ID

32874

Beschrijving

This form contains a form to document the vital signs of the subject. To be assessed at screening. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 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

Link

https://clinicaltrials.gov/ct2/show/NCT00875784

Trefwoorden

  1. 17-11-18 17-11-18 -
  2. 21-11-18 21-11-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

17 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

Vital Signs (Screen)

  1. StudyEvent: ODM
    1. Vital Signs (Screen)
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Sitting measurement of vital signs
Beschrijving

Sitting measurement of vital signs

Alias
UMLS CUI-1
C0277814
UMLS CUI-2
C0518766
Actual date/time Hr:Min (00:00-23:59)
Beschrijving

Actual date/time of measurement of vital signs

Datatype

datetime

Alias
UMLS CUI [1]
C2826644
UMLS CUI [2,1]
C0518766
UMLS CUI [2,2]
C0040223
Height
Beschrijving

Height

Datatype

float

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschrijving

Body mass index

Datatype

float

Alias
UMLS CUI [1]
C1305855
Blood pressure (systolic)
Beschrijving

Blood pressure (systolic)

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (diastolic)
Beschrijving

Blood pressure (diastolic)

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute

Similar models

Vital Signs (Screen)

  1. StudyEvent: ODM
    1. Vital Signs (Screen)
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Sitting measurement of vital signs
C0277814 (UMLS CUI-1)
C0518766 (UMLS CUI-2)
Actual date/time of measurement of vital signs
Item
Actual date/time Hr:Min (00:00-23:59)
datetime
C2826644 (UMLS CUI [1])
C0518766 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Blood pressure (systolic)
Item
Blood pressure (systolic)
integer
C0871470 (UMLS CUI [1])
Blood pressure (diastolic)
Item
Blood pressure (diastolic)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])

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