ID

22188

Descrição

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

Palavras-chave

22/05/2017 22/05/2017 -

Transferido a

22 de maio de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

model
Detalhes

Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

1 Formulários

StudyEvent: ODM
1. Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Date of visit

Item Group

Date of visit

C1320303 (UMLS CUI-1)

Date of visit

Item

Visit date

date

C1320303 (UMLS CUI [1])

Vital signs

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])

Patient position finding

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)

Pharmacokinetics, Blood Sample, Paliperidone

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])

Positive and Negative Syndrome Scale for Schizophrenia

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])

PANSS: Delusions

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)

PANSS: Conceptual disorganization

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)

PANSS: Hallucinatory behavior

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)

PANSS: Excitement

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)

PANSS: Grandiosity

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)

PANSS: Suspiciousness/persecution

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)

PANSS: Hostility

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)

PANSS: Blunted affect

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)

PANSS: Emotional withdrawal

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)

PANSS: Poor rapport

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)

PANSS: Passive/apathetic social withdrawal

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)

PANSS: Difficulty in abstract thinking

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)

PANSS: Lack of spontaneity and flow of conversation

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)

PANSS: Stereotyped thinking

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)

PANSS: Somatic concern

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)

PANSS: Anxiety

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)

PANSS: Guilt feelings

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)

PANSS: Tension

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)

PANSS: Mannerisms and posturing

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)

PANSS: Depression

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)

PANSS: Motor retardation

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)

PANSS: Uncooperativeness

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)

PANSS: Unusual thought content

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)

PANSS: Disorientation

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)

PANSS: Poor attention

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)

PANSS: Lack of judgment and insight

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)

PANSS: Disturbance of volition

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)

PANSS: Poor impulse control

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)

PANSS: Preoccupation

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)

PANSS: Active social avoidence

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])

Clinical Global Impression - Severity

Item Group

Clinical Global Impression - Severity

C3639708 (UMLS CUI-1)

Rater´s initials

Item

Rater´s initials

text

C3166278 (UMLS CUI [1])

Clinical global impression of subject's psychotic disorder

Item

Considering your total clinical experience with this particular population, how severe is the subject's psychotic disorder at this time?

integer

C3698629 (UMLS CUI [1])

Clinical global impression of subject's psychotic disorder

Code List

Considering your total clinical experience with this particular population, how severe is the subject's psychotic disorder at this time?

CL Item

normal, not at all ill (1)

CL Item

borderline mentally ill (2)

CL Item

mildly ill (3)

CL Item

moderately ill (4)

CL Item

markedly ill (5)

CL Item

severely ill (6)

CL Item

among the most extremely ill patients (7)

Voltar ao início da página

ID

Descrição

Link

Palavras-chave

Versões (1)

Transferido a

DOI

Licença

Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Descrição

Alias

Descrição

Tipo de dados

Unidades de medida

Alias

Descrição

Alias

Descrição

Tipo de dados

Unidades de medida

Alias

Descrição

Tipo de dados

Unidades de medida

Alias

Descrição

Tipo de dados

Unidades de medida

Alias

Descrição

Tipo de dados

Unidades de medida

Alias

Descrição

Tipo de dados

Unidades de medida

Alias

Descrição

Tipo de dados

Unidades de medida

Alias

Descrição

Tipo de dados

Alias

Descrição

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição