ID
22189
Beskrivning
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®
Länk
https://clinicaltrials.gov/ct2/show/NCT01515423
Nyckelord
Versioner (2)
- 2017-05-22 2017-05-22 -
- 2017-05-22 2017-05-22 -
Uppladdad den
22 maj 2017
DOI
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Licens
Creative Commons BY 4.0
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Visit 6 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
Visit 6 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
- StudyEvent: ODM
Beskrivning
Vital Signs Pulse and Blood Pressure
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Pulse at rest
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1,1]
- C0232117
- UMLS CUI [1,2]
- C0443144
Beskrivning
SBP at rest
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C2039694
Beskrivning
DBP at rest
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C2183311
Beskrivning
Pulse while standing
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C2029905
Beskrivning
SBP standing
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C1303018
Beskrivning
DBP standing
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C1303019
Beskrivning
Patient position finding
Datatyp
integer
Alias
- UMLS CUI [1]
- C0449850
Beskrivning
PK Blood Sample: Paliperidone
Alias
- UMLS CUI-1
- C0201734
- UMLS CUI-2
- C0178913
- UMLS CUI-3
- C0753678
Beskrivning
Specimen taken
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1277698
Beskrivning
Accession number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1510755
- UMLS CUI [1,2]
- C2826726
Beskrivning
Comment, blood specimen
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0178913
Beskrivning
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version
Alias
- UMLS CUI-1
- C3641328
Beskrivning
SSRS: Wish to be dead
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641578
Beskrivning
SSRS: Description of wish to be dead
Datatyp
text
Alias
- UMLS CUI [1]
- C3641579
Beskrivning
SSRS: Non-specific active suicidal thoughts
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641580
Beskrivning
SSRS: Description of Non-Specific Active Suicidal Thoughts
Datatyp
text
Alias
- UMLS CUI [1]
- C3641581
Beskrivning
SSRS: Active suicidal ideation with any methods (not plan) without intent to act
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641582
Beskrivning
SSRS: Description of Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Datatyp
text
Alias
- UMLS CUI [1]
- C3641583
Beskrivning
SSRS: Active suicidal ideation with some intent to act, without specific plan
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641605
Beskrivning
SSRS: Description of Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Datatyp
text
Alias
- UMLS CUI [1]
- C3641606
Beskrivning
SSRS: Active suicidal ideation with specific plan and intent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641607
Beskrivning
SSRS: Description of Active Suicidal Ideation with Specific Plan and Intent
Datatyp
text
Alias
- UMLS CUI [1]
- C3641584
Beskrivning
SSRS: Most Severe Ideation
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641585
Beskrivning
SSRS: Description of Ideation
Datatyp
text
Alias
- UMLS CUI [1]
- C3641586
Beskrivning
SSRS: Frequency
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641587
Beskrivning
SSRS: Duration
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641588
Beskrivning
SSRS: Controllability
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641589
Beskrivning
SSRS: Deterrents
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641590
Beskrivning
SSRS: Reasons for ideation
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641591
Beskrivning
SSRS: Actual Suicide Attempt
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641592
Beskrivning
SSRS: Number of Actual Suicide Attempts
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641593
Beskrivning
SSRS: Description of Actual Suicide Attempts
Datatyp
text
Alias
- UMLS CUI [1]
- C3641594
Beskrivning
SSRS: Non-suicidal self-injurious behavior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641595
Beskrivning
SSRS: Interrupted Suicide Attempt
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641596
Beskrivning
SSRS: Number of Interrupted Suicide Attempts
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641597
Beskrivning
SSRS: Description of Interrupted Suicide Attempts
Datatyp
text
Alias
- UMLS CUI [1]
- C3641598
Beskrivning
SSRS: Aborted Suicide Attempt
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641599
Beskrivning
SSRS: Number of Aborted Suicide Attempts
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641600
Beskrivning
SSRS: Description of Aborted Suicide Attempt
Datatyp
text
Alias
- UMLS CUI [1]
- C3641601
Beskrivning
SSRS: Preparatory Acts or Behaviors Toward Suicide Attempt
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641602
Beskrivning
SSRS: Description of Preparatory Acts or Behaviors Toward Suicide Attempt
Datatyp
text
Alias
- UMLS CUI [1]
- C3641603
Beskrivning
SSRS: Suicidal Behavior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641604
Beskrivning
SSRS: Completed suicide
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641338
Beskrivning
SSRS: Most Lethal Suicide Attempt Date
Datatyp
date
Måttenheter
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C3641339
Beskrivning
SSRS: Most Lethal Suicide Attempt Damage
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641340
Beskrivning
SSRS: Most Lethal Suicide Attempt Potential
Datatyp
integer
Alias
- UMLS CUI [1]
- C3641341
Beskrivning
Investigator Evaluation of lnjection site
Alias
- UMLS CUI-1
- C0035173
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C2700396
Beskrivning
Rater's initials
Datatyp
text
Alias
- UMLS CUI [1]
- C3166278
Beskrivning
Time of evaluation
