ID
22186
Beschreibung
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
Stichworte
Versionen (1)
- 22.05.17 22.05.17 -
Hochgeladen am
22. Mai 2017
DOI
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Lizenz
Creative Commons BY 4.0
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Visit 5 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
Visit 5 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
- StudyEvent: ODM
Beschreibung
ECG
Alias
- UMLS CUI-1
- C1623258
Beschreibung
Vital Signs Pulse and Blood Pressure
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Pulse at rest
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0232117
- UMLS CUI [1,2]
- C0443144
Beschreibung
SBP at rest
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C2039694
Beschreibung
DBP at rest
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C2183311
Beschreibung
Pulse while standing
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C2029905
Beschreibung
SBP standing
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C1303018
Beschreibung
DBP standing
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C1303019
Beschreibung
Patient position finding
Datentyp
integer
Alias
- UMLS CUI [1]
- C0449850
Beschreibung
PK Blood Sample: Paliperidone
Alias
- UMLS CUI-1
- C0201734
- UMLS CUI-2
- C0178913
- UMLS CUI-3
- C0753678
Beschreibung
Specimen taken
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1277698
Beschreibung
Accession number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1510755
- UMLS CUI [1,2]
- C2826726
Beschreibung
Comment, blood specimen
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0178913
Beschreibung
Lab Sample Central Lab
Alias
- UMLS CUI-1
- C3244292
Beschreibung
Urine Dipstick Pregnancy Test
Alias
- UMLS CUI-1
- C0430056
Beschreibung
Dipstick Pregnancy Test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0430056
Beschreibung
Reason for no pregnancy test
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0032976
Beschreibung
Pregnancy Test Result
Datentyp
integer
Alias
- UMLS CUI [1]
- C0427777
Beschreibung
Abnormal Involuntary Movement Scale
Alias
- UMLS CUI-1
- C0450978
Beschreibung
AIMS: Muscles of facial expression
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640439
Beschreibung
AIMS: Lips and perioral area
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640440
Beschreibung
AIMS: Jaw
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640441
Beschreibung
AIMS: Tongue
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640442
Beschreibung
AIMS: Upper arm
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640443
Beschreibung
AIMS: Lower extremities
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640444
Beschreibung
AIMS: Neck, shoulders, hip
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640445
Beschreibung
AIMS: Severity of abnormal movements
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640446
Beschreibung
AIMS: Incapacitation due to abnormal movements
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640447
Beschreibung
AIMS: Subject´s awareness of abnormal movements
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640448
Beschreibung
AIMS: Current problems with teeth and/or dentures
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640449
Beschreibung
AIMS: Does the subject usually wear dentures?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3640450
Beschreibung
Barnes Akathisia Rating Scale
Alias
- UMLS CUI-1
- C3541345
Beschreibung
BARS: Objective
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640451
Beschreibung
BARS: Awareness of restlessness
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640452
Beschreibung
BARS: Reported distress related to restlessness
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640453
Beschreibung
BARS: Global clinical rating of akathisia
Datentyp
integer
Alias
- UMLS CUI [1]
- C3640454
Beschreibung
Simpson Angus Rating Scale
Alias
- UMLS CUI-1
- C0030569
- UMLS CUI-2
- C0450973
Beschreibung
Gait
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0016928
- UMLS CUI [1,2]
- C0450973
Beschreibung
Arm dropping
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0231650
- UMLS CUI [1,2]
- C0450973
Beschreibung
Shoulder shaking
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0037004
- UMLS CUI [1,2]
- C1883023
- UMLS CUI [1,3]
- C0450973
Beschreibung
Elbow rigidity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013769
- UMLS CUI [1,2]
- C0858572
- UMLS CUI [1,3]
- C0450973
Beschreibung
Wrist rigidity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0043262
- UMLS CUI [1,2]
- C0858572
- UMLS CUI [1,3]
- C0450973
Beschreibung
Leg pendulousness
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C4068836
- UMLS CUI [1,3]
- C0450973
Beschreibung
Head dropping
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018670
- UMLS CUI [1,2]
- C1705648
- UMLS CUI [1,3]
- C0450973
Beschreibung
Glabella tap
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0576550
- UMLS CUI [1,2]
- C0450973
Beschreibung
Tremor
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0040822
- UMLS CUI [1,2]
- C0450973
Beschreibung
Salivation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0036104
- UMLS CUI [1,2]
- C0450973
Beschreibung
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version
