Informed consent, DNA Sample
Item
Did the subject sign a DNA informed consent form?
boolean
C0021430 (UMLS CUI [1,1])
C0444245 (UMLS CUI [1,2])
Date of informed consent, DNA Sample
Item
lf 'Yes,' provide date of signature:
date
C2985782 (UMLS CUI [1,1])
C0444245 (UMLS CUI [1,2])
Deoxyribonucleic acid sample; Storage; legal regulation
Item
Did local or country regulations limit the length of storage for this subject's DNA sample?
boolean
C0444245 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C0680575 (UMLS CUI [1,3])
Item
If 'Yes', specify the storage limit:
integer
C0444245 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0439234 (UMLS CUI [1,4])
Code List
If 'Yes', specify the storage limit:
Specification DNA Sample Storage limit
Item
If storage limit is 'Other', specify the number of years the sample may be stored:
integer
C2348235 (UMLS CUI [1,1])
C0444245 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
C0439234 (UMLS CUI [1,4])
Agree to DNA testing
Item
Did the subject agree to study-specific DNA testing? (Part 1)
boolean
C1658606 (UMLS CUI [1,1])
C3641827 (UMLS CUI [1,2])
Agree to DNA sample storage
Item
Did the subject agree to DNA sample storage for future testing? (Part 2)
boolean
C0444245 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C3641827 (UMLS CUI [1,3])
Blood sample for DNA testing
Item
Was a blood sample for DNA testing obtained?
boolean
C0005834 (UMLS CUI [1,1])
C1658606 (UMLS CUI [1,2])
Date sample obtained
Item
Date sample obtained
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date of DNA informed consent form modifying original decision
Item
Date of signature on DNA informed consent form modifying original decision regarding DNA sampling/storage
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0444245 (UMLS CUI [1,3])
C3840684 (UMLS CUI [1,4])
Agree to DNA testing
Item
Does the subject agree to study-specific DNA testing at this time? (Part 1)
boolean
C1658606 (UMLS CUI [1,1])
C3641827 (UMLS CUI [1,2])
Agree to DNA Sample Storage
Item
Does the subject agree to DNA sample storage for future testing at this time? (Part 2)
boolean
C0444245 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C3641827 (UMLS CUI [1,3])
Blood sample for DNA testing
Item
Was a blood sample for DNA testing obtained?
boolean
C0005834 (UMLS CUI [1,1])
C1658606 (UMLS CUI [1,2])
Date sample obtained
Item
Date sample obtained
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date of additional blood sample for DNA testing
Item
Date of additional blood sample for DNA testing
date
C0011008 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
C1658606 (UMLS CUI [1,4])
Reason for additional sample
Item
Reason for additional sample
text
C0566251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
C1658606 (UMLS CUI [1,4])
Subject referred to a dermatologist for the evaluation of an injection site reaction
Item
Was the subject referred to a dermatologist or surgeon at any time during the course of the study for the evaluation of an injection site reaction (distinct from a general skin reaction)?
