ID

34412

Description

Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders The purpose of this form is to document the subjects demographic data. It should be filled out at the screening visit.

Keywords

Versions (3)
  1. 1/11/19 1/11/19 -
  2. 1/11/19 1/11/19 -
  3. 1/17/19 1/17/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 17, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

English

Demographics

1 forms  
  1. StudyEvent: ODM
    1. Demographics
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Tick one

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race
Description

Race

Alias
UMLS CUI-1
C0034510
African American/African Heritage
Description

A person having origins in any of the black racial groups of Africa

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
American Indian or Alaskan Native
Description

A person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Asian - Central/South Asian Heritage
Description

A person having origins in Central Asia and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Asian - East Asian Heritage
Description

A person having origins in China, Korea

Data type

boolean

Alias
UMLS CUI [1]
C4540996
Asian - Japanese Heritage
Description

A person having origins in Japan

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Asian - South East Asian Heritage
Description

A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Native Hawaiian or Other Pacific Islander
Description

A person having origins in any of the original peoples of Hawaii, Guam, Samoa or other Pacific Islands, Australia (Aborigines), Papua New Guinea, New Zealand, Marshalls and other island groups west and south of Japan

Data type

boolean

Alias
UMLS CUI [1]
C1513907
White - Arabic/North African Heritage
Description

A person having origins in any of the original peoples of Middle East or North Africa

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C1552588
White - White/Caucasian/European Heritage
Description

A person having origins in any of the original peoples of Europe

Data type

boolean

Alias
UMLS CUI [1]
C0043157
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Similar models

Demographics

1 forms
  1. StudyEvent: ODM
    1. Demographics
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (m)
CL Item
female (f)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Race
C0034510 (UMLS CUI-1)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
American Indian or Alaskan Native
Item
American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Asian - Central/South Asian Heritage
Item
Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Asian - East Asian Heritage
Item
Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Asian - Japanese Heritage
Item
Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Asian - South East Asian Heritage
Item
Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
White - Arabic/North African Heritage
Item
White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C1552588 (UMLS CUI [2])
White - White/Caucasian/European Heritage
Item
White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
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