ID

32631

Beschrijving

This ODM-file contains the form to document the demography of the subject. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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

Trefwoorden

Versies (2)
  1. 31-10-18 31-10-18 -
  2. 09-11-18 09-11-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

9 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

Engels

Demography

1 Formulieren  
  1. StudyEvent: ODM
    1. Demography
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
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, tick one:
Beschrijving

ETHNICITY • Hispanic or Latino A person of Cuban, Mexican, Puerto Rican, South American or other Spanish culture or origin, regardless of race Note: If the subject does not meet the definition above, ✔ Not Hispanic or Latino. • Not Hispanic or Latino Neither Hispanic or Latino

Datatype

text

Alias
UMLS CUI [1]
C0015031
Race: African American/African Heritage
Beschrijving

The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 1] A person having origins in any of the black racial groups of Africa

Datatype

boolean

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

The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick✔ multiple boxes. [1 2] 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
Race: Asian - Central/South Asian Heritage
Beschrijving

The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 3] 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
Race: Asian - East Asian Heritage
Beschrijving

The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 4] A person having origins in China, Korea

Datatype

boolean

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

The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 5] A person having origins in Japan

Datatype

boolean

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

The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 6] A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia

Datatype

boolean

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

The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 7] 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
Race: White - Arabic/North African Heritage
Beschrijving

The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 8] 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]
C0026068
Race: White - White/Caucasian/European Heritage
Beschrijving

The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 9] 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

Demography

1 Formulieren
  1. StudyEvent: ODM
    1. Demography
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (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, tick one:
text
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity, tick one:
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Race: African American/African Heritage
Item
Race: African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
Race: American Indian or Alaskan Native
Item
Race: American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Race: Asian - Central/South Asian Heritage
Item
Race: Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Race: Asian - East Asian Heritage
Item
Race: Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Race: Asian - Japanese Heritage
Item
Race: Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Race: Asian - South East Asian Heritage
Item
Race: Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Race: Native Hawaiian or Other Pacific Islander
Item
Race: Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
Race: White - Arabic/North African Heritage
Item
Race: White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C0026068 (UMLS CUI [2])
Race: White - White/Caucasian/European Heritage
Item
Race: White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
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