ID

31894

Description

This ODM-file contains a form to fill in findings of the 12-lead ECG examination. To be assessed at Screening as well as at the follow up 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 (3)
  1. 10/3/18 10/3/18 -
  2. 10/3/18 10/3/18 -
  3. 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

12-Lead ECG

1 forms  
  1. StudyEvent: ODM
    1. 12-Lead ECG
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
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start date of ECG
Description

Start date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start time of ECG
Description

Start time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Result of the ECG
Description

Complete additional ECG Abnormalities page if clinically significant abnormalities are present.

Data type

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

12-Lead ECG

1 forms
  1. StudyEvent: ODM
    1. 12-Lead ECG
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
Screening (1)
CL Item
Follow-Up (2)
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Start date of ECG
Item
Start date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time of ECG
Item
Start time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
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