ID
38536
Description
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders
Keywords
Versions (2)
- 9/22/19 9/22/19 -
- 10/24/19 10/24/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 24, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636
Screening
- StudyEvent: ODM
Description
Date of Visit/Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Description
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Patient date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Childbearing Potential
Data type
text
Alias
- UMLS CUI [1]
- C3831118
Description
Ethnic group
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
Your ancestry or national origin
Data type
text
Alias
- UMLS CUI [1]
- C3841890
Description
Pharmacogenetic (PGx) Research Consent / Blood Sample Collection
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C0005834
Description
Pharmacogenetic Test, Informed Consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
Description
Pharmacogenetic Test, Informed Consent, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0011008
Description
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0005834
Description
Pharmacogenetic Test, Informed Consent, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Description
Pharmacogenetic Test, Informed Consent, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Description
Pharmacogenetic (PGx) Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
Description
Pharmacogenetic Test, Informed Consent, Withdraw
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Description
Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
- UMLS CUI [1,4]
- C0011008
Description
Pharmacogenetic Test, Blood specimen, Destruction, Request
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
Description
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
- UMLS CUI [1,5]
- C0566251
Description
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
- UMLS CUI [1,5]
- C0566251
Description
Screen Failure
Alias
- UMLS CUI-1
- C1710476
Description
Trial Screen Failure
Data type
boolean
Alias
- UMLS CUI [1]
- C1710476
Description
Trial Screen Failure, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Description
Trial Screen Failure, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Description
Trial Screen Failure, Clinical Study Case, Investigator Signature
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C1706256
- UMLS CUI [1,4]
- C2346576
Description
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Description
Eligibility Determination
Data type
boolean
Alias
- UMLS CUI [1]
- C0013893
Description
Inclusion
Data type
text
Alias
- UMLS CUI [1]
- C1512693
Description
Exclusion Criteria
Data type
text
Alias
- UMLS CUI [1]
- C0680251
Description
Status of Medications
Alias
- UMLS CUI-1
- C2347852
Description
Concomitant Agent
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Concomitant Agent, Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Description
Concomitant Agent, Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Description
Concomitant Agent, Medication name, Reported Term
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [1,3]
- C2826302
Description
Concomitant Agent, Pharmaceutical Preparations, Synonym
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0871468
Description
Concomitant Agent, Code
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
Description
Concomitant Agent, Code, Failed
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Description
Concomitant Agent, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0011008
Description
Concomitant Agent, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0040223
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Data type
float
Measurement units
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Description
Systolic Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Systolic Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Systolic Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Systolic Pressure, Low, Average
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Description
Diastolic blood pressure, Low, Average
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
12 lead ECG, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Description
12 lead ECG, Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Description
12 lead ECG, P-R Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Description
12 lead ECG, QRS complex duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
12 lead ECG, QT Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Description
12 lead ECG, Electrocardiogram QT corrected interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
12 lead ECG, Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Description
12 lead ECG, QRS Axis
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429012
Description
12 lead ECG, RR interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0489636
Description
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Description
Clinical Study Case, Investigator Signature
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C2346576
Description
Clinical Study Case, Investigator Signature
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C2346576
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Screening
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
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C2985720 (UMLS CUI [1,2])
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C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
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C0231175 (UMLS CUI [1,3])
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C1510992 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,2])
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C0011008 (UMLS CUI [1,2])
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C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C0429012 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])