ID

22222

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)
  1. 23.05.17 23.05.17 -
Hochgeladen am

23. Mai 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Visit 19 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Englisch

Visit 19 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

1 Formulare  
Date of visit
Beschreibung

Date of visit

Alias
UMLS CUI-1
C1320303
Visit date
Beschreibung

Date of visit

Datentyp

date

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

Vital Signs Pulse and Blood Pressure

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

Pulse at rest

Datentyp

integer

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

SBP at rest

Datentyp

integer

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

DBP at rest

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C2183311
mmHg
Standing after 2 minutes: Pulse
Beschreibung

Pulse while standing

Datentyp

integer

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

SBP standing

Datentyp

integer

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

DBP standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C1303019
mmHg
Actual Position
Beschreibung

Patient position finding

Datentyp

integer

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

PK Blood Sample: Paliperidone

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

Specimen taken

Datentyp

boolean

Alias
UMLS CUI [1]
C1277698
Accession number
Beschreibung

Accession number

Datentyp

integer

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

Comment, blood specimen

Datentyp

text

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

Mini Positive and Negative Syndrome Scale for Schizophrenia

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

Rater's initials

Datentyp

text

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

PANSS: Delusions

Datentyp

integer

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

PANSS: Conceptual disorganization

Datentyp

integer

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

PANSS: Hallucinatory behavior

Datentyp

integer

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

PANSS: Suspiciousness/persecution

Datentyp

integer

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

PANSS: Hostility

Datentyp

integer

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

PANSS: Uncooperativeness

Datentyp

integer

Alias
UMLS CUI [1]
C4086710
Evaluation of relapse
Beschreibung

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)
Beschreibung

Psychiatric hospitalization

Datentyp

boolean

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

Psychiatric hospitalization date

Datentyp

date

Maßeinheiten
  • 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.
Beschreibung

Worsening of schizophrenic symptoms, PANSS

Datentyp

boolean

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

Date, worsening of schizophrenic symptoms

Datentyp

date

Maßeinheiten
  • 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
Beschreibung

Worsening of schizophrenic symptoms, PANSS

Datentyp

boolean

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

Date, worsening of schizophrenic symptoms

Datentyp

date

Maßeinheiten
  • 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?
Beschreibung

Self-injury, physical aggression

Datentyp

boolean

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

Date of self-injury or physical aggression

Datentyp

date

Maßeinheiten
  • 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:
Beschreibung

Specification self-injury or physical aggression

Datentyp

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?
Beschreibung

Suicidal or homicidal ideation, aggressive behavior

Datentyp

boolean

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

Date of suicidal or homicidal ideation, aggressive behavior

Datentyp

date

Maßeinheiten
  • 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:
Beschreibung

Specification of suicidal or homicidal ideation, aggressive behavior

Datentyp

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
Beschreibung

Worsening of schizophrenic symptoms, PANSS

Datentyp

boolean

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

Date, worsening of schizophrenic symptoms

Datentyp

date

Maßeinheiten
  • 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
Beschreibung

Worsening of schizophrenic symptoms, PANSS

Datentyp

boolean

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

Date, worsening of schizophrenic symptoms

Datentyp

date

Maßeinheiten
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C1546960
dd.mm.yyyy
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Visit 19 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video