ID

32048

Description

This ODM file contains the form for documentation of the vital signs, the 12-lead ecg, the laboratory testing and the pregnancy test. To be assessed at follow-up visit. 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 (1)
  1. 10/15/18 10/15/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 15, 2018

DOI

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License

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

English

Vital Signs, 12-Lead ECG, Laboratory Tests and Pregnancy Test (Follow-up Visit)

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Vital SIgns
Description

Vital SIgns

Alias
UMLS CUI-1
C0518766
Date
Description

Date of examination of the vital signs

Data type

date

Alias
UMLS CUI [1]
C2826644
Time
Description

Time of the examination of the vital signs

Data type

time

Alias
UMLS CUI [1]
C2826762
Blood pressure (systolic)
Description

Sitting

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (diastolic)
Description

Sitting

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start date of ECG
Description

Start date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start time of ECG
Description

Start time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Result of the ECG (check one)
Description

Complete additional ECG Abnormalities page if clinically significant abnormalities are present.

Data type

text

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Laboratory Tests - Clinical Chemistry, Haematology
Description

Laboratory Tests - Clinical Chemistry, Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-3
C0018941
Was a blood sample taken for the clinical laboratory tests?
Description

Was a blood sample taken for the clinical laboratory tests?

Data type

text

Alias
UMLS CUI [1]
C0005834
If Yes, Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Pregnancy Test (Complete for Female Subjects Only)
Description

Pregnancy Test (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C0032976
Date sample taken
Description

Date of pregnancy test

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Result of the pregnancy test
Description

Result of the pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0427777
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Similar models

Vital Signs, 12-Lead ECG, Laboratory Tests and Pregnancy Test (Follow-up Visit)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Vital SIgns
C0518766 (UMLS CUI-1)
Date of examination of the vital signs
Item
Date
date
C2826644 (UMLS CUI [1])
Time of the examination of the vital signs
Item
Time
time
C2826762 (UMLS CUI [1])
Systolic blood pressure
Item
Blood pressure (systolic)
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure (diastolic)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Start date of ECG
Item
Start date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time of ECG
Item
Start time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Result of the ECG (check one)
text
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Result of the 12-Lead ECG
Code List
Result of the ECG (check one)
CL Item
Normal ([1])
CL Item
Abnormal - not clinically significant ([2])
CL Item
Abnormal - clinically significant ([3])
Item Group
Laboratory Tests - Clinical Chemistry, Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-3)
Item
Was a blood sample taken for the clinical laboratory tests?
text
C0005834 (UMLS CUI [1])
Was a blood sample taken for the clinical laboratory tests?
Code List
Was a blood sample taken for the clinical laboratory tests?
CL Item
Yes ([Y])
CL Item
No ([N])
Date sample taken
Item
If Yes, Date sample taken
date
C1302413 (UMLS CUI [1])
Item Group
Pregnancy Test (Complete for Female Subjects Only)
C0032976 (UMLS CUI-1)
Date of pregnancy test
Item
Date sample taken
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of the pregnancy test
integer
C0427777 (UMLS CUI [1])
Result of the pregnancy test
Code List
Result of the pregnancy test
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not applicable (Not of childbearing potential) (3)
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