boolean
C0034927 (UMLS CUI [1,1])
C0011627 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0151735 (UMLS CUI [1,4])
Date of referral to dermatologist
Item
Date of referral
date
C0011008 (UMLS CUI [1,1])
C0034927 (UMLS CUI [1,2])
C0011627 (UMLS CUI [1,3])
Item
Reason for referral
integer
C0566251 (UMLS CUI [1,1])
C0034927 (UMLS CUI [1,2])
C0011627 (UMLS CUI [1,3])
Code List
Reason for referral
CL Item
Suspected cellulitis (1)
CL Item
Suspected abscess (2)
CL Item
Suspected non-infectious reaction (nodule, fibroma, etc) (3)
Specification reason for referral
Item
If 'Other', specify:
text
C2348235 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0034927 (UMLS CUI [1,3])
C0011627 (UMLS CUI [1,4])
Date of withdrawal from Open Label Phase
Item
Date of withdrawal from Open Label Phase
date
C4284321 (UMLS CUI [1,1])
C1709323 (UMLS CUI [1,2])
C0205390 (UMLS CUI [1,3])
Item
Reason for early withdrawal from Open Label Phase
integer
C0566251 (UMLS CUI [1,1])
C2718058 (UMLS CUI [1,2])
C1709323 (UMLS CUI [1,3])
C0205390 (UMLS CUI [1,4])
Code List
Reason for early withdrawal from Open Label Phase
CL Item
Adverse event (1)
CL Item
Lack of efficacy (3)
CL Item
Lost to follow-up (4)
CL Item
Screen failure (5)
CL Item
Withdrawal of consent (7)
CL Item
Subject failed to meet randomization criteria to enter the Double-Blind phase (8)
Item
If Subject failed to meet criteria to enter the Double-Blind phase, please specify:
integer
C2348235 (UMLS CUI [1,1])
C3828770 (UMLS CUI [1,2])
C0013072 (UMLS CUI [1,3])
C0205390 (UMLS CUI [1,4])
Code List
If Subject failed to meet criteria to enter the Double-Blind phase, please specify:
CL Item
PANSS total score >= 70 at Visits 7 or 8 (Weeks 14 or 17) (1)
CL Item
PANSS Item P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility), G8 (uncooperativeness) or G14 (poor impulse control) at Visits 7 or 8 (Weeks 14 or 17) scores > 4 (2)
CL Item
No reduction in CGI-S score at Visits 7 or 8 (Weeks 14 or 17) (3)
Specification reason for early termination
Item
If reason for early termination is 'Other,' specify:
text
C2348235 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C2718058 (UMLS CUI [1,3])
Adverse event log line, start date and term
Item
If reason is 'Adverse Event,' specify corresponding AE log line, start date, and term:
text
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C1708728 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C2826302 (UMLS CUI [3,2])
Pregnancy due date
Item
Pregnancy due date
date
C0032961 (UMLS CUI [1,1])
C2825543 (UMLS CUI [1,2])
Participation in the study per protocol
Item
Did the subject complete participation in the study per protocol?
boolean
C2348577 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Date of completion or early termination from the Double-Blind Phase
Item
Date of completion or early termination from the Double-Blind Phase
date
C0011008 (UMLS CUI [1,1])
C2718058 (UMLS CUI [1,2])
C0013072 (UMLS CUI [1,3])
C0205390 (UMLS CUI [1,4])
Item
If 'Yes', indicate category:
integer
C2348235 (UMLS CUI [1,1])
C2348577 (UMLS CUI [1,2])
Code List
If 'Yes', indicate category:
CL Item
Completed the trial (1)
CL Item
Relapse during double blind phase (2)
Item
If 'No', indicate the reason for the subject's early termination from the Double-Blind Phase:
integer
C0566251 (UMLS CUI [1,1])
C2718058 (UMLS CUI [1,2])
C0013072 (UMLS CUI [1,3])
C0205390 (UMLS CUI [1,4])
Code List
If 'No', indicate the reason for the subject's early termination from the Double-Blind Phase:
CL Item
Adverse event (1)
CL Item
Blind broken by Investigator (2)
CL Item
Lost to follow-up (4)
CL Item
Withdrawal of consent (6)
Specification reason for early termination
Item
If reason for early termination is 'Other,' specify:
text
C2348235 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C2718058 (UMLS CUI [1,3])
Adverse event log line, start date and term
Item
If reason for early termination is 'Adverse Event', choose corresponding AE log line, start date, and term:
text
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C1708728 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C2826302 (UMLS CUI [3,2])
Pregnancy due date
Item
Pregnancy due date
date
C0032961 (UMLS CUI [1,1])
C2825543 (UMLS CUI [1,2])
Randomization code broken
Item
Code breaking: Was randomization code broken?
