ID
30660
Descripción
Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993
Palabras clave
Versiones (3)
- 18/6/18 18/6/18 -
- 19/6/18 19/6/18 -
- 27/9/21 27/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
19 de junio de 2018
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024
Screening
- StudyEvent: ODM
Descripción
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Descripción
Demography
Alias
- UMLS CUI-1
- C0011298
Descripción
Date of Birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Childbearing potential
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3831118
Descripción
Race
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034510
Descripción
Demography - Geographic Ancestry
Alias
- UMLS CUI-1
- C3841890
Descripción
Geographic Ancestry
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034510
Descripción
Contraceptive Methods
Alias
- UMLS CUI-1
- C0700589
Descripción
Check all that apply
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0700589
Descripción
Specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Descripción
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Descripción
Entry criteria
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1516637
Descripción
Inclusion/Exclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-3
- C0680251
Descripción
Inclusion / Exclusion Criteria
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1512693
- UMLS CUI [2]
- C0680251
Descripción
Inclusion/Exclusion criteria applies
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1512693
- UMLS CUI [2]
- C0680251
- UMLS CUI [3]
- C1552663
Descripción
Screen Failure
Alias
- UMLS CUI-1
- C1710476
Descripción
A subject who is assigned a subject number, but is not randomised has failed screening.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1710476
Descripción
Screen Failure Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1710476
Descripción
If adverse event, record details in the Non-Serious Adverse Events or Serious Adverse Event forms as appropriate.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0392360
Descripción
Specify Reason for Screen Failure
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0392360
Descripción
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Descripción
Is this casebook ready to sign?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2346576
Descripción
By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1706256
Descripción
Previous Clinical Trial Participation
Alias
- UMLS CUI-1
- C2348568
Descripción
Previous study
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2242969
Descripción
Subject number
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1709561
Descripción
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descripción
Assessment Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2985720
Descripción
Height
Tipo de datos
text
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descripción
Weight
Tipo de datos
text
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
BMI
Tipo de datos
text
Unidades de medida
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Descripción
PGx-Pharmacogenetic Research Consent
Alias
- UMLS CUI-1
- C0008976
- UMLS CUI-2
- C0021430
Descripción
informed consent
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0021430
Descripción
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Descripción
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0005834
Descripción
Please specify if "Has blood sample been collected for PGx-Pharmacogenetic Research?"=Yes
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
Descripción
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=No
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705116
- UMLS CUI [1,3]
- C0392360
Descripción
If other, please specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705116
- UMLS CUI [1,3]
- C0392360
Descripción
hidden
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2347029
Descripción
Medical conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Descripción
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011900
Descripción
Disease
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0012634
Descripción
IHS Headache Classification
Alias
- UMLS CUI-1
- C0018681
- UMLS CUI-3
- C3846158
Descripción
Migraine history
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0262926
Descripción
Number of migraine attacks
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1304680
- UMLS CUI [1,3]
- C0439507
Descripción
Duration of migraine attack
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0449238
Descripción
(... years old)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0206132
Descripción
Migraine recurrence
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0034897
Descripción
Migraine recurrence delay
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C2985752
Descripción
Nr of headache episodes
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C4086638
Descripción
Nr of no headache episodes
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C4086638
- UMLS CUI [1,3]
- C1298908
Descripción
Previous treatment for migraine
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0087111
Descripción
Treatment for migraine
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
Descripción
medication for migraine treatment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0013227
Descripción
Other previous treatment for migraine
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C1514463
Descripción
other migraine treatment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0205394
Descripción
previous use of medication for migraine treatment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
Descripción
satisfaction with medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0242428
- UMLS CUI [1,2]
- C0013216
Descripción
Prior treatment medication satisfaction questions
Alias
- UMLS CUI-1
- C3476649
Descripción
Date of completion
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
medication effectiveness
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0087113
Descripción
medication side effects
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2984047
Descripción
medication satisfaction
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3476649
Similar models
Screening
- StudyEvent: ODM
(Comment:en)
(Comment:en)
C2585377 (UMLS CUI-2)
(Comment:en)
C3873750 (UMLS CUI-2)
(Comment:en)
(Comment:en)
(Comment:en)
C0004764 (UMLS CUI-2)
(Comment:en)
C0205394 (UMLS CUI [1,2])
C0680251 (UMLS CUI-3)
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
C1552663 (UMLS CUI [3])
C1710476 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0021430 (UMLS CUI-2)
C0021430 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C3846158 (UMLS CUI-3)
C1304680 (UMLS CUI [1,2])
C0439507 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0206132 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
C2985752 (UMLS CUI [1,3])
C4086638 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C0087111 (UMLS CUI-2)
C0087111 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C1514463 (UMLS CUI-2)
C0087111 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,2])