ID

34412

Beschrijving

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.

Trefwoorden

Versies (3)
  1. 11-01-19 11-01-19 -
  2. 11-01-19 11-01-19 -
  3. 17-01-19 17-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

17 januari 2019

DOI

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Licentie

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

Engels

Demographics

1 Formulieren  
  1. StudyEvent: ODM
    1. Demographics
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
Demography
Beschrijving

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschrijving

Date of Birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschrijving

Tick one

Datatype

integer

Alias
UMLS CUI [1]
C0015031
Race
Beschrijving

Race

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

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

Datatype

boolean

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

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

Datatype

boolean

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

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

Datatype

boolean

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

A person having origins in China, Korea

Datatype

boolean

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

A person having origins in Japan

Datatype

boolean

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

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

Datatype

boolean

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

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

Datatype

boolean

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

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

Datatype

boolean

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

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

Datatype

boolean

Alias
UMLS CUI [1]
C0043157
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Similar models

Demographics

1 Formulieren
  1. StudyEvent: ODM
    1. Demographics
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
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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