ID

38562

Description

Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Mots-clés

Versions (2)
  1. 20/10/2019 20/10/2019 -
  2. 24/10/2019 24/10/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

24 octobre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636

Anglais

Post Tx/WD

1 Formulaires  
  1. StudyEvent: ODM
    1. Post Tx/WD
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Description

Study Site

Type de données

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient name

Type de données

text

Alias
UMLS CUI [1]
C1299487
Patient No
Description

Patients, Identification number

Type de données

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Description

Date of visit; Assessment Date

Type de données

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Status of Medications
Description

Status of Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0449438
Were any medications recorded on the In-Clinic Medications Taken Diary?
Description

Concomitant Agent

Type de données

boolean

Alias
UMLS CUI [1]
C2347852
Medications Recorded In-Clinic
Description

Medications Recorded In-Clinic

Alias
UMLS CUI-1
C2347852
Sequence Number
Description

Concomitant Agent, Sequence Number

Type de données

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Drug Name (Trade Name preferred)
Description

Concomitant Agent, Medication name

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Modified reported term
Description

Concomitant Agent, Medication name, Reported Term

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
UMLS CUI [1,3]
C2826302
GSK Drug synonym
Description

Concomitant Agent, Pharmaceutical Preparations, Synonym

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0871468
GSK Drug Collection code
Description

Concomitant Agent, Code

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
Failed coding
Description

Concomitant Agent, Code, Failed

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Date Taken
Description

Concomitant Agent, Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0011008
Time Taken
Description

Concomitant Agent, Time

Type de données

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0040223
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Body Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Type de données

float

Unités de mesure
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Blood pressure(1st Reading) - Systolic
Description

Systolic Pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(1st Reading) - Diastolic
Description

Diastolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Blood pressure(2nd Reading) - Systolic
Description

Systolic Pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(2nd Reading) - Diastolic
Description

Diastolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Blood pressure(3rd Reading) - Systolic
Description

Systolic Pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(3rd Reading) - Diastolic
Description

Diastolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Average of the lowest two blood pressure readings - Systolic
Description

Systolic Pressure, Low, Average

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992
mmHg
Average of the lowest two blood pressure readings - Diastolic
Description

Diastolic blood pressure, Low, Average

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992
mmHg
Average of the lowest two blood pressure readings at Screening visit - Systolic
Description

Systolic Pressure, Low, Average, Screening procedure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992
UMLS CUI [1,4]
C0220908
mmHg
Average of the lowest two blood pressure readings at Screening visit - Diastolic
Description

Diastolic blood pressure, Low, Average, Screening procedure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992C0220908
mmHg
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

12 lead ECG, Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Heart rate
Description

12 lead ECG, Heart rate

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Description

12 lead ECG, P-R Interval

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

12 lead ECG, QRS complex duration

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

12 lead ECG, QT Interval

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Description

12 lead ECG, Electrocardiogram QT corrected interval

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Is this a repeat ECG?
Description

12 lead ECG, Repeat

Type de données

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205341
Yes, specify reason repeated
Description

12 lead ECG, Repeat, Reason and justification

Type de données

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0566251
Result of the ECG
Description

12 lead ECG, Result

Type de données

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Change in ECG Result
Description

12 lead ECG, Result, Change status

Type de données

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0443172
Was there a clinically significant change from baseline?
Description

12 lead ECG, Result, Change status, Clinical Significance

Type de données

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0443172
UMLS CUI [1,4]
C2826293
QRS Axis
Description

12 lead ECG, QRS Axis

Type de données

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429012
RR interval
Description

12 lead ECG, RR interval

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0489636
msec
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Description

Liver, Adverse Event, Evaluation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0220825
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Similar models

Post Tx/WD

1 Formulaires
  1. StudyEvent: ODM
    1. Post Tx/WD
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Status of Medications
C2347852 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Concomitant Agent
Item
Were any medications recorded on the In-Clinic Medications Taken Diary?
boolean
C2347852 (UMLS CUI [1])
Item Group
Medications Recorded In-Clinic
C2347852 (UMLS CUI-1)
Concomitant Agent, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Agent, Medication name
Item
Drug Name (Trade Name preferred)
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Agent, Medication name, Reported Term
Item
Modified reported term
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
Concomitant Agent, Pharmaceutical Preparations, Synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
Concomitant Agent, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Concomitant Agent, Code, Failed
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Concomitant Agent, Date in time
Item
Date Taken
date
C2347852 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Concomitant Agent, Time
Item
Time Taken
time
C2347852 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(1st Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(1st Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(2nd Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(2nd Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(3rd Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(3rd Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Systolic Pressure, Low, Average
Item
Average of the lowest two blood pressure readings - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Diastolic blood pressure, Low, Average
Item
Average of the lowest two blood pressure readings - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Systolic Pressure, Low, Average, Screening procedure
Item
Average of the lowest two blood pressure readings at Screening visit - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Diastolic blood pressure, Low, Average, Screening procedure
Item
Average of the lowest two blood pressure readings at Screening visit - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992C0220908 (UMLS CUI [1,3])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, P-R Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
12 lead ECG, Repeat
Item
Is this a repeat ECG?
boolean
C0430456 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item
Yes, specify reason repeated
text
C0430456 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
12 lead ECG, Repeat, Reason and justification
Code List
Yes, specify reason repeated
CL Item
Safety (1)
CL Item
Other (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, clinically significant  (3)
CL Item
No result (not available) (4)
Item
Change in ECG Result
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
12 lead ECG, Result
Code List
Change in ECG Result
CL Item
Clinically significant change from [protocol specific timepoint] favourable (1)
CL Item
Clinically significant change from [protocol specified timepoint] unfavourable  (2)
CL Item
No change or insignificant change from [protocol specified timepoint] (3)
CL Item
No result (not available) (4)
Item
Was there a clinically significant change from baseline?
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
12 lead ECG, Result
Code List
Was there a clinically significant change from baseline?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (3)
12 lead ECG, QRS Axis
Item
QRS Axis
text
C0430456 (UMLS CUI [1,1])
C0429012 (UMLS CUI [1,2])
12 lead ECG, RR interval
Item
RR interval
integer
C0430456 (UMLS CUI [1,1])
C0489636 (UMLS CUI [1,2])
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Liver, Adverse Event, Evaluation
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Retour au début de la page 

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