ID

31909

Description

This ODM-file contains a form to document the medical conditions and findings of the physical examination and vital signs. 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

Keywords

Versions (2)
  1. 10/7/18 10/7/18 -
  2. 10/8/18 10/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 8, 2018

DOI

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License

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

English

Medical conditions, physical examination and vital signs

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0009488
Diagnosis
Description

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Data type

text

Alias
UMLS CUI [1]
C0011900
Is the diagnosis current?
Description

Is the diagnosis current?

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0521116
Is the diagnosis past?
Description

Is the diagnosis past?

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1444637
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Has a physical examination been performed on the subject?
Description

physical examination

Data type

text

Alias
UMLS CUI [1]
C0031809
Was the physical examination?
Description

Examination Status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0449438
If abnormal record below
Description

abnormal physical examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0459424
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

Date of measurements

Data type

date

Alias
UMLS CUI [1]
C1320303
Time
Description

Time of measurements

Data type

time

Alias
UMLS CUI [1]
C0040223
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Blood pressure Systolic
Description

Sitting

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
Blood pressure diastolic
Description

Sitting

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
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Similar models

Medical conditions, physical examination and vital signs

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Medical Conditions
C0262926 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Is the diagnosis current?
Item
Is the diagnosis current?
boolean
C0011900 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Is the diagnosis past?
Item
Is the diagnosis past?
boolean
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Has a physical examination been performed on the subject?
text
C0031809 (UMLS CUI [1])
physical examination
Code List
Has a physical examination been performed on the subject?
CL Item
No (N)
CL Item
Yes (Y)
Item
Was the physical examination?
text
C0031809 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Examination Status
Code List
Was the physical examination?
CL Item
Normal (Normal)
(Comment:en)
CL Item
Abnormal (Abnormal)
(Comment:en)
abnormal physical examination
Item
If abnormal record below
text
C0031809 (UMLS CUI [1,1])
C0459424 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date of measurements
Item
Date
date
C1320303 (UMLS CUI [1])
Time of measurements
Item
Time
time
C0040223 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Blood pressure
Item
Blood pressure Systolic
integer
C0871470 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
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