Informations:
Erreur:
ID
30780
Description
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
Mots-clés
Versions (1)
- 20/06/2018 20/06/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
20 juin 2018
DOI
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Licence
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
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Date of Visit
Item
date
C1320303 (UMLS CUI [1])
non-serious adverse events
Item
boolean
C1518404 (UMLS CUI [1])
serious adverse events
Item
boolean
C1519255 (UMLS CUI [1])
concomitant medications
Item
boolean
C2347852 (UMLS CUI [1])
Sequence number
Item
integer
C2348184 (UMLS CUI [1])
Drug name
Item
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
text
C2826302 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
Unit Dose
Item
float
C0869039 (UMLS CUI [1])
Units
Item
text
C1519795 (UMLS CUI [1])
Frequency
Item
text
C3476109 (UMLS CUI [1])
Route
Item
text
C0013153 (UMLS CUI [1])
Reason for Medication
Item
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Generic Dispensed
Item
boolean
C3242750 (UMLS CUI [1])
CL Item
(1)
CL Item
(2)
Medication start datetime
Item
datetime
C3173309 (UMLS CUI [1])
Taken Prior to Study?
Item
boolean
C2826667 (UMLS CUI [1])
medication ongoing
Item
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication End Date
Item
date
C2826744 (UMLS CUI [1])
Device used to administer medication
Item
text
C0699733 (UMLS CUI [1])
Total Daily Dose
Item
integer
C2348070 (UMLS CUI [1])
drug adminstered for an exacerbation
Item
boolean
C3469597 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,2])
Rescue Medication
Item
boolean
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
C0884980 (UMLS CUI [1,2])
Total Dose
Item
kumulative Dosis
integer
C2986497 (UMLS CUI [1])
drug use
Item
boolean
C0242510 (UMLS CUI [1])
Total duration
Item
integer
C2347852 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
duration
Item
text
C0449238 (UMLS CUI [1])
Sequence Number
Item
text
C2348184 (UMLS CUI [1])
Non-serious adverse event
Item
text
C1518404 (UMLS CUI [1])
Modified term
Item
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Start Date
Item
date
C0808070 (UMLS CUI [1])
CL Item
(1)
C1709863 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(2)
C1709864 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(3)
C1709277 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(4)
C1709862 (UMLS CUI-1)
(Comment:en)
(Comment:en)
End date
Item
date
C0806020 (UMLS CUI [1])
CL Item
(1)
C2945599 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(2)
C0205081 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(3)
C0205082 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(X)
C1272460 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(1)
C2945599 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(2)
C0205081 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(3)
C0205082 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(X)
C1272460 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(1)
C0687695 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(2)
C1522446 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(3)
C0450094 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(4)
C0547054 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(5)
C2985911 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(1)
C0687695 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(2)
C1522446 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(3)
C0450094 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(4)
C0547054 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(5)
C2985911 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(X)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(X)
CL Item
(1)
C0304229 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(X)
C1272460 (UMLS CUI-1)
(Comment:en)
(Comment:en)
Withdrawal from study
Item
boolean
C0422727 (UMLS CUI [1])
AE caused by investigational product
Item
boolean
C0013230 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Duration of AE hours
Item
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Duration of AE minutes
Item
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Time to Onset Since Last Dose hours
Item
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Time to Onset Since Last Dose minutes
Item
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Initial report
Item
boolean
C0684224 (UMLS CUI [1])
Follow-up report
Item
boolean
C1704685 (UMLS CUI [1])
SAE after initiation of study medication
Item
boolean
C2826666 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Sequence Number
Item
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Modified term
Item
text
C2826302 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
MedDRA synonym
Item
text
C1140263 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
MedDRA lower level term code
Item
text
C3898442 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
serious adverse event
Item
boolean
C1519255 (UMLS CUI [1])
Did SAE occur after initiation of study medication
Item
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event
Item
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
C2697888 (UMLS CUI [1,2])
Start Time Serious Adverse Event
Item
time
C1519255 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
C2697889 (UMLS CUI [1,2])
Serious Adverse Event End Date
Item
date
C1519255 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
C2826658 (UMLS CUI [1,2])
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
Date of Death
Item
date
C1148348 (UMLS CUI [1])
CL Item
(1)
(Comment:en)
CL Item
(2)
(Comment:en)
CL Item
(3)
(Comment:en)
CL Item
(X)
(Comment:en)
CL Item
(1)
(Comment:en)
CL Item
(2)
(Comment:en)
CL Item
(3)
(Comment:en)
CL Item
(X)
(Comment:en)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(X)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(X)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
Relationship investigational product
Item
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Did the subject withdraw from study as a result of this AE?
