ID

22222

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 (1)
  1. 2017-05-23 2017-05-23 -
Uppladdad den

23 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Visit 19 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Engelsk

Visit 19 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

1 Formulär  
Date of visit
Beskrivning

Date of visit

Alias
UMLS CUI-1
C1320303
Visit date
Beskrivning

Date of visit

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1320303
dd.mm.yyyy
Vital Signs Pulse and Blood Pressure
Beskrivning

Vital Signs Pulse and Blood Pressure

Alias
UMLS CUI-1
C0518766
Supine after 5 minutes rest: Pulse
Beskrivning

Pulse at rest

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0443144
beats/min
Supine after 5 minutes rest: Systolic Blood Pressure
Beskrivning

SBP at rest

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C2039694
mmHg
Supine after 5 minutes rest: Diastolic Blood Pressure
Beskrivning

DBP at rest

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C2183311
mmHg
Standing after 2 minutes: Pulse
Beskrivning

Pulse while standing

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
Standing after 2 minutes: Systolic Blood Pressure
Beskrivning

SBP standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C1303018
mmHg
Standing after 2 minutes: Diastolic Blood Pressure
Beskrivning

DBP standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C1303019
mmHg
Actual Position
Beskrivning

Patient position finding

Datatyp

integer

Alias
UMLS CUI [1]
C0449850
PK Blood Sample: Paliperidone
Beskrivning

PK Blood Sample: Paliperidone

Alias
UMLS CUI-1
C0201734
UMLS CUI-2
C0178913
UMLS CUI-3
C0753678
Specimen taken
Beskrivning

Specimen taken

Datatyp

boolean

Alias
UMLS CUI [1]
C1277698
Accession number
Beskrivning

Accession number

Datatyp

integer

Alias
UMLS CUI [1,1]
C1510755
UMLS CUI [1,2]
C2826726
Specimen comments, if any
Beskrivning

Comment, blood specimen

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0178913
Mini Positive and Negative Syndrome Scale for Schizophrenia
Beskrivning

Mini Positive and Negative Syndrome Scale for Schizophrenia

Alias
UMLS CUI-1
C1282927
UMLS CUI-2
C4086747
UMLS CUI-3
C0036341
Rater's initials
Beskrivning

Rater's initials

Datatyp

text

Alias
UMLS CUI [1]
C3166278
Positive subscale: P01 Delusions
Beskrivning

PANSS: Delusions

Datatyp

integer

Alias
UMLS CUI [1]
C4087066
Positive subscale: P02 Conceptual disorganization
Beskrivning

PANSS: Conceptual disorganization

Datatyp

integer

Alias
UMLS CUI [1]
C4086687
Positive subscale: P03 Hallucinatory behavior
Beskrivning

PANSS: Hallucinatory behavior

Datatyp

integer

Alias
UMLS CUI [1]
C4086696
Positive subscale: P06 Suspiciousness/persecution
Beskrivning

PANSS: Suspiciousness/persecution

Datatyp

integer

Alias
UMLS CUI [1]
C4087067
Positive subscale: P07 Hostility
Beskrivning

PANSS: Hostility

Datatyp

integer

Alias
UMLS CUI [1]
C4086697
General psychopathology subscale: G08 Uncooperativeness
Beskrivning

PANSS: Uncooperativeness

Datatyp

integer

Alias
UMLS CUI [1]
C4086710
Evaluation of relapse
Beskrivning

Evaluation of relapse

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0035020
1.Since the last visit, has the subject had a psychiatric hospitalization (involuntary or voluntary admission to a psychiatric hospital for decompensation of the subject´s schizophrenic symptoms)
Beskrivning

Psychiatric hospitalization

Datatyp

boolean

Alias
UMLS CUI [1]
C0748061
If `yes`, please enter date of psychiatric hospitalization:
Beskrivning

Psychiatric hospitalization date

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0748061
UMLS CUI [1,2]
C0011008
dd.mm.yyyy
2.Worsening: A. An increase of >= 25% in total PANSS score from randomization if the score at randomization was >40.
Beskrivning

Worsening of schizophrenic symptoms, PANSS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1546960
UMLS CUI [1,3]
C4086747
If `yes`, please enter date:
Beskrivning

Date, worsening of schizophrenic symptoms

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C1546960
dd.mm.yyyy
2.Worsening: B. A 10 point increase in total PANSS score from randomization if the score at randomization was <= 40
Beskrivning

