ID

32019

Description

This ODM-file contains the data collection questions for demographics and childbearing potential. To be assessed at screening. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Keywords

Versions (2)
  1. 10/12/18 10/12/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 12, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396

English

Demographics and Childbearing Potential

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
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: Pick one:
Description

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, pick Not Hispanic or Latino. • Not Hispanic or Latino Neither Hispanic or Latino

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry: 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
Geographic Ancestry: 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
Geographic Ancestry: Asian - Central/South Asian Heritage
Description

A person having origins in Central Asia (Kazakstan, Kyrgystan, Tajikstan, Turkmenistan and Uzbekistan) and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)

Data type

boolean

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

A person having origins in China, Korea

Data type

boolean

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

A person having origins in Japan

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Geographic Ancestry: Asian - South East Asia 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
Geographic Ancestry: 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
Geographic Ancestry: 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]
C0026068
Geographic Ancestry: 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
Child-bearing Potential (Complete for Female Subjects Only)
Description

Child-bearing Potential (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C3831118
Tick one:
Description

Child-bearing Potential (Complete for Female Subjects Only) Definitions • Post-menopausal Women who have completed menopause at least one year ago. • Sterile Pre-menopausal women who cannot conceive children. (This category includes women who have become sterile through surgical procedures such as tubal ligation. Do not include post-menopausal women in this category.) • Potentially able to bear children Women of child-bearing age who are not sterile. Note: If the subject is sterile and is not of child-bearing age, then ‘post-menopausal’ will be the best choice and should be picked. If the subject is sterile and does not know if she is post-menopausal and is less than 62 years of age, then she is of child-bearing age and ‘sterile’ should be picked.

Data type

integer

Alias
UMLS CUI [1]
C3831118
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Similar models

Demographics and Childbearing Potential

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
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)
C1706180 (UMLS CUI-1)
(Comment:en)
CL Item
Female (F)
C0015780 (UMLS CUI-1)
(Comment:en)
Item
Ethnicity: Pick one:
integer
C0015031 (UMLS CUI [1])
Ethnicity: Hispanic or Latino, Not Hispanic or Latino
Code List
Ethnicity: Pick one:
CL Item
Hispanic or Latino (1)
C0086409 (UMLS CUI-1)
C0086528 (UMLS CUI-3)
(Comment:en)
CL Item
Not Hispanic or Latino (2)
C1518424 (UMLS CUI-1)
(Comment:en)
Geographic Ancestry: African American/African Heritage
Item
Geographic Ancestry: African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
Geographic Ancestry: American Indian or Alaskan Native
Item
Geographic Ancestry: American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Geographic Ancestry: Asian - Central/South Asian Heritage
Item
Geographic Ancestry: Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Geographic Ancestry: Asian - East Asian Heritage
Item
Geographic Ancestry: Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Geographic Ancestry: Asian - Japanese Heritage
Item
Geographic Ancestry: Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Geographic Ancestry: Asian - South East Asia Heritage
Item
Geographic Ancestry: Asian - South East Asia Heritage
boolean
C0238697 (UMLS CUI [1])
Geographic Ancestry: Native Hawaiian or Other Pacific Islander
Item
Geographic Ancestry: Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
Geographic Ancestry: White - Arabic/North African Heritage
Item
Geographic Ancestry: White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C0026068 (UMLS CUI [2])
Geographic Ancestry: White - White/Caucasian European Heritage
Item
Geographic Ancestry: White - White/Caucasian European Heritage
boolean
C0043157 (UMLS CUI [1])
Item Group
Child-bearing Potential (Complete for Female Subjects Only)
C3831118 (UMLS CUI-1)
Item
Tick one:
integer
C3831118 (UMLS CUI [1])
Child-bearing potential (complete for female subjects only)
Code List
Tick one:
CL Item
Post-menopausal (2)
C0021359 (UMLS CUI-1)
(Comment:en)
CL Item
Sterile (of child-bearing age) (3)
C3831118 (UMLS CUI-1)
(Comment:en)
CL Item
Potentially able to bear children (4)
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