ID

22270

Description

A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01515423 Sponsor: Janssen Research & Development, LLC Other drug name: TREVICTA®

Link

https://clinicaltrials.gov/ct2/show/NCT01515423

Keywords

  1. 5/28/17 5/28/17 -
Uploaded on

May 28, 2017

DOI

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License

Creative Commons BY 4.0

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Subject level - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Subject level - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

DNA Sample
Description

DNA Sample

Alias
UMLS CUI-1
C0444245
Did the subject sign a DNA informed consent form?
Description

Informed consent, DNA Sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0444245
lf 'Yes,' provide date of signature:
Description

Date of informed consent, DNA Sample

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C2985782
UMLS CUI [1,2]
C0444245
dd.mm.yyyy
Did local or country regulations limit the length of storage for this subject's DNA sample?
Description

Deoxyribonucleic acid sample; Storage; legal regulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0444245
UMLS CUI [1,2]
C1698986
UMLS CUI [1,3]
C0680575
If 'Yes', specify the storage limit:
Description

DNA Sample Storage limit

Data type

integer

Alias
UMLS CUI [1,1]
C0444245
UMLS CUI [1,2]
C1698986
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0439234
If storage limit is 'Other', specify the number of years the sample may be stored:
Description

Specification DNA Sample Storage limit

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0444245
UMLS CUI [1,3]
C1698986
UMLS CUI [1,4]
C0439234
years
Did the subject agree to study-specific DNA testing? (Part 1)
Description

Agree to DNA testing

Data type

boolean

Alias
UMLS CUI [1,1]
C1658606
UMLS CUI [1,2]
C3641827
Did the subject agree to DNA sample storage for future testing? (Part 2)
Description

Agree to DNA sample storage

Data type

boolean

Alias
UMLS CUI [1,1]
C0444245
UMLS CUI [1,2]
C1698986
UMLS CUI [1,3]
C3641827
Was a blood sample for DNA testing obtained?
Description

Blood sample for DNA testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1658606
Date sample obtained
Description

Date sample obtained

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
dd.mm.yyyy
DNA Sample Consent Modification
Description

DNA Sample Consent Modification

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0444245
UMLS CUI-3
C3840684
Date of signature on DNA informed consent form modifying original decision regarding DNA sampling/storage
Description

Date of DNA informed consent form modifying original decision

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0444245
UMLS CUI [1,4]
C3840684
dd.mm.yyyy
Does the subject agree to study-specific DNA testing at this time? (Part 1)
Description

Agree to DNA testing

Data type

boolean

Alias
UMLS CUI [1,1]
C1658606
UMLS CUI [1,2]
C3641827
Does the subject agree to DNA sample storage for future testing at this time? (Part 2)
Description

Agree to DNA Sample Storage

Data type

boolean

Alias
UMLS CUI [1,1]
C0444245
UMLS CUI [1,2]
C1698986
UMLS CUI [1,3]
C3641827
Was a blood sample for DNA testing obtained?
Description

Blood sample for DNA testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1658606
Date sample obtained
Description

Date sample obtained

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
dd.mm.yyyy
DNA Sample Replacement
Description

DNA Sample Replacement

Alias
UMLS CUI-1
C0444245
UMLS CUI-2
C0559956
Date of additional blood sample for DNA testing
Description

Date of additional blood sample for DNA testing

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0005834
UMLS CUI [1,4]
C1658606
dd.mm.yyyy
Reason for additional sample
Description

Reason for additional sample

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0005834
UMLS CUI [1,4]
C1658606
Dermatology Referral
Description

Dermatology Referral

Alias
UMLS CUI-1
C0034927
UMLS CUI-2
C0011627
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)?
Description

Subject referred to a dermatologist for the evaluation of an injection site reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C0034927
UMLS CUI [1,2]
C0011627
UMLS CUI [1,3]
C0220825
UMLS CUI [1,4]
C0151735
Date of referral
Description

Date of referral to dermatologist

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0034927
UMLS CUI [1,3]
C0011627
dd.mm.yyyy
Reason for referral
Description

Reason for referral to dermatologist

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0034927
UMLS CUI [1,3]
C0011627
If 'Other', specify:
Description

Specification reason for referral

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0034927
UMLS CUI [1,4]
C0011627
Early withdrawal from Open-Label Phase
Description

Early withdrawal from Open-Label Phase

Alias
UMLS CUI-1
C2718058
UMLS CUI-2
C1709323
UMLS CUI-3
C0205390
Date of withdrawal from Open Label Phase
Description

Date of withdrawal from Open Label Phase

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C4284321
UMLS CUI [1,2]
C1709323
UMLS CUI [1,3]
C0205390
dd.mm.yyyy
Reason for early withdrawal from Open Label Phase
Description

