ID

31908

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-10-07 2018-10-07 -
  2. 2018-10-08 2018-10-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 oktober 2018

DOI

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Licens

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

Engelsk

Telemetry

1 Formulär  
  1. StudyEvent: ODM
    1. Telemetry
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beskrivning

Visit Type

Datatyp

integer

Alias
UMLS CUI [1]
C3641100
Telemetry
Beskrivning

Telemetry

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

Continuous telemetry monitoring

Datatyp

text

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

Telemetry start time

Datatyp

time

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

Telemetry stop time

Datatyp

time

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

Telemetry

1 Formulär
  1. StudyEvent: ODM
    1. Telemetry
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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