boolean
C0034656 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Date randomization code was broken
Item
Code breaking: lf randomization code was broken, provide date:
date
C0011008 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
Time randomization code broken
Item
Code breaking: Time randomization code broken
time
C0040223 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
Reason for randomization break
Item
Code breaking: Reason for randomization break
text
C0566251 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
Adverse events
Item
Has subject reported any adverse events?
boolean
C0877248 (UMLS CUI [1])
Specification adverse event
Item
If 'Yes', describe adverse event:
text
C2348235 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Start date, adverse event
Item
If 'Yes', start date of event:
date
C0808070 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
If 'Yes', severity/intensity of adverse event
integer
C1710066 (UMLS CUI [1])
Code List
If 'Yes', severity/intensity of adverse event
Item
Action taken regarding study agent
integer
C3854006 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Code List
Action taken regarding study agent
CL Item
Dose increased (1)
CL Item
Dose not changed (2)
CL Item
Drug interrupted (4)
CL Item
Drug withdrawn (5)
CL Item
Not applicable (6)
Adverse event, concomitant therapy
Item
Concomitant or additional treatment given for this AE?
boolean
C0877248 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
Item
Relation to study agent
integer
C1707479 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
Code List
Relation to study agent
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Recovered/resolved (1)
CL Item
Recovering/resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/resolved with sequelae (4)
Recovery date
Item
If 'Recovered/resolved' (with or without sequelae), specify recovery date:
date
C2004454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Serious adverse event
Item
ls this a serious adverse event?
boolean
C1519255 (UMLS CUI [1])
Age at onset of SAE
Item
If 'Yes', age at onset of SAE
integer
C0001779 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Body weight
Item
If 'Yes', weight:
float
C0005910 (UMLS CUI [1])
Body height
Item
If 'Yes', height:
float
C0005890 (UMLS CUI [1])
Serious adverse event, relation to trial-specific procedure
Item
Was the event related to a trial-specific procedure?
boolean
C3828190 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C2700391 (UMLS CUI [1,3])
Congenital anomaly
Item
Was event a congenital anomaly or birth defect?
boolean
C1519255 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Serious adverse event, persistent or significant disability or incapacity
Item
Did the event result in persistent or significant disability or incapacity?
boolean
C1519255 (UMLS CUI [1,1])
C2347488 (UMLS CUI [1,2])
Serious adverse event, hospitalization
Item
Did the event require hospitalization?
boolean
C1519255 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Serious adverse event
Item
Did the event prolong hospitalization?
boolean
C1519255 (UMLS CUI [1,1])
C3640791 (UMLS CUI [1,2])
Admission date
Item
If event required or prolonged hospitalization, specify admission date:
date
C1302393 (UMLS CUI [1,1])
C2348993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Discharge date
Item
Hospital discharge date
date
C2361123 (UMLS CUI [1,1])
C2348993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Life Threatening Adverse Event
Item
Was the event life threatening?
boolean
C1517874 (UMLS CUI [1])
Death Related to Adverse Event
Item
Did the event result in death?
boolean
C1705232 (UMLS CUI [1])
Date of death
Item
Date of death (if applicable)
date
C1148348 (UMLS CUI [1])
Autopsy performed
Item
Was autopsy performed? (if applicable)
boolean
C0004398 (UMLS CUI [1])
Other medically important condition
Item
Was this an 'Other medically important condition?'
boolean
C2826256 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
Item
Trial design
integer
C1507083 (UMLS CUI [1])
CL Item
Open-label phase of multi-phased trial (1)
CL Item
Blinded phase of multi-phased trial (2)
Randomization number
Item
If 'Blinded,' specify randomization number:
integer
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Blind broken
Item
Was blind broken?
boolean
C0034656 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Clinical drug trial status
Item
Study Agent and Dosing Information: Did the subject receive any study agent?