Worsening of schizophrenic symptoms, PANSS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1546960
UMLS CUI [1,3]
C4086747
If `yes`, please enter date:
Beskrivning

Date, worsening of schizophrenic symptoms

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C1546960
dd.mm.yyyy
3.Since the last visit, has the subject had a deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury to him/her self or another person or significant property damage?
Beskrivning

Self-injury, physical aggression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178360
UMLS CUI [1,2]
C0424323
If `yes`, please enter date of event:
Beskrivning

Date of self-injury or physical aggression

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0178360
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0424323
dd.mm.yyyy
If `yes`, describe the event:
Beskrivning

Specification self-injury or physical aggression

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0178360
UMLS CUI [1,3]
C0424323
4.Since the last visit, has the subject had a suicidal or homicidal ideation and aggressive behavior that was clinically significant (in frequency and severity) in the investigator´s judgment?
Beskrivning

Suicidal or homicidal ideation, aggressive behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0749133
UMLS CUI [1,2]
C0455204
UMLS CUI [1,3]
C0001807
If `yes`, please enter date of event:
Beskrivning

Date of suicidal or homicidal ideation, aggressive behavior

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0749133
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0455204
UMLS CUI [1,5]
C0011008
UMLS CUI [1,6]
C0001807
dd.mm.yyyy
If `yes`, describe the event:
Beskrivning

Specification of suicidal or homicidal ideation, aggressive behavior

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0749133
UMLS CUI [1,3]
C0455204
UMLS CUI [1,4]
C0001807
5.Worsening of any one of the following PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility) or G8 (uncooperativeness) to: A. A score of >= 5 after randomization on any of the above PANSS items if the maximum score for the above PANSS items was <= 3 at randomization
Beskrivning

Worsening of schizophrenic symptoms, PANSS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1546960
UMLS CUI [1,3]
C4086747
If `yes`, please enter date:
Beskrivning

Date, worsening of schizophrenic symptoms

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C1546960
dd.mm.yyyy
5.Worsening of any one of the following PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility) or G8 (uncooperativeness) to: B. A score of >= 6 after randomization on any of the above PANSS items if the maximum score for the above PANSS items was = 4 at randomization
Beskrivning

Worsening of schizophrenic symptoms, PANSS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1546960
UMLS CUI [1,3]
C4086747
If `yes`, please enter date:
Beskrivning

Date, worsening of schizophrenic symptoms

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C1546960
dd.mm.yyyy
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Similar models