Alias
- UMLS CUI-1
- C3641328
Beschreibung
SSRS: Wish to be dead
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641578
Beschreibung
SSRS: Description of wish to be dead
Datentyp
text
Alias
- UMLS CUI [1]
- C3641579
Beschreibung
SSRS: Non-specific active suicidal thoughts
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641580
Beschreibung
SSRS: Description of Non-Specific Active Suicidal Thoughts
Datentyp
text
Alias
- UMLS CUI [1]
- C3641581
Beschreibung
SSRS: Active suicidal ideation with any methods (not plan) without intent to act
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641582
Beschreibung
SSRS: Description of Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Datentyp
text
Alias
- UMLS CUI [1]
- C3641583
Beschreibung
SSRS: Active suicidal ideation with some intent to act, without specific plan
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641605
Beschreibung
SSRS: Description of Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Datentyp
text
Alias
- UMLS CUI [1]
- C3641606
Beschreibung
SSRS: Active suicidal ideation with specific plan and intent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641607
Beschreibung
SSRS: Description of Active Suicidal Ideation with Specific Plan and Intent
Datentyp
text
Alias
- UMLS CUI [1]
- C3641584
Beschreibung
SSRS: Most Severe Ideation
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641585
Beschreibung
SSRS: Description of Ideation
Datentyp
text
Alias
- UMLS CUI [1]
- C3641586
Beschreibung
SSRS: Frequency
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641587
Beschreibung
SSRS: Duration
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641588
Beschreibung
SSRS: Controllability
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641589
Beschreibung
SSRS: Deterrents
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641590
Beschreibung
SSRS: Reasons for ideation
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641591
Beschreibung
SSRS: Actual Suicide Attempt
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641592
Beschreibung
SSRS: Number of Actual Suicide Attempts
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641593
Beschreibung
SSRS: Description of Actual Suicide Attempts
Datentyp
text
Alias
- UMLS CUI [1]
- C3641594
Beschreibung
SSRS: Non-suicidal self-injurious behavior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641595
Beschreibung
SSRS: Interrupted Suicide Attempt
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641596
Beschreibung
SSRS: Number of Interrupted Suicide Attempts
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641597
Beschreibung
SSRS: Description of Interrupted Suicide Attempts
Datentyp
text
Alias
- UMLS CUI [1]
- C3641598
Beschreibung
SSRS: Aborted Suicide Attempt
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641599
Beschreibung
SSRS: Number of Aborted Suicide Attempts
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641600
Beschreibung
SSRS: Description of Aborted Suicide Attempt
Datentyp
text
Alias
- UMLS CUI [1]
- C3641601
Beschreibung
SSRS: Preparatory Acts or Behaviors Toward Suicide Attempt
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641602
Beschreibung
SSRS: Description of Preparatory Acts or Behaviors Toward Suicide Attempt
Datentyp
text
Alias
- UMLS CUI [1]
- C3641603
Beschreibung
SSRS: Suicidal Behavior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641604
Beschreibung
SSRS: Completed suicide
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641338
Beschreibung
SSRS: Most Lethal Suicide Attempt Date
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C3641339
Beschreibung
SSRS: Most Lethal Suicide Attempt Damage
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641340
Beschreibung
SSRS: Most Lethal Suicide Attempt Potential
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641341
Beschreibung
Investigator Evaluation of lnjection site
Alias
- UMLS CUI-1
- C0035173
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C2700396
Beschreibung
Rater's initials
Datentyp
text
Alias
- UMLS CUI [1]
- C3166278
Beschreibung
Time of evaluation
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C2700396
Beschreibung
Redness of injection site
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C2700396
Beschreibung
Swelling of injection site
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C2700396
Beschreibung
Induration of injection site
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0332534
- UMLS CUI [1,2]
- C2700396
Beschreibung
Subject Evaluation of lnjection site
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C2700396
Beschreibung
Positive and Negative Syndrome Scale for Schizophrenia
Alias
- UMLS CUI-1
- C4086747
- UMLS CUI-2
- C0036341
Beschreibung
Rater's initials
Datentyp
text
Alias
- UMLS CUI [1]
- C3166278
Beschreibung
PANSS: Delusions
Datentyp
integer
Alias
- UMLS CUI [1]
- C4087066
Beschreibung
PANSS: Conceptual disorganization
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086687
Beschreibung
PANSS: Hallucinatory behavior
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086696
Beschreibung
PANSS: Excitement
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086693
Beschreibung
PANSS: Grandiosity
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086694
Beschreibung