Reason for early withdrawal from Open Label Phase

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2718058
UMLS CUI [1,3]
C1709323
UMLS CUI [1,4]
C0205390
If Subject failed to meet criteria to enter the Double-Blind phase, please specify:
Description

Specification, Failed meeting criteria to enter Double-Blind phase

Data type

integer

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C3828770
UMLS CUI [1,3]
C0013072
UMLS CUI [1,4]
C0205390
If reason for early termination is 'Other,' specify:
Description

Specification reason for early termination

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C2718058
If reason is 'Adverse Event,' specify corresponding AE log line, start date, and term:
Description

Adverse event log line, start date and term

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1708728
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C2826302
Pregnancy due date
Description

Pregnancy due date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2825543
dd.mm.yyyy
End of Double-Blind Phase/Early withdrawal
Description

End of Double-Blind Phase/Early withdrawal

Alias
UMLS CUI-1
C2718058
UMLS CUI-2
C0013072
UMLS CUI-3
C0205390
Did the subject complete participation in the study per protocol?
Description

Participation in the study per protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C2348563
Date of completion or early termination from the Double-Blind Phase
Description

Date of completion or early termination from the Double-Blind Phase

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2718058
UMLS CUI [1,3]
C0013072
UMLS CUI [1,4]
C0205390
dd.mm.yyyy
If 'Yes', indicate category:
Description

Specification completion of study

Data type

integer

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C2348577
If 'No', indicate the reason for the subject's early termination from the Double-Blind Phase:
Description

Reason for early termination from the Double-Blind Phase

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2718058
UMLS CUI [1,3]
C0013072
UMLS CUI [1,4]
C0205390
If reason for early termination is 'Other,' specify:
Description

Specification reason for early termination

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C2718058
If reason for early termination is 'Adverse Event', choose corresponding AE log line, start date, and term:
Description

Adverse event log line, start date and term

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1708728
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C2826302
Pregnancy due date
Description

Pregnancy due date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2825543
dd.mm.yyyy
Code breaking: Was randomization code broken?
Description

Randomization code broken

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C3897431
Code breaking: lf randomization code was broken, provide date:
Description

Date randomization code was broken

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C3897431
dd.mm.yyyy
Code breaking: Time randomization code broken
Description

Time randomization code broken

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C3897431
hh:mm
Code breaking: Reason for randomization break
Description

Reason for randomization break

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C3897431
Adverse Events/Serious AEs
Description

Adverse Events/Serious AEs

Alias
UMLS CUI-1
C0877248
Has subject reported any adverse events?
Description

Adverse events

Data type

boolean

Alias
UMLS CUI [1]
C0877248
If 'Yes', describe adverse event:
Description

Specification adverse event

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0877248
If 'Yes', start date of event:
Description

Start date, adverse event

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0877248
dd.mm.yyyy
If 'Yes', severity/intensity of adverse event
Description

Severity of adverse event

Data type

integer

Alias
UMLS CUI [1]
C1710066
Action taken regarding study agent
Description

Action taken regarding study agent

Data type

integer

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0443172
Concomitant or additional treatment given for this AE?
Description

Adverse event, concomitant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1707479
Relation to study agent
Description

Relation to study agent

Data type

integer

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C3854006
Outcome
Description

Outcome adverse event

Data type

integer

Alias
UMLS CUI [1]
C1705586
If 'Recovered/resolved' (with or without sequelae), specify recovery date:
Description

Recovery date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C2004454
UMLS CUI [1,2]
C0011008
dd.mm.yyyy
ls this a serious adverse event?
Description

Serious adverse event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
If 'Yes', age at onset of SAE
Description

Age at onset of SAE

Data type

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1519255
If 'Yes', weight:
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
If 'Yes', height:
Description

Body height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Was the event related to a trial-specific procedure?
Description

Serious adverse event, relation to trial-specific procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C3828190
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C2700391
Was event a congenital anomaly or birth defect?
Description

Congenital anomaly

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0000768
Did the event result in persistent or significant disability or incapacity?
Description

Serious adverse event, persistent or significant disability or incapacity

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347488
Did the event require hospitalization?
Description

Serious adverse event, hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1708385
Did the event prolong hospitalization?
Description

Serious adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3640791
If event required or prolonged hospitalization, specify admission date:
Description

Admission date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C1302393
UMLS CUI [1,2]
C2348993
UMLS CUI [1,3]
C1519255
dd.mm.yyyy
Hospital discharge date
Description

Discharge date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C2361123
UMLS CUI [1,2]
C2348993
UMLS CUI [1,3]
C1519255
dd.mm.yyyy
Was the event life threatening?
Description

Life Threatening Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1517874
Did the event result in death?
Description

Death Related to Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1705232
Date of death (if applicable)
Description

Date of death

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1148348
dd.mm.yyyy
Was autopsy performed? (if applicable)
Description

