ID

31898

Description

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

Keywords

Versions (1)
  1. 10/7/18 10/7/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 7, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396

English

Pregnancy Test

1 forms  
  1. StudyEvent: ODM
    1. Pregnancy Test
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1]
C3641100
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

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

Pregnancy Test (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C0032976
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Results
Description

Results of Pregnancy Test

Data type

integer

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

Pregnancy Test

1 forms
  1. StudyEvent: ODM
    1. Pregnancy Test
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Visit Type
integer
C3641100 (UMLS CUI [1])
Visit Type
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])
Results of Pregnancy Test
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not applicable (Not of childbearing potential) (3)
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