ID

31898

Descripción

This ODM file contains the form to record the results of the pregnancy test. To be assessed at Day -1 of Period 1 and 2. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Palabras clave

  1. 7/10/18 7/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

7 de octubre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0

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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396

Pregnancy Test

  1. StudyEvent: ODM
    1. Pregnancy Test
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Type
Descripción

Visit Type

Tipo de datos

integer

Alias
UMLS CUI [1]
C3641100
Subject identifier
Descripción

Subject identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Pregnancy Test (Complete for Female Subjects Only)
Descripción

Pregnancy Test (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C0032976
Date sample taken
Descripción

Date sample taken

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Results
Descripción

Results of Pregnancy Test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040

Similar models

Pregnancy Test

  1. StudyEvent: ODM
    1. Pregnancy Test
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Visit Type
integer
C3641100 (UMLS CUI [1])
Code List
Visit Type
CL Item
Day-1 of Period 1 (1)
CL Item
Day-1 of Period 2 (2)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Pregnancy Test (Complete for Female Subjects Only)
C0032976 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Results
integer
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not applicable (Not of childbearing potential) (3)

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