Visit 19 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of visit
C1320303 (UMLS CUI-1)
Date of visit
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs Pulse and Blood Pressure
C0518766 (UMLS CUI-1)
Pulse at rest
Item
Supine after 5 minutes rest: Pulse
integer
C0232117 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
SBP at rest
Item
Supine after 5 minutes rest: Systolic Blood Pressure
integer
C2039694 (UMLS CUI [1])
DBP at rest
Item
Supine after 5 minutes rest: Diastolic Blood Pressure
integer
C2183311 (UMLS CUI [1])
Pulse while standing
Item
Standing after 2 minutes: Pulse
integer
C2029905 (UMLS CUI [1])
SBP standing
Item
Standing after 2 minutes: Systolic Blood Pressure
integer
C1303018 (UMLS CUI [1])
DBP standing
Item
Standing after 2 minutes: Diastolic Blood Pressure
integer
C1303019 (UMLS CUI [1])
Item
Actual Position
integer
C0449850 (UMLS CUI [1])
Patient position finding
Code List
Actual Position
CL Item
Standing (1)
CL Item
Sitting (2)
CL Item
Supine (3)
Item Group
PK Blood Sample: Paliperidone
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0753678 (UMLS CUI-3)
Specimen taken
Item
Specimen taken
boolean
C1277698 (UMLS CUI [1])
Accession number
Item
Accession number
integer
C1510755 (UMLS CUI [1,1])
C2826726 (UMLS CUI [1,2])
Comment, blood specimen
Item
Specimen comments, if any
text
C0947611 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item Group
Mini Positive and Negative Syndrome Scale for Schizophrenia
C1282927 (UMLS CUI-1)
C4086747 (UMLS CUI-2)
C0036341 (UMLS CUI-3)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Item
Positive subscale: P01 Delusions
integer
C4087066 (UMLS CUI [1])
PANSS: Delusions
Code List
Positive subscale: P01 Delusions
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P02 Conceptual disorganization
integer
C4086687 (UMLS CUI [1])
PANSS: Conceptual disorganization
Code List
Positive subscale: P02 Conceptual disorganization
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P03 Hallucinatory behavior
integer
C4086696 (UMLS CUI [1])
PANSS: Hallucinatory behavior
Code List
Positive subscale: P03 Hallucinatory behavior
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P06 Suspiciousness/persecution
integer
C4087067 (UMLS CUI [1])
PANSS: Suspiciousness/persecution
Code List
Positive subscale: P06 Suspiciousness/persecution
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P07 Hostility
integer
C4086697 (UMLS CUI [1])
PANSS: Hostility
Code List
Positive subscale: P07 Hostility
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G08 Uncooperativeness
integer
C4086710 (UMLS CUI [1])
PANSS: Uncooperativeness
Code List
General psychopathology subscale: G08 Uncooperativeness
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item Group
Evaluation of relapse
C0220825 (UMLS CUI-1)
C0035020 (UMLS CUI-2)
Psychiatric hospitalization
Item
1.Since the last visit, has the subject had a psychiatric hospitalization (involuntary or voluntary admission to a psychiatric hospital for decompensation of the subject´s schizophrenic symptoms)
boolean
C0748061 (UMLS CUI [1])
Psychiatric hospitalization date
Item
If `yes`, please enter date of psychiatric hospitalization:
date
C0748061 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Worsening of schizophrenic symptoms, PANSS
Item
2.Worsening: A. An increase of >= 25% in total PANSS score from randomization if the score at randomization was >40.
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Worsening of schizophrenic symptoms, PANSS
Item
2.Worsening: B. A 10 point increase in total PANSS score from randomization if the score at randomization was <= 40
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Self-injury, physical aggression
Item
3.Since the last visit, has the subject had a deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury to him/her self or another person or significant property damage?
boolean
C0178360 (UMLS CUI [1,1])
C0424323 (UMLS CUI [1,2])
Date of self-injury or physical aggression
Item
If `yes`, please enter date of event:
date
C0011008 (UMLS CUI [1,1])
C0178360 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0424323 (UMLS CUI [1,4])
Item
If `yes`, describe the event:
integer
C2348235 (UMLS CUI [1,1])
C0178360 (UMLS CUI [1,2])
C0424323 (UMLS CUI [1,3])
Specification self-injury or physical aggression
Code List
If `yes`, describe the event:
CL Item
Deliberate self-injury  (1)
CL Item
Violent behavior resulting in suicide, injury or property damage (2)
Suicidal or homicidal ideation, aggressive behavior
Item
4.Since the last visit, has the subject had a suicidal or homicidal ideation and aggressive behavior that was clinically significant (in frequency and severity) in the investigator´s judgment?
boolean
C0749133 (UMLS CUI [1,1])
C0455204 (UMLS CUI [1,2])
C0001807 (UMLS CUI [1,3])
Date of suicidal or homicidal ideation, aggressive behavior
Item
If `yes`, please enter date of event:
date
C0011008 (UMLS CUI [1,1])
C0749133 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0455204 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0001807 (UMLS CUI [1,6])
Item
If `yes`, describe the event:
integer
C2348235 (UMLS CUI [1,1])
C0749133 (UMLS CUI [1,2])
C0455204 (UMLS CUI [1,3])
C0001807 (UMLS CUI [1,4])
Specification of suicidal or homicidal ideation, aggressive behavior
Code List
If `yes`, describe the event:
CL Item
Suicide attempt  (1)
CL Item
Suicidal ideation  (2)
CL Item
Homicidal ideation (3)
Worsening of schizophrenic symptoms, PANSS
Item
5.Worsening of any one of the following PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility) or G8 (uncooperativeness) to: A. A score of >= 5 after randomization on any of the above PANSS items if the maximum score for the above PANSS items was <= 3 at randomization
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Worsening of schizophrenic symptoms, PANSS
Item
5.Worsening of any one of the following PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility) or G8 (uncooperativeness) to: B. A score of >= 6 after randomization on any of the above PANSS items if the maximum score for the above PANSS items was = 4 at randomization
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
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