ID

26665

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

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Inglés

Adverse Event

1 formularios  
  1. StudyEvent: ODM
    1. Adverse Event
Please note any SERIOUS events should not be recorded on this page, but on the Serious Adverse Event pages provided. Record any Adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: "Do you feel different in any way since starting the treatment or since the last visit?" Provide the diagnosis not symptoms where possible. (One adverse event per column) If no adverse events, please mark box D and sign form below
Descripción

Please note any SERIOUS events should not be recorded on this page, but on the Serious Adverse Event pages provided. Record any Adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: "Do you feel different in any way since starting the treatment or since the last visit?" Provide the diagnosis not symptoms where possible. (One adverse event per column) If no adverse events, please mark box D and sign form below

Alias
UMLS CUI-1
C0877248
Adverse Event
Descripción

Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
GSK Use
Descripción

Investigator Use

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
Onset Date/Time
Descripción

Onset Date/Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826806
End Date/Time
Descripción

End Date/Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Descripción

Outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
Event Course
Descripción

Event Course

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity (Maximum)
Descripción

Intensity

Tipo de datos

text

Alias
UMLS CUI [1]
C1710066
Action Taken with Respect to lnvestigational Drug
Descripción

Drug Action Taken

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0304229
Relationship to lnvestigational Drug
Descripción

Relationship to lnvestigational Drug

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Corrective Therapy. If "Yes", Please record on Concomitant Medication form
Descripción

Corrective Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this AE?
Descripción

Study withdrawal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0877248
Administrative Documentation
Descripción

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Investigator's Signature:
Descripción

Investigators Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date
Descripción

Investigator Signature Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0807937
UMLS CUI [1,2]
C2346576
Volver a la parte superior de la página

Similar models

Adverse Event

1 formularios
  1. StudyEvent: ODM
    1. Adverse Event
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Please note any SERIOUS events should not be recorded on this page, but on the Serious Adverse Event pages provided. Record any Adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: "Do you feel different in any way since starting the treatment or since the last visit?" Provide the diagnosis not symptoms where possible. (One adverse event per column) If no adverse events, please mark box D and sign form below
C0877248 (UMLS CUI-1)
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Investigator Use
Item
GSK Use
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Onset Date/Time
Item
Onset Date/Time
datetime
C2826806 (UMLS CUI [1])
End Date/Time
Item
End Date/Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course
CL Item
Intermittent (Number of Episodes) (Intermittent (Number of Episodes))
CL Item
Constant (Constant)
Item
Intensity (Maximum)
text
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (Maximum)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Action Taken with Respect to lnvestigational Drug
text
C2826626 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Drug Action Taken
Code List
Action Taken with Respect to lnvestigational Drug
CL Item
None (None)
CL Item
Dose Reduced (Dose Reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose interrupted/restarted (Dose interrupted/restarted)
CL Item
Drug stopped (Drug stopped)
Item
Relationship to lnvestigational Drug
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Relationship to lnvestigational Drug
Code List
Relationship to lnvestigational Drug
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (Reasonable possibility) (Suspected (Reasonable possibility))
CL Item
Probable (Probable)
Corrective Therapy
Item
Corrective Therapy. If "Yes", Please record on Concomitant Medication form
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Study withdrawal
Item
Was subject withdrawn due to this AE?
boolean
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Investigators Signature
Item
Investigator's Signature:
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C0807937 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial