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
Versions (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
Description
DNA Sample Consent Modification
Alias
- UMLS CUI-1
- C0021430
- UMLS CUI-2
- C0444245
- UMLS CUI-3
- C3840684
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
Description
Agree to DNA testing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1658606
- UMLS CUI [1,2]
- C3641827
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
Description
Blood sample for DNA testing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1658606
Description
Date sample obtained
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
Description
DNA Sample Replacement
Alias
- UMLS CUI-1
- C0444245
- UMLS CUI-2
- C0559956
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
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
Description
Dermatology Referral
Alias
- UMLS CUI-1
- C0034927
- UMLS CUI-2
- C0011627
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
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
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
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
Description
Early withdrawal from Open-Label Phase
Alias
- UMLS CUI-1
- C2718058
- UMLS CUI-2
- C1709323
- UMLS CUI-3
- C0205390
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
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
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
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
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
Description
Pregnancy due date
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C2825543
Description
End of Double-Blind Phase/Early withdrawal
Alias
- UMLS CUI-1
- C2718058
- UMLS CUI-2
- C0013072
- UMLS CUI-3
- C0205390
Description
Participation in the study per protocol
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C2348563
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
Description
Specification completion of study
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C2348577
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
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
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
Description
Pregnancy due date
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C2825543
Description
Randomization code broken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C3897431
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
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
Description
Reason for randomization break
Data type
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0034656
- UMLS CUI [1,3]
- C3897431
Description
Adverse Events/Serious AEs
Alias
- UMLS CUI-1
- C0877248
Description
Adverse events
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Specification adverse event
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0877248
Description
Start date, adverse event
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0877248
Description
Severity of adverse event
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
Action taken regarding study agent
Data type
integer
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0443172
Description
Adverse event, concomitant therapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1707479
Description
Relation to study agent
Data type
integer
Alias
- UMLS CUI [1,1]
- C1707479
- UMLS CUI [1,2]
- C0687133
- UMLS CUI [1,3]
- C3854006
Description
Outcome adverse event
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Recovery date
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C2004454
- UMLS CUI [1,2]
- C0011008
Description
Serious adverse event
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Age at onset of SAE
Data type
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1519255
Description
Body weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body height
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
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
Description
Congenital anomaly
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0000768
Description
Serious adverse event, persistent or significant disability or incapacity
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347488
Description
Serious adverse event, hospitalization
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1708385
Description
Serious adverse event
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3640791
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
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
Description
Life Threatening Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C1517874
Description
Death Related to Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C1705232
Description
Date of death
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C1148348
Description
Autopsy performed
Data type
boolean
Alias
- UMLS CUI [1]
- C0004398
Description
Other medically important condition
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826256
- UMLS CUI [1,2]
- C0348080
Description
Trial design
Data type
integer
Alias
- UMLS CUI [1]
- C1507083
Description
Randomization number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1300638
- UMLS CUI [1,2]
- C0034656
Description
Blind broken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C3897431
Description
Clinical drug trial status
Data type
boolean
Alias
- UMLS CUI [1]
- C0586510
Description
Name of study agent
Data type
integer
Alias
- UMLS CUI [1]
- C3854006
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