Datatyp
time
Måttenheter
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C2700396
Beskrivning
Redness of injection site
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C2700396
Beskrivning
Swelling of injection site
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C2700396
Beskrivning
Induration of injection site
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0332534
- UMLS CUI [1,2]
- C2700396
Beskrivning
Subject Evaluation of lnjection site
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C2700396
Beskrivning
Positive and Negative Syndrome Scale for Schizophrenia
Alias
- UMLS CUI-1
- C4086747
- UMLS CUI-2
- C0036341
Beskrivning
Rater's initials
Datatyp
text
Alias
- UMLS CUI [1]
- C3166278
Beskrivning
PANSS: Delusions
Datatyp
integer
Alias
- UMLS CUI [1]
- C4087066
Beskrivning
PANSS: Conceptual disorganization
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086687
Beskrivning
PANSS: Hallucinatory behavior
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086696
Beskrivning
PANSS: Excitement
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086693
Beskrivning
PANSS: Grandiosity
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086694
Beskrivning
PANSS: Suspiciousness/persecution
Datatyp
integer
Alias
- UMLS CUI [1]
- C4087067
Beskrivning
PANSS: Hostility
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086697
Beskrivning
PANSS: Blunted affect
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086686
Beskrivning
PANSS: Emotional withdrawal
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086692
Beskrivning
PANSS: Poor rapport
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086705
Beskrivning
PANSS: Passive/apathetic social withdrawal
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086702
Beskrivning
PANSS: Difficulty in abstract thinking
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086689
Beskrivning
PANSS: Lack of spontaneity and flow of conversation
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086699
Beskrivning
PANSS: Stereotyped thinking
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086708
Beskrivning
PANSS: Somatic concern
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086707
Beskrivning
PANSS: Anxiety
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086685
Beskrivning
PANSS: Guilt feelings
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086695
Beskrivning
PANSS: Tension
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086709
Beskrivning
PANSS: Mannerisms and posturing
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086700
Beskrivning
PANSS: Depression
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086688
Beskrivning
PANSS: Motor retardation
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086701
Beskrivning
PANSS: Uncooperativeness
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086710
Beskrivning
PANSS: Unusual thought content
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086711
Beskrivning
PANSS: Disorientation
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086690
Beskrivning
PANSS: Poor attention
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086703
Beskrivning
PANSS: Lack of judgment and insight
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086698
Beskrivning
PANSS: Disturbance of volition
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086691
Beskrivning
PANSS: Poor impulse control
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086704
Beskrivning
PANSS: Preoccupation
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086706
Beskrivning
PANSS: Active social avoidence
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086684
Beskrivning
Calculated total PANSS score
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C4086747
- UMLS CUI [1,2]
- C0449820
Beskrivning
Clinical Global Impression - Severity
Alias
- UMLS CUI-1
- C3639708
Beskrivning
Rater´s initials
Datatyp
text
Alias
- UMLS CUI [1]
- C3166278
Beskrivning
Clinical global impression of subject's psychotic disorder
Datatyp
integer
Alias
- UMLS CUI [1]
- C3698629
Beskrivning
Administration of trial medication
Alias
- UMLS CUI-1
- C3854006
- UMLS CUI-2
- C3469597
Beskrivning
Medication Kit Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2981406
- UMLS CUI [1,2]
- C3854006
Beskrivning
Dispensation Date
Datatyp
date
Måttenheter
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826773
Beskrivning
Study drug administrator's initials
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C3854006
Beskrivning
Date of injection
Datatyp
date
Måttenheter
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021485
Beskrivning
Actual clock time of injection
Datatyp
time
Måttenheter
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0021485
Beskrivning
Injection site
Datatyp
integer
Alias
- UMLS CUI [1]
- C2700396
Beskrivning
Medication Kit Dispensation
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1880359
- UMLS CUI-3
- C1690540
Beskrivning
Date medication kit assigned
Datatyp
date
Måttenheter
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1516050
- UMLS CUI [1,3]
- C3854006
- UMLS CUI [1,4]
- C1690540
Beskrivning
Medication kit number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2981406
- UMLS CUI [1,2]
- C3854006
Similar models
Visit 6 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
- StudyEvent: ODM
C0443144 (UMLS CUI [1,2])
C0178913 (UMLS CUI-2)
C0753678 (UMLS CUI-3)
C2826726 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0036341 (UMLS CUI-2)
C0449820 (UMLS CUI [1,2])
C3469597 (UMLS CUI-2)
C3854006 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,2])
C0021485 (UMLS CUI [1,2])
C1880359 (UMLS CUI-2)
C1690540 (UMLS CUI-3)
C1516050 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
C1690540 (UMLS CUI [1,4])
C3854006 (UMLS CUI [1,2])