boolean
C0586510 (UMLS CUI [1])
Item
Study Agent and Dosing Information: Name of study agent
integer
C3854006 (UMLS CUI [1])
Code List
Study Agent and Dosing Information: Name of study agent
CL Item
Paliperidone ER (Open-label) (1)
CL Item
PP 1-month injectable (Open-label) (2)
CL Item
PP 1-month injectable OR PP 3-month injectable/placebo (Double-blind) (3)
Date of first dose of study agent
Item
Date of first dose of study agent
date
C0011008 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
Date of most recent dose of study agent
Item
Date of most recent dose of study agent
date
C0011008 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C1513491 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
Lot number
Item
Batch/lot no.
integer
C1115660 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Medication kit number
Item
Medication kit number
integer
C2981406 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Dosage
Item
Dose
integer
C0178602 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Item
Dose unit
integer
C3854006 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Item
Dose frequency
integer
C2982514 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Item
Route
integer
C0013153 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Concomitant therapy
Item
Was the subject taking any drug/therapy 90 days prior to the first dose of study drug and/or during the trial?
boolean
C1707479 (UMLS CUI [1])
Specification concomitant agent
Item
If 'Yes', name of generic drug, medication or therapy:
text
C2348235 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Dosage concomitant agent
Item
Dose amount or range
integer
C0178602 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Dose units
integer
C2347852 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
CL Item
mg (Milligram) (1)
CL Item
mcg (Microgram) (2)
CL Item
mL (Milliliter) (5)
CL Item
meq (Milliequivalent) (7)
CL Item
mcL (Micro Liter) (16)
Item
Route of administration
integer
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Route of administration
CL Item
Intra-abdominal (1)
CL Item
Intra-articular (2)
CL Item
Intralesional (3)
CL Item
Intramuscular (4)
CL Item
Intravenous bolus (6)
CL Item
Intravenous drip (7)
CL Item
Respiratory (Inhalation) (13)
CL Item
Subcutaneous (14)
Item
Frequency
integer
C2347852 (UMLS CUI [1,1])
C2982514 (UMLS CUI [1,2])
CL Item
2XAM (Twice in the morning) (1)
CL Item
2XPM (Twice in the evening) (2)
CL Item
AC (Before meals) (3)
CL Item
BID (Twice daily) (4)
CL Item
BIW (Twice a week) (5)
CL Item
CONT (Continuous) (6)
CL Item
FID (Five times daily) (8)
CL Item
HS (At bedtime) (9)
CL Item
ONCE (One time intervention) (11)
CL Item
PC (After meals) (13)
CL Item
PCA (Patient controlled analgesia) (14)
CL Item
PRN (As needed) (15)
CL Item
Q10H (Every 10 hours) (16)
CL Item
Q11H (Every 11 hours) (17)
CL Item
Q1-2H (Every 1 to 2 hours) (18)
CL Item
Q12H (Every 12 hours) (19)
CL Item
Q4W (Every 4 weeks) (20)
CL Item
QAM (In the morning) (21)
CL Item
QD (Every day) (22)
CL Item
QH (Every hour) (23)
CL Item
QID (Four times daily) (24)
CL Item
QIW (Four time a week) (25)
CL Item
QOD (Every other day) (26)
CL Item
QPM (Every evening) (27)
CL Item
QW (Once weekly) (28)
CL Item
STAT (Immediately) (29)
CL Item
TID (Three times daily) (30)
CL Item
TIW (Three times a week) (31)
CL Item
UNK (Unknown) (32)
Item
Reason therapy administered
integer
C0566251 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
Code List
Reason therapy administered
CL Item
Adverse event (1)
Adverse event log line, start date and term
Item
If reason is 'Adverse event', choose the primary corresponding AE log line, start date, and term:
text
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C1708728 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C2826302 (UMLS CUI [3,2])
Adverse event log line number
Item
If reason is 'Adverse event', choose the primary corresponding AE log line number:
integer
C0877248 (UMLS CUI [1,1])
C1708728 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,3])
Concomitant therapy indication
Item
If reason is 'Other,' describe the indication:
text
C1707479 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Concomitant therapy before trial start
Item
Was the drug/therapy taken prior to the study?
