ID

26652

Descripción

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

Palabras clave

Versiones (1)
  1. 23/10/17 23/10/17 -
Titular de derechos de autor

GSK

Subido en

23 de octubre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Inglés

Session 3 Day 1 Pre-Dose

1 formularios  
Default Itemgroup
Descripción

Default Itemgroup

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Urine Pregnancy Test (Females only)
Descripción

Urine Pregnancy Test (Females only)

Alias
UMLS CUI-1
C0430056
Was a pregnancy test carried out?
Descripción

Urine Pregnancy Test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0430056
If 'No', please specify reason
Descripción

undefined item

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0032976
If 'YES'. please indicate date and time of test and result: Date and Time of pregnancy test:
Descripción

Date | Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0032976
If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
Descripción

Test result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0032976
Clinical Chemistry and Haematology ensure a blood sample has been taken tor clinical chemistry and haematology
Descripción

Clinical Chemistry and Haematology ensure a blood sample has been taken tor clinical chemistry and haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Exact date and time of blood sampling
Descripción

Date | Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Comments
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
Descripción

Abnormal Lab values

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C2826293
Urinalysis Ensure a urine sample has been taken tor clinical chemistry and haematology
Descripción

Urinalysis Ensure a urine sample has been taken tor clinical chemistry and haematology

Alias
UMLS CUI-1
C0042014
Exact date and time of urine sampling
Descripción

Date | Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Comments
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
Descripción

Abnormal test results

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C2826293
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Similar models

Session 3 Day 1 Pre-Dose

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Default Itemgroup
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Urine Pregnancy Test (Females only)
C0430056 (UMLS CUI-1)
Urine Pregnancy Test
Item
Was a pregnancy test carried out?
boolean
C0430056 (UMLS CUI [1])
undefined item
Item
If 'No', please specify reason
text
C0392360 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Date | Time
Item
If 'YES'. please indicate date and time of test and result: Date and Time of pregnancy test:
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
Item
If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
text
C0456984 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Test result
Code List
If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Clinical Chemistry and Haematology ensure a blood sample has been taken tor clinical chemistry and haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date | Time
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Abnormal Lab values
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
boolean
C0438215 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Item Group
Urinalysis Ensure a urine sample has been taken tor clinical chemistry and haematology
C0042014 (UMLS CUI-1)
Date | Time
Item
Exact date and time of urine sampling
datetime
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Abnormal test results
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
boolean
C0438215 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Volver a la parte superior de la página 

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