Item
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Duration of AE if < 24 hours
Item
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
integer
C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
SAE Causation
Item
boolean
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event
Item
boolean
C1519255 (UMLS CUI [1])
investigational product
Item
text
C0304229 (UMLS CUI [1])
Serious Adverse Event Intensity changes
Item
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
Start Date of event segment
Item
date
C2697888 (UMLS CUI [1])
Start Time of event segment
Item
time
C2697889 (UMLS CUI [1])
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
Seriousness Other
Item
text
C1710056 (UMLS CUI [1])
CM Sequence Number
Item
text
C2348184 (UMLS CUI [1])
Drug name
Item
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
text
C2826819 (UMLS CUI [1])
Dose
Item
text
C3174092 (UMLS CUI [1])
CL Item
(ACTU)
CL Item
(AMP)
CL Item
(AP)
CL Item
(BT)
CL Item
(CAP)
CL Item
(CC)
CL Item
(031)
CL Item
(002)
CL Item
(025)
CL Item
(028)
CL Item
(IUML)
CL Item
(011)
CL Item
(LM)
CL Item
(LOZ)
CL Item
(MEGU)
CL Item
(004)
CL Item
(004)
CL Item
(008)
CL Item
(MCG/KG/MIN)
CL Item
(MCG/MIN)
CL Item
(013)
CL Item
(029)
CL Item
(MEQ24)
CL Item
(003)
CL Item
(MGPER)
CL Item
(MGH)
CL Item
(007)
CL Item
(MGKH)
CL Item
(MGKM)
CL Item
(009)
CL Item
(MGML)
CL Item
(012)
CL Item
(MLH)
CL Item
(MLM)
CL Item
(023)
CL Item
(027)
CL Item
(MAC)
CL Item
(NEB)
CL Item
(PAT)
CL Item
(030)
CL Item
(PUFF)
CL Item
(SAC)
CL Item
(SPR)
CL Item
(SUP)
CL Item
(TBS)
CL Item
(TAB)
CL Item
(TSP)
CL Item
(UNT)
CL Item
(U)
CL Item
(VIA)
CL Item
(2W)
CL Item
(2W)
CL Item
(4W)
CL Item
(5D)
CL Item
(5W)
CL Item
(AC)
CL Item
(2D)
CL Item
(CO)
CL Item
(FO)
CL Item
(Q3W)
CL Item
(Q3M)
CL Item
(AD)
CL Item
(1N)
CL Item
(MO)
CL Item
(WE)
CL Item
(1D)
CL Item
(1S)
CL Item
(PC)
CL Item
(PRN)
CL Item
(12D)
CL Item
(Q3D)
CL Item
(Q4D)
CL Item
(6D)
CL Item
(4D)
CL Item
(3D)
CL Item
(2D)
CL Item
(1M)
CL Item
(24D)
CL Item
(4D)
CL Item
(1N)
CL Item
(3D)
CL Item
(U)
CL Item
(047)
C0229118 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(008)
C0014537 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(GT)
C0017196 (UMLS CUI-1)
C0041281 (UMLS CUI-2)
(Comment:en)
C0041281 (UMLS CUI-2)
(Comment:en)
CL Item
(055)
C0004048 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(INJ)
C1272883 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(013)
C0694634 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(IBU)
C0230212 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(026)
C1512954 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(030)
C0442117 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(045)
C0442118 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(031)
CL Item
(IOS)
CL Item
(033)
CL Item
(037)
CL Item
(015)
CL Item
(042)
CL Item
(045)
CL Item
(048)
CL Item
(054)
CL Item
(058)
CL Item
(060)
CL Item
(061)
CL Item
(062)
CL Item
(065)
CL Item
(067)
Start Date
Item
date
C0808070 (UMLS CUI [1])
Ongoing medication
Item
boolean
C2826666 (UMLS CUI [1])
End date medication
Item
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Primary Indication
Item
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Modified reported term
Item
text
C2826819 (UMLS CUI [1])
CL Item
(2)
CL Item
(T)
CL Item
(1)
Lab Sequence Number
Item
text
C2348184 (UMLS CUI [1])
CL Item
(Activated partial thromboplastin time)
C0030605 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(Alanine aminotransferase)
C0201899 (UMLS CUI-1)
C0201836 (UMLS CUI-2)
(Comment:en)
C0201836 (UMLS CUI-2)
(Comment:en)
CL Item
(Albumin)