boolean
C1707481 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
Start date of concomitant therapy
Item
Start date of therapy
date
C1707481 (UMLS CUI [1])
Ongoing concomitant therapy
Item
Is the drug/therapy still ongoing?
boolean
C1707479 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
End date of concomitant therapy
Item
End date of therapy
date
C1707480 (UMLS CUI [1])
Item
Indicate the visit to which the comment applies
integer
C0947611 (UMLS CUI [1,1])
C2826704 (UMLS CUI [1,2])
Code List
Indicate the visit to which the comment applies
CL Item
End of Study/Early Withdrawal (22)
CL Item
Unscheduled Visit (24)
CL Item
Subject level (25)
CL Item
Confirmation Visit (26)
CL Item
Not Applicable (27)
Item
Indicate the form to which the comment applies
integer
C0947611 (UMLS CUI [1,1])
C0376315 (UMLS CUI [1,2])
Code List
Indicate the form to which the comment applies
CL Item
Abnormal Involuntary Movement Scale (1)
CL Item
Adverse Events/Serious AEs (2)
CL Item
Barnes Akathisia Rating Scale (3)
CL Item
Clinical Global Impression - Severity (4)
CL Item
Columbia - Suicide Severity Rating Scale (C-SSRS) Baseline (5)
CL Item
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit (6)
CL Item
Concomitant Therapy (7)
CL Item
DNA Sample Consent Modification (11)
CL Item
DNA Sample Replacement (12)
CL Item
Early withdrawal from Open-Label Phase (13)
CL Item
End of Double-Blind Phase/Early withdrawal (14)
CL Item
Evaluation of Relapse (15)
CL Item
Exposure - Open Label Phase (16)
CL Item
Exposure - Double-Blind Phase (17)
CL Item
Inclusion/Exclusion Criteria (18)
CL Item
Investigator Evaluation of Injection site (19)
CL Item
Medical History (20)
CL Item
Mini-Positive and Negative Syndrome Scale for Schizophrenia (21)
CL Item
Nicotine Use (22)
CL Item
Personal and Social Performance Scale (23)
CL Item
Physical Examination (24)
CL Item
Positive and Negative Syndrome Scale for Schizophrenia (25)
CL Item
Pre-Planned Surgery (26)
CL Item
Psychiatric History (27)
CL Item
Randomization (28)
CL Item
Simpson Angus Rating Scale (30)
CL Item
Subject Evaluation of lnjection site (31)
CL Item
Tolerability Testing (32)
CL Item
Urine Dipstick Pregnancy Test (33)
CL Item
Not Applicable (35)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Date of Relapse
Item
Date of Relapse
date
C0035020 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
All subjects who enter this study are required to meet DSM-IV-TR criteria for schizophrenia for at least one year before screening as detailed in the inclusion/exclusion criteria. The DSM-5 diagnostic criteria for schizophrenia have been recently released by the American Psychiatric Association. Based upon this, please select whether or not the subject ALSO meets criteria for a DSM-5 diagnosis of schizophrenia at study entry (i.e. at the time of the Screening visit).
integer
C1137105 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Code List
All subjects who enter this study are required to meet DSM-IV-TR criteria for schizophrenia for at least one year before screening as detailed in the inclusion/exclusion criteria. The DSM-5 diagnostic criteria for schizophrenia have been recently released by the American Psychiatric Association. Based upon this, please select whether or not the subject ALSO meets criteria for a DSM-5 diagnosis of schizophrenia at study entry (i.e. at the time of the Screening visit).
CL Item
YES (The subject meets criteria for DSM-5 diagnosis of schizophrenia at Screening) (1)
CL Item
NO (The subject meets criteria only for DSM-IV diagnosis of schizophrenia at Screening and for at least one year before screening) (2)