Autopsy performed

Data type

boolean

Alias
UMLS CUI [1]
C0004398
Was this an 'Other medically important condition?'
Description

Other medically important condition

Data type

boolean

Alias
UMLS CUI [1,1]
C2826256
UMLS CUI [1,2]
C0348080
Trial design
Description

Trial design

Data type

integer

Alias
UMLS CUI [1]
C1507083
If 'Blinded,' specify randomization number:
Description

Randomization number

Data type

integer

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0034656
Was blind broken?
Description

Blind broken

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C3897431
Study Agent and Dosing Information: Did the subject receive any study agent?
Description

Clinical drug trial status

Data type

boolean

Alias
UMLS CUI [1]
C0586510
Study Agent and Dosing Information: Name of study agent
Description

Name of study agent

Data type

integer

Alias
UMLS CUI [1]
C3854006
Date of first dose of study agent
Description

Date of first dose of study agent

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3854006
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0178602
dd.mm.yyyy
Date of most recent dose of study agent
Description

Date of most recent dose of study agent

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3854006
UMLS CUI [1,3]
C1513491
UMLS CUI [1,4]
C0178602
dd.mm.yyyy
Batch/lot no.
Description

Lot number

Data type

integer

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C3854006
Medication kit number
Description

Medication kit number

Data type

integer

Alias
UMLS CUI [1,1]
C2981406
UMLS CUI [1,2]
C3854006
Dose
Description

Dosage

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C3854006
Dose unit
Description

Dose unit

Data type

integer

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439148
Dose frequency
Description

Dose frequency

Data type

integer

Alias
UMLS CUI [1,1]
C2982514
UMLS CUI [1,2]
C3854006
Route
Description

Administration route

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C3854006
Concomitant Therapy
Description

Concomitant Therapy

Alias
UMLS CUI-1
C1707479
Was the subject taking any drug/therapy 90 days prior to the first dose of study drug and/or during the trial?
Description

Concomitant therapy

Data type

boolean

Alias
UMLS CUI [1]
C1707479
If 'Yes', name of generic drug, medication or therapy:
Description

Specification concomitant agent

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C2347852
Dose amount or range
Description

Dosage concomitant agent

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C2347852
Dose units
Description

Dose unit concomitant agent

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439148
Route of administration
Description

Administration route concomitant agent

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Frequency
Description

Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2982514
Reason therapy administered
Description

Reason concomitant therapy administered

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1707479
If reason is 'Adverse event', choose the primary corresponding AE log line, start date, and term:
Description

Adverse event log line, start date and term

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1708728
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C2826302
If reason is 'Adverse event', choose the primary corresponding AE log line number:
Description

Adverse event log line number

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1708728
UMLS CUI [1,3]
C1300638
If reason is 'Other,' describe the indication:
Description

Concomitant therapy indication

Data type

text

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C3146298
Was the drug/therapy taken prior to the study?
Description

Concomitant therapy before trial start

Data type

boolean

Alias
UMLS CUI [1,1]
C1707481
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2348558
Start date of therapy
Description

Start date of concomitant therapy

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1707481
dd.mm.yyyy
Is the drug/therapy still ongoing?
Description

Ongoing concomitant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C3174772
End date of therapy
Description

End date of concomitant therapy

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1707480
dd.mm.yyyy
Comments
Description

Comments

Alias
UMLS CUI-1
C0947611
Indicate the visit to which the comment applies
Description

Comment, visit name

Data type

integer

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2826704
Indicate the form to which the comment applies
Description

Comment, form

Data type

integer

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0376315
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Relapse
Description

Relapse

Alias
UMLS CUI-1
C0035020
Date of Relapse
Description

Date of Relapse

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0011008
dd.mm.yyyy
DSM-5 Diagnosis
Description

DSM-5 Diagnosis

Alias
UMLS CUI-1
C1137105
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).
Description

DSM-5 Diagnosis Schizophrenia

Data type

integer

Alias
UMLS CUI [1,1]
C1137105
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0036341
Subject Identification
Description

