ID

31848

Beskrivning

This ODM file contains the form to collect data about the substance use of the patient. To be assessed at Screening. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Nyckelord

Versioner (1)
  1. 2018-10-03 2018-10-03 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 oktober 2018

DOI

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Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396

Engelsk

Substance Use

1 Formulär  
  1. StudyEvent: ODM
    1. Substance Use
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Alcohol Intake
Beskrivning

Alcohol Intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Beskrivning

Alcohol consumption

Datatyp

text

Alias
UMLS CUI [1]
C0001948
If Yes, record the average number of units of alcohol1 consumed per week
Beskrivning

ALCOHOL CONVERTER 1 unit of alcohol in US = 1.5oz hard liquor, 1 beer, 4oz wine Round up/down to the nearest integer

Datatyp

integer

Måttenheter
  • units/week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units/week
History of Tobacco Use
Beskrivning

History of Tobacco Use

Alias
UMLS CUI-1
C0543414
Is the subject currently using a nicotine oral regimen or topical application (e.g., gum, patches, etc.)?
Beskrivning

Nicotine oral regimen or topical application

Datatyp

text

Alias
UMLS CUI [1]
C1270916
UMLS CUI [2]
C3213077
What is the subject’s history of tobacco use?
Beskrivning

DEFINITIONS • Never smoked Never smoked/used tobacco • Current smoker Currently smoking/using tobacco or has smoked/used tobacco within 6 months of screening visit • Former smoker Previously smoked/used tobacco and has not smoked/used tobacco for at least 6 months prior to screening visit

Datatyp

integer

Alias
UMLS CUI [1]
C0543414
if current or former smoker: When did the subjet last smoke/use tobacco?
Beskrivning

Last smoke

Datatyp

date

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0011008
if current or former smoker: Average number of cigarettes smoked per day?
Beskrivning

CONVERTER FOR TOBACCO PRODUCTS 1 cigar = 7 cigarettes 1 gram (or 0.03 oz.) of tobacco = 1 cigarette

Datatyp

integer

Måttenheter
  • cigarettes/day
Alias
UMLS CUI [1,1]
C3694146
UMLS CUI [1,2]
C1510992
cigarettes/day
If current or former smoker: Number of years during which the subject has smoked?
Beskrivning

Number of years smoking

Datatyp

integer

Måttenheter
  • years
Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
years
If current or former smoker: Number of pack years?
Beskrivning

CALCULATION FOR NUMBER OF PACK YEARS Average number of cigarettes smoked per day x number of years smoked 20 Round up/down to the nearest integer

Datatyp

integer

Måttenheter
  • pack years
Alias
UMLS CUI [1,1]
C1277691
UMLS CUI [1,2]
C0449788
pack years
Drug and Alcohol Screen
Beskrivning

Drug and Alcohol Screen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0038586
UMLS CUI-3
C0948726
Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1302413
Time sample taken
Beskrivning

Time sample taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Cocaine
Beskrivning

If positive, exclude subject from the study.

Datatyp

integer

Alias
UMLS CUI [1]
C0009170
Amphetamines
Beskrivning

If positive, exclude subject from the study.

Datatyp

integer

Alias
UMLS CUI [1]
C0002667
Benzodiazepines
Beskrivning

If positive, exclude subject from the study.

Datatyp

integer

Alias
UMLS CUI [1]
C0005064
Cannabinoids
Beskrivning

If positive, exclude subject from the study.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0936079
UMLS CUI [1,2]
C0870883
Opiates
Beskrivning

If positive, exclude subject from the study.

Datatyp

integer

Alias
UMLS CUI [1]
C0376196
Barbiturates
Beskrivning

If positive, exclude subject from the study.

Datatyp

integer

Alias
UMLS CUI [1]
C0004745
Alcohol
Beskrivning

If any of the above are positive, exclude subject from the study.

Datatyp

integer

Alias
UMLS CUI [1]
C0202304
Laboratory Tests - Urine Cotinine
Beskrivning

Laboratory Tests - Urine Cotinine

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1697737
Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Results
Beskrivning

Urine Cotinine test results

Datatyp

integer

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1697737
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Similar models

Substance Use

1 Formulär
  1. StudyEvent: ODM
    1. Substance Use
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Alcohol Intake
C0001948 (UMLS CUI-1)
Item
Does the subject consume alcohol?
text
C0001948 (UMLS CUI [1])
Alcohol consumption
Code List
Does the subject consume alcohol?
CL Item
No (N)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (Y)
C1705108 (UMLS CUI-1)
(Comment:en)
Average number of units of alcohol consumed per week
Item
If Yes, record the average number of units of alcohol1 consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
History of Tobacco Use
C0543414 (UMLS CUI-1)
Item
Is the subject currently using a nicotine oral regimen or topical application (e.g., gum, patches, etc.)?
text
C1270916 (UMLS CUI [1])
C3213077 (UMLS CUI [2])
Alcohol consumption
Code List
Is the subject currently using a nicotine oral regimen or topical application (e.g., gum, patches, etc.)?
CL Item
No (N)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (Y)
C1705108 (UMLS CUI-1)
(Comment:en)
Item
What is the subject’s history of tobacco use?
integer
C0543414 (UMLS CUI [1])
tobacco use
Code List
What is the subject’s history of tobacco use?
CL Item
Current smoker (2)
(Comment:en)
CL Item
Former smoker (3)
(Comment:en)
CL Item
Never smoked (1)
(Comment:en)
Last smoke
Item
if current or former smoker: When did the subjet last smoke/use tobacco?
date
C0543414 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Cigarettes per day
Item
if current or former smoker: Average number of cigarettes smoked per day?
integer
C3694146 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
Number of years smoking
Item
If current or former smoker: Number of years during which the subject has smoked?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of pack years
Item
If current or former smoker: Number of pack years?
integer
C1277691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
Drug and Alcohol Screen
C0373483 (UMLS CUI-1)
C0038586 (UMLS CUI-2)
C0948726 (UMLS CUI-3)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Cocaine
integer
C0009170 (UMLS CUI [1])
Cocaine
Code List
Cocaine
CL Item
positive (1)
CL Item
negative (2)
Item
Amphetamines
integer
C0002667 (UMLS CUI [1])
Cocaine
Code List
Amphetamines
CL Item
positive (1)
CL Item
negative (2)
Item
Benzodiazepines
integer
C0005064 (UMLS CUI [1])
Cocaine
Code List
Benzodiazepines
CL Item
positive (1)
CL Item
negative (2)
Item
Cannabinoids
integer
C0936079 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
Cocaine
Code List
Cannabinoids
CL Item
positive (1)
CL Item
negative (2)
Item
Opiates
integer
C0376196 (UMLS CUI [1])
Cocaine
Code List
Opiates
CL Item
positive (1)
CL Item
negative (2)
Item
Barbiturates
integer
C0004745 (UMLS CUI [1])
Cocaine
Code List
Barbiturates
CL Item
positive (1)
CL Item
negative (2)
Item
Alcohol
integer
C0202304 (UMLS CUI [1])
Cocaine
Code List
Alcohol
CL Item
positive (1)
CL Item
negative (2)
Item Group
Laboratory Tests - Urine Cotinine
C0022885 (UMLS CUI-1)
C1697737 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Results
integer
C1254595 (UMLS CUI [1,1])
C1697737 (UMLS CUI [1,2])
Results
Code List
Results
CL Item
Positive (1)
(Comment:en)
CL Item
Negative (2)
(Comment:en)
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