ID
37569
Description
Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders
Keywords
Versions (1)
- 8/7/19 8/7/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 7, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625
Follow-Up - Vital Signs; Electronically Transferred Lab Data; Study Conclusion; Pregnancy Information
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Vital Signs - Actual Time
Data type
time
Alias
- UMLS CUI [1]
- C2826762
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
(Position must be consistent throughout the study)
Data type
integer
Alias
- UMLS CUI [1]
- C1262869
Description
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0745590
- UMLS CUI-2
- C1705822
Description
Haematology Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Description
Haematology sample not taken
Data type
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Description
Clinical Chemistry Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Description
Clinical Chemistry sample not taken
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Description
Clinical Chemistry same as the Haematology sample
Data type
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [2]
- C0018941
Description
Urinalysis Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Description
Urinalysis sample not taken.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
Date of last contact
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
Was the subject withdrawn from the study?
Data type
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
Date of decision to withdraw
Data type
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0011008
Description
Primary reason for withdrawal from study
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Description
Data owner should check the box when data cleaning is complete
Data type
integer
Alias
- UMLS CUI [1]
- C1519316
Description
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
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Follow-Up - Vital Signs; Electronically Transferred Lab Data; Study Conclusion; Pregnancy Information
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [2])
C1705822 (UMLS CUI-2)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,2])