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
Description
Lot number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C3854006
Description
Medication kit number
Data type
integer
Alias
- UMLS CUI [1,1]
- C2981406
- UMLS CUI [1,2]
- C3854006
Description
Dosage
Data type
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C3854006
Description
Dose unit
Data type
integer
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0439148
Description
Dose frequency
Data type
integer
Alias
- UMLS CUI [1,1]
- C2982514
- UMLS CUI [1,2]
- C3854006
Description
Administration route
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C3854006
Description
Concomitant Therapy
Alias
- UMLS CUI-1
- C1707479
Description
Concomitant therapy
Data type
boolean
Alias
- UMLS CUI [1]
- C1707479
Description
Specification concomitant agent
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C2347852
Description
Dosage concomitant agent
Data type
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C2347852
Description
Dose unit concomitant agent
Data type
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0439148
Description
Administration route concomitant agent
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Description
Frequency
Data type
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2982514
Description
Reason concomitant therapy administered
Data type
integer
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C1707479
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
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
Description
Concomitant therapy indication
Data type
text
Alias
- UMLS CUI [1,1]
- C1707479
- UMLS CUI [1,2]
- C3146298
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
Description
Start date of concomitant therapy
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C1707481
Description
Ongoing concomitant therapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1707479
- UMLS CUI [1,2]
- C3174772
Description
End date of concomitant therapy
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C1707480
Description
Comments
Alias
- UMLS CUI-1
- C0947611
Description
Comment, visit name
Data type
integer
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C2826704
Description
Comment, form
Data type
integer
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0376315
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Relapse
Alias
- UMLS CUI-1
- C0035020
Description
DSM-5 Diagnosis
Alias
- UMLS CUI-1
- C1137105
Description
DSM-5 Diagnosis Schizophrenia
Data type
integer
Alias
- UMLS CUI [1,1]
- C1137105
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0036341
Description
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Similar models
Subject level - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
C0444245 (UMLS CUI [1,2])
C0444245 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,2])
C0680575 (UMLS CUI [1,3])
C1698986 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0439234 (UMLS CUI [1,4])
C0444245 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
C0439234 (UMLS CUI [1,4])
C3641827 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,2])
C3641827 (UMLS CUI [1,3])
C1658606 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0444245 (UMLS CUI-2)
C3840684 (UMLS CUI-3)
C0021430 (UMLS CUI [1,2])
C0444245 (UMLS CUI [1,3])
C3840684 (UMLS CUI [1,4])
C3641827 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,2])
C3641827 (UMLS CUI [1,3])
C1658606 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0559956 (UMLS CUI-2)
C1524062 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
C1658606 (UMLS CUI [1,4])
C1524062 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
C1658606 (UMLS CUI [1,4])
C0011627 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0151735 (UMLS CUI [1,4])
C0034927 (UMLS CUI [1,2])
C0011627 (UMLS CUI [1,3])
C0034927 (UMLS CUI [1,2])
C0011627 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C0034927 (UMLS CUI [1,3])
C0011627 (UMLS CUI [1,4])
C1709323 (UMLS CUI-2)
C0205390 (UMLS CUI-3)
C1709323 (UMLS CUI [1,2])
C0205390 (UMLS CUI [1,3])
C2718058 (UMLS CUI [1,2])
C1709323 (UMLS CUI [1,3])
C0205390 (UMLS CUI [1,4])
C3828770 (UMLS CUI [1,2])
C0013072 (UMLS CUI [1,3])
C0205390 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,2])
C2718058 (UMLS CUI [1,3])
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])
C2825543 (UMLS CUI [1,2])
C0013072 (UMLS CUI-2)
C0205390 (UMLS CUI-3)
C2348563 (UMLS CUI [1,2])
C2718058 (UMLS CUI [1,2])
C0013072 (UMLS CUI [1,3])
C0205390 (UMLS CUI [1,4])
C2348577 (UMLS CUI [1,2])
C2718058 (UMLS CUI [1,2])
C0013072 (UMLS CUI [1,3])
C0205390 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,2])
C2718058 (UMLS CUI [1,3])
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])
C2825543 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C1707479 (UMLS CUI [1,2])
C0687133 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C2700391 (UMLS CUI [1,3])
C0000768 (UMLS CUI [1,2])
C2347488 (UMLS CUI [1,2])
C1708385 (UMLS CUI [1,2])
C3640791 (UMLS CUI [1,2])
C2348993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2348993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0348080 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C3854006 (UMLS CUI [1,2])
C1513491 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1707479 (UMLS CUI [1,2])
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])
C1708728 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C2826704 (UMLS CUI [1,2])
C0376315 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])