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Informações:
Falhas:
ID
30809
Descrição
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
Palavras-chave
Versões (3)
- 21/06/2018 21/06/2018 -
- 21/06/2018 21/06/2018 -
- 20/09/2021 20/09/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
21 de junho de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024
Similar models
LOG Visit
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Date of Visit
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
Migraine attack 1 symptoms
C0149931 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C1457887 (UMLS CUI-2)
start date migraine attack
Item
Enter the date and time your migraine headache pain started
datetime
C0149931 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
woke up with migraine headache pain
Item
Did you wake up with your migraine headache pain?
boolean
C0442696 (UMLS CUI [1,1])
C0149931 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,3])
C0149931 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,3])
migraine with aura
Item
Did you have aura?
boolean
C0154723 (UMLS CUI [1])
pain worsened by physical activity
Item
Pain worsened by physical activity?
boolean
C0018681 (UMLS CUI [1,1])
C4054844 (UMLS CUI [1,2])
C4054844 (UMLS CUI [1,2])
Item
What best describes the quality of your migraine headache pain?
text
C0149931 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
C1148406 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,2])
C1148406 (UMLS CUI [1,3])
Code List
What best describes the quality of your migraine headache pain?
CL Item
Pulsing, throbbing, or pounding pain (1)
CL Item
Pressure/tightening (2)
Item
What best describes the location of your migraine headache pain?
text
C0149931 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,4])
C0018681 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,4])
Code List
What best describes the location of your migraine headache pain?
CL Item
Only one side of head (1)
CL Item
On both sides of head (2)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
Migraine attack 1 headache pain and symptoms
C0149931 (UMLS CUI-1)
C0018681 (UMLS CUI-2)
C0030193 (UMLS CUI-3)
C1457887 (UMLS CUI-4)
C0018681 (UMLS CUI-2)
C0030193 (UMLS CUI-3)
C1457887 (UMLS CUI-4)
Item
Time since drug intake
text
C0011008 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
CL Item
0 hour (at time of dosing) (1)
(Comment:en)
CL Item
1 hour after dose (2)
(Comment:en)
CL Item
2 hous after dose (3)
(Comment:en)
CL Item
4 hours after dose (4)
(Comment:en)
Item
How severe is your migraine headache pain?
text
C0149931 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
C1504479 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,2])
C1504479 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Nausea
Item
Nausea symptoms
boolean
C0027497 (UMLS CUI [1])
Vomiting
Item
Vomiting symptom
integer
C0042963 (UMLS CUI [1])
Light sensitivity
Item
Light sensitivity symptom
boolean
C0085636 (UMLS CUI [1])
Sound sensitivity
Item
Sound sensitivity symptom
boolean
C2938899 (UMLS CUI [1])
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name (Trade name preferred)
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Date and time medication taken
Item
Date and time medication taken
datetime
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
CL Item
Mild Migraine Headache Pain (1)
CL Item
Moderate Migraine Headache Pain (2)
CL Item
Severe Migraine Headache Pain (3)
CL Item
Other Reason, Specify (4)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Item
Time since drug intake
text
C0011008 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
CL Item
0 hour (at time of dosing) (1)
(Comment:en)
CL Item
1 hour after dose (2)
(Comment:en)
CL Item
2 hous after dose (3)
(Comment:en)
CL Item
4 hours after dose (4)
(Comment:en)
Item
How do you rate your ability to do school work or perform you usual activities?
text
C0441655 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,2])
Code List
How do you rate your ability to do school work or perform you usual activities?
CL Item
Normal (1)
CL Item
Mildly impaired (2)
CL Item
Moderately impaired (3)
CL Item
Severely impaired (4)
CL Item
Required bedrest (5)
Item Group
Investigational product accountability
C0304229 (UMLS CUI-1)
C0078889 (UMLS CUI-2)
C0078889 (UMLS CUI-2)
investigational product container number
Item
Investigational product container numbers assigned
integer
C3898691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
total number of tablets dispensed
Item
Total Number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
total number of tablets taken
Item
Total Number of Tablets taken
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
Returned Date
Item
Returned Date
date
C0013227 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0180098 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Sequence Number
Item
Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
total number of tablets returned
Item
Total Number of Tablets Returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Date and time of second tablet
Item
Date and time of second tablet
datetime
C0013227 (UMLS CUI [1,1])
C1717740 (UMLS CUI [1,2])
C1717740 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
Language used in diary assessment
C3890583 (UMLS CUI-1)
C0023008 (UMLS CUI-2)
C0023008 (UMLS CUI-2)
ISO language
Item
ISO language
text
C1708640 (UMLS CUI [1])