from expiration date of study medication to baseline visit date
inilspec String 100 Recommended Alternate causes of the AE: Concomitant illness specify
Query ptdose Integer Recommended Dose level prescribed in this session
Query race String 30 Recommended Race of study subject
American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White; Other
v1_mh_cap5_startdate String 10 Recommended Condition 5 Start Date (symptoms)
study_drug_team String 30 Recommended Study drug Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
Query sae_cte Integer Recommended Confirmatory Tests for Event 1;2 1 = None; 2 = Unknown
Query sae_16c Integer Recommended Medication 2 dose level
Query sae_17c Integer Recommended Medication 3 dose level
Query sae_23e Integer Recommended Concomitant Medication 1 Ongoing 0;1 0 = No; 1 = Yes
Query sae_24e Integer Recommended Concomitant Medication 2 Ongoing 0;1 0 = No; 1 = Yes
Query sae_25e Integer Recommended Concomitant Medication 3 Ongoing 0;1 0 = No; 1 = Yes
Query sae_ro Integer Recommended Origin of Report 1;2 1 = Site; 2 = CC/CRA
Query rand_num Integer Recommended Randomization Number 0::2
aespdtm String 25 Recommended AE End date and time
Query sae_permseq Integer Recommended Serious Adverse Event: any permanent sequelae 0;1 0=No; 1= Yes
Query sae_randmed Integer Recommended Serious Adverse Event: Random Medical event? 0;1 0=No; 1= Yes
Query sae_random Integer Recommended Serious Adverse Event: Subject Randomized at time of Event? 0;1 0=No; 1= Yes
ca17 Date Recommended Entry into study date
Query height_met Float Recommended Height - Metric Unit 999 = Missing; -999 = No Data
q53_b1a Date Recommended Date of onset MM/DD/YYYY Required field
strmedend1 Date Recommended What was the end date?
medication2_start Date Recommended Medication 2 start
medication3_start Date Recommended Medication 3 start
medication3_stop Date Recommended Medication 3 stop
medication4_start Date Recommended Medication 4 start
medication4_stop Date Recommended Medication 4 stop
medication5_start Date Recommended Medication 5 start
medication5_stop Date Recommended Medication 5 stop
medication6_start Date Recommended Medication 6 start
medication6_stop Date Recommended Medication 6 stop
q53_b6f2 String 100 Recommended Medication 6 Indication Indicate use of medication
lab020 Date Recommended Date of PI/clinician signature
route5 String 50 Recommended route 5
route6 String 50 Recommended route 6
stdate1 String 20 Recommended Medication start date 1 mm/dd/yyyy or write out month year
Data Structure

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

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

At the top of this page you can also:

  • Use the search bar to filter the elements displayed. This will not filter on the Size of Required columns
  • Download a copy of this definition in CSV format
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

Please email the The NDA Help Desk with any questions.

Additional Information
Training Privacy Policy Disclaimer Contact Us
External Resources
Accessibility FOIA OIG HHS Vulnerability Disclosure
NIH Logo HHS Logo USA Gov Logo
c725efb98f608e6bc0136950f08b0c3af2bde994