ID

22229

Descripción

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

Palabras clave

Versiones (1)
  1. 24/5/17 24/5/17 -
Subido en

24 de mayo de 2017

DOI

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Licencia

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

Inglés

Confirmation Visit - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

1 formularios  
Date of visit
Descripción

Date of visit

Alias
UMLS CUI-1
C1320303
Visit date
Descripción

Date of visit

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1320303
dd.mm.yyyy
Positive and Negative Syndrome Scale for Schizophrenia
Descripción

Positive and Negative Syndrome Scale for Schizophrenia

Alias
UMLS CUI-1
C4086747
UMLS CUI-2
C0036341
Rater's initials
Descripción

Rater's initials

Tipo de datos

text

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

PANSS: Delusions

Tipo de datos

integer

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

PANSS: Conceptual disorganization

Tipo de datos

integer

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

PANSS: Hallucinatory behavior

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086696
Positive subscale: P04 Excitement
Descripción

PANSS: Excitement

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086693
Positive subscale: P05 Grandiosity
Descripción

PANSS: Grandiosity

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086694
Positive subscale: P06 Suspiciousness/persecution
Descripción

PANSS: Suspiciousness/persecution

Tipo de datos

integer

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

PANSS: Hostility

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086697
Negative subscale: N01 Blunted affect
Descripción

PANSS: Blunted affect

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086686
Negative subscale: N02 Emotional withdrawal
Descripción

PANSS: Emotional withdrawal

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086692
Negative subscale: N03 Poor rapport
Descripción

PANSS: Poor rapport

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086705
Negative subscale: N04 Passive/apathetic social withdrawal
Descripción

PANSS: Passive/apathetic social withdrawal

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086702
Negative subscale: N05 Difficulty in abstract thinking
Descripción

PANSS: Difficulty in abstract thinking

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086689
Negative subscale: N06 Lack of spontaneity and flow of conversation
Descripción

PANSS: Lack of spontaneity and flow of conversation

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086699
Negative subscale: N07 Stereotyped thinking
Descripción

PANSS: Stereotyped thinking

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086708
General psychopathology subscale: G01 Somatic concern
Descripción

PANSS: Somatic concern

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086707
General psychopathology subscale: G02 Anxiety
Descripción

PANSS: Anxiety

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086685
General psychopathology subscale: G03 Guilt feelings
Descripción

PANSS: Guilt feelings

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086695
General psychopathology subscale: G04 Tension
Descripción

PANSS: Tension

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086709
General psychopathology subscale: G05 Mannerisms and posturing
Descripción

PANSS: Mannerisms and posturing

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086700
General psychopathology subscale: G06 Depression
Descripción

PANSS: Depression

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086688
General psychopathology subscale: G07 Motor retardation
Descripción

PANSS: Motor retardation

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086701
General psychopathology subscale: G08 Uncooperativeness
Descripción

PANSS: Uncooperativeness

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086710
General psychopathology subscale: G09 Unusual thought content
Descripción

PANSS: Unusual thought content

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086711
General psychopathology subscale: G10 Disorientation
Descripción

PANSS: Disorientation

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086690
General psychopathology subscale: G11 Poor attention
Descripción

PANSS: Poor attention

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086703
General psychopathology subscale: G12 Lack of judgment and insight
Descripción

PANSS: Lack of judgment and insight

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086698
General psychopathology subscale: G13 Disturbance of volition
Descripción

PANSS: Disturbance of volition

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086691
General psychopathology subscale: G14 Poor impulse control
Descripción

PANSS: Poor impulse control

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086704
General psychopathology subscale: G15 Preoccupation
Descripción

PANSS: Preoccupation

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086706
General psychopathology subscale: G16 Active social avoidence
Descripción

PANSS: Active social avoidence

Tipo de datos

integer

Alias
UMLS CUI [1]
C4086684
Calculated total PANSS score
Descripción

Calculated total PANSS score

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C0449820
Evaluation of relapse
Descripción

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)
Descripción

Psychiatric hospitalization

Tipo de datos

boolean

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

Psychiatric hospitalization date

Tipo de datos

date

Unidades de medida
  • 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.
Descripción

Worsening of schizophrenic symptoms, PANSS

Tipo de datos

boolean

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

Date, worsening of schizophrenic symptoms

Tipo de datos

date

Unidades de medida
  • 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
Descripción

Worsening of schizophrenic symptoms, PANSS

Tipo de datos

boolean

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

Date, worsening of schizophrenic symptoms

Tipo de datos

date

Unidades de medida
  • 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?
Descripción

Self-injury, physical aggression

Tipo de datos

boolean

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

Date of self-injury or physical aggression

Tipo de datos

date

Unidades de medida
  • 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:
Descripción

Specification self-injury or physical aggression

Tipo de datos

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?
Descripción

Suicidal or homicidal ideation, aggressive behavior

Tipo de datos

boolean

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

Date of suicidal or homicidal ideation, aggressive behavior

Tipo de datos

date

Unidades de medida
  • 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:
Descripción