PANSS: Suspiciousness/persecution
Datentyp
integer
Alias
- UMLS CUI [1]
- C4087067
Beschreibung
PANSS: Hostility
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086697
Beschreibung
PANSS: Blunted affect
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086686
Beschreibung
PANSS: Emotional withdrawal
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086692
Beschreibung
PANSS: Poor rapport
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086705
Beschreibung
PANSS: Passive/apathetic social withdrawal
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086702
Beschreibung
PANSS: Difficulty in abstract thinking
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086689
Beschreibung
PANSS: Lack of spontaneity and flow of conversation
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086699
Beschreibung
PANSS: Stereotyped thinking
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086708
Beschreibung
PANSS: Somatic concern
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086707
Beschreibung
PANSS: Anxiety
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086685
Beschreibung
PANSS: Guilt feelings
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086695
Beschreibung
PANSS: Tension
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086709
Beschreibung
PANSS: Mannerisms and posturing
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086700
Beschreibung
PANSS: Depression
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086688
Beschreibung
PANSS: Motor retardation
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086701
Beschreibung
PANSS: Uncooperativeness
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086710
Beschreibung
PANSS: Unusual thought content
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086711
Beschreibung
PANSS: Disorientation
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086690
Beschreibung
PANSS: Poor attention
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086703
Beschreibung
PANSS: Lack of judgment and insight
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086698
Beschreibung
PANSS: Disturbance of volition
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086691
Beschreibung
PANSS: Poor impulse control
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086704
Beschreibung
PANSS: Preoccupation
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086706
Beschreibung
PANSS: Active social avoidence
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086684
Beschreibung
Calculated total PANSS score
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C4086747
- UMLS CUI [1,2]
- C0449820
Beschreibung
Clinical Global Impression - Severity
Alias
- UMLS CUI-1
- C3639708
Beschreibung
Rater´s initials
Datentyp
text
Alias
- UMLS CUI [1]
- C3166278
Beschreibung
Clinical global impression of subject's psychotic disorder
Datentyp
integer
Alias
- UMLS CUI [1]
- C3698629
Beschreibung
Personal and Social Performance Scale
Alias
- UMLS CUI-1
- C0450973
- UMLS CUI-2
- C0037397
Beschreibung
Rater's initials
Datentyp
text
Alias
- UMLS CUI [1]
- C3166278
Beschreibung
Socially useful activities, including work and study
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641834
Beschreibung
Personal and social relationships
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021797
Beschreibung
Self-care
Datentyp
integer
Alias
- UMLS CUI [1]
- C0474417
Beschreibung
Disturbing and aggressive behaviors
Datentyp
integer
Alias
- UMLS CUI [1]
- C0001807
Beschreibung
Total score
Datentyp
integer
Alias
- UMLS CUI [1]
- C2964552
Beschreibung
Administration of trial medication
Alias
- UMLS CUI-1
- C3854006
- UMLS CUI-2
- C3469597
Beschreibung
Medication Kit Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2981406
- UMLS CUI [1,2]
- C3854006
Beschreibung
Dispensation Date
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826773
Beschreibung
Study drug administrator's initials
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C3854006
Beschreibung
Date of injection
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021485
Beschreibung
Actual clock time of injection
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0021485
Beschreibung
Injection site
Datentyp
integer
Alias
- UMLS CUI [1]
- C2700396
Beschreibung
Medication Kit Dispensation
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1880359
- UMLS CUI-3
- C1690540
Beschreibung
Date medication kit assigned
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1516050
- UMLS CUI [1,3]
- C3854006
- UMLS CUI [1,4]
- C1690540
Beschreibung
Medication kit number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2981406
- UMLS CUI [1,2]
- C3854006
Ähnliche Modelle
Visit 5 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
- StudyEvent: ODM
C3274661 (UMLS CUI [1,2])
C0443144 (UMLS CUI [1,2])
C0178913 (UMLS CUI-2)
C0753678 (UMLS CUI-3)
C2826726 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C2826726 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
C0450973 (UMLS CUI-2)
C1883023 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
C4068836 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
C1705648 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
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])
C0037397 (UMLS CUI-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])