ID

31895

Description

This ODM-file contains a form to document the vital signs. 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 (2)
  1. 10/3/18 10/3/18 -
  2. 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 106396

English

Vital Signs Day -1 of Period 1 and 2

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
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1]
C3641100
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

Date of the measurement of the vital signs

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Time
Description

Time of the measurement of the vital signs

Data type

time

Alias
UMLS CUI [1]
C2826762
Blood pressure Systolic/Diastolic
Description

Sitting

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Description

Heart rate

Data type

text

Measurement units
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
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Similar models

Vital Signs Day -1 of Period 1 and 2

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
Visit Type
integer
C3641100 (UMLS CUI [1])
Visit Type
Code List
Visit Type
CL Item
Day-1 Period 1 (1)
CL Item
Day-1 Period 2 (2)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date of the measurement of the vital signs
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of the measurement of the vital signs
Item
Time
time
C2826762 (UMLS CUI [1])
Blood pressure
Item
Blood pressure Systolic/Diastolic
text
C0005823 (UMLS CUI [1])
Heart rate
Item
Heart rate
text
C0018810 (UMLS CUI [1])
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