ID
22188
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)
- 5/22/17 5/22/17 -
Uploaded on
May 22, 2017
DOI
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License
Creative Commons BY 4.0
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Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
- StudyEvent: ODM
Description
Vital Signs Pulse and Blood Pressure
Alias
- UMLS CUI-1
- C0518766
Description
Pulse at rest
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0232117
- UMLS CUI [1,2]
- C0443144
Description
SBP at rest
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C2039694
Description
DBP at rest
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C2183311
Description
Pulse while standing
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C2029905
Description
SBP standing
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C1303018
Description
DBP standing
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C1303019
Description
Patient position finding
Data type
integer
Alias
- UMLS CUI [1]
- C0449850
Description
PK Blood Sample: Paliperidone
Alias
- UMLS CUI-1
- C0201734
- UMLS CUI-2
- C0178913
- UMLS CUI-3
- C0753678
Description
Specimen taken
Data type
boolean
Alias
- UMLS CUI [1]
- C1277698
Description
Accession number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1510755
- UMLS CUI [1,2]
- C2826726
Description
Comment, blood specimen
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0178913
Description
Positive and Negative Syndrome Scale for Schizophrenia
Alias
- UMLS CUI-1
- C4086747
- UMLS CUI-2
- C0036341
Description
Rater's initials
Data type
text
Alias
- UMLS CUI [1]
- C3166278
Description
PANSS: Delusions
Data type
integer
Alias
- UMLS CUI [1]
- C4087066
Description
PANSS: Conceptual disorganization
Data type
integer
Alias
- UMLS CUI [1]
- C4086687
Description
PANSS: Hallucinatory behavior
Data type
integer
Alias
- UMLS CUI [1]
- C4086696
Description
PANSS: Excitement
Data type
integer
Alias
- UMLS CUI [1]
- C4086693
Description
PANSS: Grandiosity
Data type
integer
Alias
- UMLS CUI [1]
- C4086694
Description
PANSS: Suspiciousness/persecution
Data type
integer
Alias
- UMLS CUI [1]
- C4087067
Description
PANSS: Hostility
Data type
integer
Alias
- UMLS CUI [1]
- C4086697
Description
PANSS: Blunted affect
Data type
integer
Alias
- UMLS CUI [1]
- C4086686
Description
PANSS: Emotional withdrawal
Data type
integer
Alias
- UMLS CUI [1]
- C4086692
Description
PANSS: Poor rapport
Data type
integer
Alias
- UMLS CUI [1]
- C4086705
Description
PANSS: Passive/apathetic social withdrawal
Data type
integer
Alias
- UMLS CUI [1]
- C4086702
Description
PANSS: Difficulty in abstract thinking
Data type
integer
Alias
- UMLS CUI [1]
- C4086689
Description
PANSS: Lack of spontaneity and flow of conversation
Data type
integer
Alias
- UMLS CUI [1]
- C4086699
Description
PANSS: Stereotyped thinking
Data type
integer
Alias
- UMLS CUI [1]
- C4086708
Description
PANSS: Somatic concern
Data type
integer
Alias
- UMLS CUI [1]
- C4086707
Description
PANSS: Anxiety
Data type
integer
Alias
- UMLS CUI [1]
- C4086685
Description
PANSS: Guilt feelings
Data type
integer
Alias
- UMLS CUI [1]
- C4086695
Description
PANSS: Tension
Data type
integer
Alias
- UMLS CUI [1]
- C4086709
Description
PANSS: Mannerisms and posturing
Data type
integer
Alias
- UMLS CUI [1]
- C4086700
Description
PANSS: Depression
Data type
integer
Alias
- UMLS CUI [1]
- C4086688
Description
PANSS: Motor retardation
Data type
integer
Alias
- UMLS CUI [1]
- C4086701
Description
PANSS: Uncooperativeness
Data type
integer
Alias
- UMLS CUI [1]
- C4086710
Description
PANSS: Unusual thought content
Data type
integer
Alias
- UMLS CUI [1]
- C4086711
Description
PANSS: Disorientation
Data type
integer
Alias
- UMLS CUI [1]
- C4086690
Description
PANSS: Poor attention
Data type
integer
Alias
- UMLS CUI [1]
- C4086703
Description
PANSS: Lack of judgment and insight
Data type
integer
Alias
- UMLS CUI [1]
- C4086698
Description
PANSS: Disturbance of volition
Data type
integer
Alias
- UMLS CUI [1]
- C4086691
Description
PANSS: Poor impulse control
Data type
integer
Alias
- UMLS CUI [1]
- C4086704
Description
PANSS: Preoccupation
Data type
integer
Alias
- UMLS CUI [1]
- C4086706
Description
PANSS: Active social avoidence
Data type
integer
Alias
- UMLS CUI [1]
- C4086684
Description
Calculated total PANSS score
Data type
integer
Alias
- UMLS CUI [1,1]
- C4086747
- UMLS CUI [1,2]
- C0449820
Description
Clinical Global Impression - Severity
Alias
- UMLS CUI-1
- C3639708
Description
Rater´s initials
Data type
text
Alias
- UMLS CUI [1]
- C3166278
Description
Clinical global impression of subject's psychotic disorder
Data type
integer
Alias
- UMLS CUI [1]
- C3698629
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Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
- StudyEvent: ODM
C0443144 (UMLS CUI [1,2])
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C0753678 (UMLS CUI-3)
C2826726 (UMLS CUI [1,2])
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C0036341 (UMLS CUI-2)
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