ID

34012

Beskrivning

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.

Nyckelord

Versioner (3)
  1. 2019-01-11 2019-01-11 -
  2. 2019-01-11 2019-01-11 -
  3. 2019-01-17 2019-01-17 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 januari 2019

DOI

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Licens

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

Engelsk

Demographics

1 Formulär  
  1. StudyEvent: ODM
    1. Demographics
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303 (Date of visit)
SNOMED
406543005
Demography
Beskrivning

Demography

Alias
UMLS CUI-1
C0011298 (Demography)
LOINC
LP204151-7
Date of Birth
Beskrivning

Date of Birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451 (Patient date of birth)
SNOMED
184099003
LOINC
LP57552-9
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI [1]
C0079399 (Gender)
SNOMED
263495000
LOINC
LP61312-2
Ethnicity
Beskrivning

Tick one

Datatyp

integer

Alias
UMLS CUI [1]
C0015031 (Ethnic group)
SNOMED
398089004
LOINC
LP36231-6
Race
Beskrivning

Race

Alias
UMLS CUI-1
C0034510 (Racial group)
SNOMED
415229000
LOINC
LP7528-5
African American/African Heritage
Beskrivning

African American/African Heritage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085756 (African American)
SNOMED
15086000
LOINC
LA10610-6
UMLS CUI [1,2]
C0027567 (African race)
SNOMED
413464008
American Indian or Alaskan Native
Beskrivning

American Indian or Alaskan Native

Datatyp

boolean

Alias
UMLS CUI [1]
C1515945 (American Indian or Alaska Native)
SNOMED
413490006
LOINC
LA10608-0
Asian - Central/South Asian Heritage
Beskrivning

Asian - Central/South Asian Heritage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0238696 (Central Asian)
UMLS CUI [1,2]
C1519427 (South Asian)
Asian - East Asian Heritage
Beskrivning

Asian - East Asian Heritage

Datatyp

boolean

Alias
UMLS CUI [1]
C4540996 (East Asian ethnicity)
Asian - Japanese Heritage
Beskrivning

Asian - Japanese Heritage

Datatyp

boolean

Alias
UMLS CUI [1]
C1556094 (Japanese race)
SNOMED
414551003
LOINC
LA4595-0
Asian - South East Asian Heritage
Beskrivning

Asian - South East Asian Heritage

Datatyp

boolean

Alias
UMLS CUI [1]
C0238697 (South East Asian)
SNOMED
186044009
Native Hawaiian or Other Pacific Islander
Beskrivning

Native Hawaiian or Other Pacific Islander

Datatyp

boolean

Alias
UMLS CUI [1]
C1513907 (Native Hawaiian or Other Pacific Islander)
LOINC
LA10611-4
White - Arabic/North African Heritage
Beskrivning

White - Arabic/North African Heritage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0238604 (North African)
UMLS CUI [1,2]
C1552588 (Arabic <List Style>)
White - White/Caucasian/European Heritage
Beskrivning

White - White/Caucasian/European Heritage

Datatyp

boolean

Alias
UMLS CUI [1]
C0043157 (Caucasians)
SNOMED
185984009
LOINC
LA23729-9
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Similar models

Demographics

1 Formulär
  1. StudyEvent: ODM
    1. Demographics
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 [1,1])
C0027567 (UMLS CUI [1,2])
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 [1,1])
C1519427 (UMLS CUI [1,2])
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 [1,1])
C1552588 (UMLS CUI [1,2])
White - White/Caucasian/European Heritage
Item
White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
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