ID

33051

Beschrijving

This form contains a form to document the vital signs assessed in case of early withdrawal. It is also a part of the logs/repeats documentation. 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. 18-11-18 18-11-18 -
  2. 25-11-18 25-11-18 -
  3. 25-11-18 25-11-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
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
Visit Type
Beschrijving

Visit Type

Datatype

text

Alias
UMLS CUI [1]
C3641100
Vital Signs
Beschrijving

Vital Signs

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

Actual date/time

Datatype

datetime

Alias
UMLS CUI [1]
C1264639
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/min
Alias
UMLS CUI [1]
C0018810
beats/min
Blood pressure not done
Beschrijving

Only optional for the logs/repeats measurement

Datatype

text

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C1272696
Heart rate not done
Beschrijving

Only optional for the logs/repeats measurement

Datatype

text

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1272696

Similar models

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
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
Visit Type
text
C3641100 (UMLS CUI [1])
Code List
Visit Type
CL Item
Early withdrawal (Early withdrawal)
CL Item
Logs/Repeats (Logs/Repeats)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date/time
Item
Actual date/time Hr:Min (00:00-23:59)
datetime
C1264639 (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])
Item
Blood pressure not done
text
C0005823 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Code List
Blood pressure not done
CL Item
Not done (Not done)
CL Item
done (done)
Item
Heart rate not done
text
C0018810 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Code List
Heart rate not done
CL Item
Not done (Not done)
CL Item
done (done)

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