C0201838 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(Alkaline phosphatase)
C0201850 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(Amylase)
C0201883 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(Aspartate aminotransferase)
C0201899 (UMLS CUI-1)
C0201836 (UMLS CUI-2)
(Comment:en)
C0201836 (UMLS CUI-2)
(Comment:en)
CL Item
(Basophils)
C0004827 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(Bicarbonate)
C0202059 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(Bilirubin)
C1278039 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(Bilirubin direct)
C0201916 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
(Bilirubin total)
CL Item
(Blood myoglobin)
CL Item
(Blood pH)
CL Item
(Blood pressure)
CL Item
(Blood urea nitrogen)
CL Item
(Body temperature)
CL Item
(Calcium)
CL Item
(CD4 lymphocytes)
CL Item
(CD8 lymphocytes)
CL Item
(Chloride)
CL Item
(Cholesterol total)
CL Item
(C-reactive protein)
CL Item
(Creatine)
CL Item
(Creatine phosphokinase)
CL Item
(Creatine phosphokinase MB)
CL Item
(Creatinine)
CL Item
(Creatinine clearance)
CL Item
(Diastolic blood pressure)
CL Item
(Eosinophils)
CL Item
(Erythrocyte sedimentation rate)
CL Item
(Fasting blood glucose)
CL Item
(FEV 1)
CL Item
(Gamma-glutamyltransferase)
CL Item
(HbA1c)
CL Item
(HBV-DNA decreased)
CL Item
(HBV-DNA increased)
CL Item
(Heart rate)
CL Item
(Hematocrit)
CL Item
(Hemoglobin)
CL Item
(High density lipoprotein)
CL Item
(HIV viral load)
CL Item
(INR)
CL Item
(Lactic dehydrogenase)
CL Item
(Lipase)
CL Item
(Low density lipoprotein)
CL Item
(Lymphocytes)
CL Item
(Magnesium)
CL Item
(Mean cell hemoglobin concentration)
CL Item
(Mean corpuscular hemoglobin)
CL Item
(Mean corpuscular volume)
CL Item
(Monocytes)
CL Item
(Neutrophils)
CL Item
(Oxygen saturation)
CL Item
(pCO2)
CL Item
(pH)
CL Item
(Phosphate)
CL Item
(Platelet count)
CL Item
(pO2)
CL Item
(Potassium)
CL Item
(Protein total)
CL Item
(Prothrombin time)
CL Item
(Red blood cell count)
CL Item
(Respiratory rate)
CL Item
(Reticulocyte count)
CL Item
(Serum glucose)
CL Item
(Serum uric acid)
CL Item
(Sodium)
CL Item
(Systolic blood pressure)
CL Item
(Thrombin time)
CL Item
(Total lung capacity)
CL Item
(Triglycerides)
CL Item
(Troponin)
CL Item
(Troponin I)
CL Item
(Troponin T)
CL Item
(Urine myoglobin)
CL Item
(Urine pH)
CL Item
(Vital capacity)
CL Item
(White blood cell count)
Test Date
Item
date
C2826247 (UMLS CUI [1])
Test Result
Item
text
C0456984 (UMLS CUI [1])
Test Units
Item
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
text
C2700150 (UMLS CUI [1])
Normal High Range
Item
text
C2700149 (UMLS CUI [1])
Relevant diagnostic results not noted above
Item
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
(N)
CL Item
(Y)
CL Item
(U)
CL Item
(X)
Drug
Item
text
C0013227 (UMLS CUI [1])
start date
Item
date
C0808070 (UMLS CUI [1])
stop date
Item
date
C0806020 (UMLS CUI [1])
Regimen
Item
text
C1276413 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
General narrative comments
Item
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
incomplete SAE data GSK Safety
Item
boolean
C1710056 (UMLS CUI [1])
Receipt by GSK date
Item
date
C2985846 (UMLS CUI [1])
Receipt by GSK date
Item
date
C2985846 (UMLS CUI [1])
serious SAE
Item
boolean
C1519255 (UMLS CUI [1])
SAE Sequence Number
Item
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Version Number
Item
integer
C2985700 (UMLS CUI [1])
Case ID
Item
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
text
C0805701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,2])
Email Flag
Item
text
C0013849 (UMLS CUI [1])
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