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject identifier
Description

Subject identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585

Similar models

Subject level - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
DNA Sample
C0444245 (UMLS CUI-1)
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:
CL Item
3 years (1)
CL Item
5 years (2)
CL Item
10 years (3)
CL Item
15 years (4)
CL Item
20 years (5)
CL Item
Other (6)
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])
Item Group
DNA Sample Consent Modification
C0021430 (UMLS CUI-1)
C0444245 (UMLS CUI-2)
C3840684 (UMLS CUI-3)
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])
Item Group
DNA Sample Replacement
C0444245 (UMLS CUI-1)
C0559956 (UMLS CUI-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])
Item Group
Dermatology Referral
C0034927 (UMLS CUI-1)
C0011627 (UMLS CUI-2)
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)
CL Item
Other (4)
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])
Item Group
Early withdrawal from Open-Label Phase
C2718058 (UMLS CUI-1)
C1709323 (UMLS CUI-2)
C0205390 (UMLS CUI-3)
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
Death (2)
CL Item
Lack of efficacy (3)
CL Item
Lost to follow-up (4)
CL Item
Screen failure (5)
CL Item
Pregnancy (6)
CL Item
Withdrawal of consent (7)
CL Item
Subject failed to meet randomization criteria to enter the Double-Blind phase  (8)
CL Item
Other (9)
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])
Item Group
End of Double-Blind Phase/Early withdrawal
C2718058 (UMLS CUI-1)
C0013072 (UMLS CUI-2)
C0205390 (UMLS CUI-3)
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
Death (3)
CL Item
Lost to follow-up (4)
CL Item
Pregnancy (5)
CL Item
Withdrawal of consent (6)
CL Item
Other (7)
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])
Item Group
Adverse Events/Serious AEs
C0877248 (UMLS CUI-1)
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
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
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
Dose reduced (3)
CL Item
Drug interrupted (4)
CL Item
Drug withdrawn (5)
CL Item
Not applicable (6)
CL Item
Unknown (7)
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
CL Item
Not related (1)
CL Item
Doubtful (2)
CL Item
Possible (3)
CL Item
Probable (4)
CL Item
Very likely (5)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Code List
Outcome
CL Item
Recovered/resolved (1)
CL Item
Recovering/resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/resolved with sequelae (4)
CL Item
Fatal (5)
CL Item
Unknown (6)
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])
Code List
Trial design
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])
Code List
Dose unit
CL Item
mg (1)
CL Item
mg eq (2)
Item
Dose frequency
integer
C2982514 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Code List
Dose frequency
CL Item
Daily (1)
CL Item
Monthly (2)
Item
Route
integer
C0013153 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Code List
Route
CL Item
i.m. (1)
CL Item
Oral (2)
Item Group
Concomitant Therapy
C1707479 (UMLS CUI-1)
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])
Code List
Dose units
CL Item
mg (Milligram) (1)
CL Item
mcg (Microgram) (2)
CL Item
g (Gram) (3)
CL Item
Tablet (4)
CL Item
mL (Milliliter) (5)
CL Item
Puff (6)
CL Item
meq (Milliequivalent) (7)
CL Item
Capsule (8)
CL Item
Pill (9)
CL Item
Drops (10)
CL Item
Ointment (11)
CL Item
Tablespoon (12)
CL Item
Teaspoon (13)
CL Item
L (Liter) (14)
CL Item
Patch (15)
CL Item
mcL (Micro Liter) (16)
CL Item
Other (17)
CL Item
Units (18)
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 (5)
CL Item
Intravenous bolus (6)
CL Item
Intravenous drip (7)
CL Item
Nasal (8)
CL Item
Nasogastric (9)
CL Item
Ophthalmic (10)
CL Item
Oral (11)
CL Item
Rectal (12)
CL Item
Respiratory (Inhalation) (13)
CL Item
Subcutaneous (14)
CL Item
Sublingual (15)
CL Item
Topical (16)
CL Item
Transdermal (17)
CL Item
Unknown (18)
CL Item
Other (19)
Item
Frequency
integer
C2347852 (UMLS CUI [1,1])
C2982514 (UMLS CUI [1,2])
Code List
Frequency
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
DAILY (7)
CL Item
FID (Five times daily) (8)
CL Item
HS (At bedtime) (9)
CL Item
MONTHLY (10)
CL Item
ONCE (One time intervention) (11)
CL Item
Other (12)
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)
CL Item
Other (2)
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 Group
Comments
C0947611 (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
Screening (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
CL Item
Visit 7 (7)
CL Item
Visit 8 (8)
CL Item
Visit 9 (9)
CL Item
Visit 10 (10)
CL Item
Visit 11 (11)
CL Item
Visit 12 (12)
CL Item
Visit 13 (13)
CL Item
Visit 14 (14)
CL Item
Visit 15 (15)
CL Item
Visit 16 (16)
CL Item
Visit 17 (17)
CL Item
Visit 18 (18)
CL Item
Visit 19 (19)
CL Item
Visit 20 (20)
CL Item
Visit 21 (21)
CL Item
End of Study/Early Withdrawal (22)
CL Item
Follow Up (23)
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
Demographics (8)
CL Item
Diagnosis (9)
CL Item
DNA Sample (10)
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
Relapse (29)
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
Vital Signs (34)
CL Item
Not Applicable (35)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Relapse
C0035020 (UMLS CUI-1)
Date of Relapse
Item
Date of Relapse
date
C0035020 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
DSM-5 Diagnosis
C1137105 (UMLS CUI-1)
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)
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
integer
C2348585 (UMLS CUI [1])

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