ID
44579
Beschreibung
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
Stichworte
Versionen (3)
- 18.06.18 18.06.18 -
- 19.06.18 19.06.18 -
- 27.09.21 27.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
27. September 2021
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024
Screening
- StudyEvent: ODM
Beschreibung
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date of Birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Childbearing potential
Datentyp
text
Alias
- UMLS CUI [1]
- C3831118
Beschreibung
Race
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Demography - Geographic Ancestry
Alias
- UMLS CUI-1
- C3841890
Beschreibung
Geographic Ancestry
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Contraceptive Methods
Alias
- UMLS CUI-1
- C0700589
Beschreibung
Check all that apply
Datentyp
integer
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
Specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Beschreibung
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschreibung
Entry criteria
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1516637
Beschreibung
Inclusion/Exclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-3
- C0680251
Beschreibung
Inclusion / Exclusion Criteria
Datentyp
text
Alias
- UMLS CUI [1]
- C1512693
- UMLS CUI [2]
- C0680251
Beschreibung
Inclusion/Exclusion criteria applies
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1512693
- UMLS CUI [2]
- C0680251
- UMLS CUI [3]
- C1552663
Beschreibung
Screen Failure
Alias
- UMLS CUI-1
- C1710476
Beschreibung
A subject who is assigned a subject number, but is not randomised has failed screening.
Datentyp
text
Alias
- UMLS CUI [1]
- C1710476
Beschreibung
Screen Failure Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1710476
Beschreibung
If adverse event, record details in the Non-Serious Adverse Events or Serious Adverse Event forms as appropriate.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0392360
Beschreibung
Specify Reason for Screen Failure
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0392360
Beschreibung
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
Is this casebook ready to sign?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1706256
Beschreibung
Previous Clinical Trial Participation
Alias
- UMLS CUI-1
- C2348568
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Assessment Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Height
Datentyp
text
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
text
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
BMI
Datentyp
text
Maßeinheiten
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
PGx-Pharmacogenetic Research Consent
Alias
- UMLS CUI-1
- C0008976
- UMLS CUI-2
- C0021430
Beschreibung
informed consent
Datentyp
text
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Beschreibung
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes
Datentyp
text
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Please specify if "Has blood sample been collected for PGx-Pharmacogenetic Research?"=Yes
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
Beschreibung
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=No
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705116
- UMLS CUI [1,3]
- C0392360
Beschreibung
If other, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705116
- UMLS CUI [1,3]
- C0392360
Beschreibung
hidden
Datentyp
text
Alias
- UMLS CUI [1]
- C2347029
Beschreibung
Medical conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beschreibung
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
Disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
IHS Headache Classification
Alias
- UMLS CUI-1
- C0018681
- UMLS CUI-3
- C3846158
Beschreibung
Migraine history
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0262926
Beschreibung
Number of migraine attacks
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1304680
- UMLS CUI [1,3]
- C0332177
Beschreibung
Duration of migraine attack
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0449238
Beschreibung
(... years old)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0206132
Beschreibung
Migraine recurrence
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0034897
Beschreibung
Migraine recurrence delay
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C2985752
Beschreibung
Nr of headache episodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C4086638
Beschreibung
Nr of no headache episodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C4086638
- UMLS CUI [1,3]
- C1298908
Beschreibung
Previous treatment for migraine
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0087111
Beschreibung
Treatment for migraine
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
Beschreibung
medication for migraine treatment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0013227
Beschreibung
Other previous treatment for migraine
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C1514463
Beschreibung
other migraine treatment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0205394
Beschreibung
previous use of medication for migraine treatment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
Beschreibung
satisfaction with medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0242428
- UMLS CUI [1,2]
- C0013216
Beschreibung
Prior treatment medication satisfaction questions
Alias
- UMLS CUI-1
- C3476649
Beschreibung
Date of completion
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
medication effectiveness
Datentyp
text
Alias
- UMLS CUI [1]
- C0087113
Beschreibung
medication side effects
Datentyp
text
Alias
- UMLS CUI [1]
- C2984047
Beschreibung
medication satisfaction
Datentyp
text
Alias
- UMLS CUI [1]
- C3476649
Ähnliche Modelle
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])
C0332177 (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])