ID

31860

Description

This ODM-file contains a form to fill in findings of the laboratory, serology and pregnancy testing. To be assessed at the screening visit. 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 (2)
  1. 10/3/18 10/3/18 -
  2. 10/4/18 10/4/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 4, 2018

DOI

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License

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

English

Laboratory Tests, Serology and Pregnancy Test

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
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
Laboratory Tests - Clinical Chemistry, Haematology
Description

Laboratory Tests - Clinical Chemistry, Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-3
C0018941
Was a blood sample taken for the clinical laboratory tests?
Description

Blood sample

Data type

text

Alias
UMLS CUI [1]
C0005834
If a blood sample was taken for the clinical laboratory tests: Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Serology
Description

Serology

Alias
UMLS CUI-1
C0036743
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
HIV antibody
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0920548
Hepatitis B surface antigen
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0201487
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 the pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0427777
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Similar models

Laboratory Tests, Serology and Pregnancy Test

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Laboratory Tests - Clinical Chemistry, Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-3)
Item
Was a blood sample taken for the clinical laboratory tests?
text
C0005834 (UMLS CUI [1])
Blood sample
Code List
Was a blood sample taken for the clinical laboratory tests?
CL Item
Yes (Y)
(Comment:en)
CL Item
No (N)
(Comment:en)
Date sample taken
Item
If a blood sample was taken for the clinical laboratory tests: Date sample taken
date
C1302413 (UMLS CUI [1])
Item Group
Serology
C0036743 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
HIV antibody
integer
C0920548 (UMLS CUI [1])
Results of the pregnancy test
Code List
HIV antibody
CL Item
Positive (1)
(Comment:en)
CL Item
Negative (2)
(Comment:en)
Item
Hepatitis B surface antigen
integer
C0019168 (UMLS CUI [1])
Results of the pregnancy test
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
(Comment:en)
CL Item
Negative (2)
(Comment:en)
Item
Hepatitis C antibody
integer
C0201487 (UMLS CUI [1])
Results of the pregnancy test
Code List
Hepatitis C antibody
CL Item
Positive (1)
(Comment:en)
CL Item
Negative (2)
(Comment:en)
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
C0427777 (UMLS CUI [1])
Results of the pregnancy test
Code List
Results
CL Item
Positive (1)
(Comment:en)
CL Item
Negative (2)
(Comment:en)
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