Specification of suicidal or homicidal ideation, aggressive behavior

Tipo de datos

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
Descripción

Worsening of schizophrenic symptoms, PANSS

Tipo de datos

boolean

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

Date, worsening of schizophrenic symptoms

Tipo de datos

date

Unidades de medida
  • 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
Descripción

Worsening of schizophrenic symptoms, PANSS

Tipo de datos

boolean

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

Date, worsening of schizophrenic symptoms

Tipo de datos

date

Unidades de medida
  • 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

Confirmation Visit - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Date of visit
C1320303 (UMLS CUI-1)
Date of visit
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Positive and Negative Syndrome Scale for Schizophrenia
C4086747 (UMLS CUI-1)
C0036341 (UMLS CUI-2)
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: P04 Excitement
integer
C4086693 (UMLS CUI [1])
PANSS: Excitement
Code List
Positive subscale: P04 Excitement
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: P05 Grandiosity
integer
C4086694 (UMLS CUI [1])
PANSS: Grandiosity
Code List
Positive subscale: P05 Grandiosity
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
Negative subscale: N01 Blunted affect
integer
C4086686 (UMLS CUI [1])
PANSS: Blunted affect
Code List
Negative subscale: N01 Blunted affect
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
Negative subscale: N02 Emotional withdrawal
integer
C4086692 (UMLS CUI [1])
PANSS: Emotional withdrawal
Code List
Negative subscale: N02 Emotional withdrawal
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
Negative subscale: N03 Poor rapport
integer
C4086705 (UMLS CUI [1])
PANSS: Poor rapport
Code List
Negative subscale: N03 Poor rapport
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
Negative subscale: N04 Passive/apathetic social withdrawal
integer
C4086702 (UMLS CUI [1])
PANSS: Passive/apathetic social withdrawal
Code List
Negative subscale: N04 Passive/apathetic social withdrawal
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
Negative subscale: N05 Difficulty in abstract thinking
integer
C4086689 (UMLS CUI [1])
PANSS: Difficulty in abstract thinking
Code List
Negative subscale: N05 Difficulty in abstract thinking
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
Negative subscale: N06 Lack of spontaneity and flow of conversation
integer
C4086699 (UMLS CUI [1])
PANSS: Lack of spontaneity and flow of conversation
Code List
Negative subscale: N06 Lack of spontaneity and flow of conversation
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
Negative subscale: N07 Stereotyped thinking
integer
C4086708 (UMLS CUI [1])
PANSS: Stereotyped thinking
Code List
Negative subscale: N07 Stereotyped thinking
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: G01 Somatic concern
integer
C4086707 (UMLS CUI [1])
PANSS: Somatic concern
Code List
General psychopathology subscale: G01 Somatic concern
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: G02 Anxiety
integer
C4086685 (UMLS CUI [1])
PANSS: Anxiety
Code List
General psychopathology subscale: G02 Anxiety
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: G03 Guilt feelings
integer
C4086695 (UMLS CUI [1])
PANSS: Guilt feelings
Code List
General psychopathology subscale: G03 Guilt feelings
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: G04 Tension
integer
C4086709 (UMLS CUI [1])
PANSS: Tension
Code List
General psychopathology subscale: G04 Tension
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: G05 Mannerisms and posturing
integer
C4086700 (UMLS CUI [1])
PANSS: Mannerisms and posturing
Code List
General psychopathology subscale: G05 Mannerisms and posturing
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: G06 Depression
integer
C4086688 (UMLS CUI [1])
PANSS: Depression
Code List
General psychopathology subscale: G06 Depression
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: G07 Motor retardation
integer
C4086701 (UMLS CUI [1])
PANSS: Motor retardation
Code List
General psychopathology subscale: G07 Motor retardation
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
General psychopathology subscale: G09 Unusual thought content
integer
C4086711 (UMLS CUI [1])
PANSS: Unusual thought content
Code List
General psychopathology subscale: G09 Unusual thought content
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: G10 Disorientation
integer
C4086690 (UMLS CUI [1])
PANSS: Disorientation
Code List
General psychopathology subscale: G10 Disorientation
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: G11 Poor attention
integer
C4086703 (UMLS CUI [1])
PANSS: Poor attention
Code List
General psychopathology subscale: G11 Poor attention
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: G12 Lack of judgment and insight
integer
C4086698 (UMLS CUI [1])
PANSS: Lack of judgment and insight
Code List
General psychopathology subscale: G12 Lack of judgment and insight
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: G13 Disturbance of volition
integer
C4086691 (UMLS CUI [1])
PANSS: Disturbance of volition
Code List
General psychopathology subscale: G13 Disturbance of volition
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: G14 Poor impulse control
integer
C4086704 (UMLS CUI [1])
PANSS: Poor impulse control
Code List
General psychopathology subscale: G14 Poor impulse control
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: G15 Preoccupation
integer
C4086706 (UMLS CUI [1])
PANSS: Preoccupation
Code List
General psychopathology subscale: G15 Preoccupation
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: G16 Active social avoidence
integer
C4086684 (UMLS CUI [1])
PANSS: Active social avoidence
Code List
General psychopathology subscale: G16 Active social avoidence
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)
Calculated total PANSS score
Item
Calculated total PANSS score
integer
C4086747 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
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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