ID

31908

Description

This ODM file contains the form to document the telemetry. 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. 10/7/18 10/7/18 -
  2. 10/8/18 10/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 8, 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

Telemetry

1 forms  
  1. StudyEvent: ODM
    1. Telemetry
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
Telemetry
Description

Telemetry

Alias
UMLS CUI-1
C0039451
Was continuous telemetry monitoring completed?
Description

Continuous telemetry monitoring

Data type

text

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C0549178
If Yes, Start time:
Description

Telemetry start time

Data type

time

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C1301880
If Yes, Stop time:
Description

Telemetry stop time

Data type

time

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C1522314
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Similar models

Telemetry

1 forms
  1. StudyEvent: ODM
    1. Telemetry
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 of Period 1 (1)
CL Item
Day 1 of Period 2 (2)
Item Group
Telemetry
C0039451 (UMLS CUI-1)
Item
Was continuous telemetry monitoring completed?
text
C0039451 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuous telemetry monitoring
Code List
Was continuous telemetry monitoring completed?
CL Item
Yes (Y)
(Comment:en)
CL Item
No (N)
(Comment:en)
Telemetry start time
Item
If Yes, Start time:
time
C0039451 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Telemetry stop time
Item
If Yes, Stop time:
time
C0039451 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
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