|
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 |
|
|
|
|
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
|
|