ID

31912

Description

This ODM file contains the form to document the vital signs. To be assessed at Day 1 of Period 1 and 2. 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. 10/8/18 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 ID 106396

English

Vital Signs Day 1

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs Day 1
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
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1]
C3641100
Vital Signs pre-dose
Description

Vital Signs pre-dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Date
Description

Date of measurement of the vital signs

Data type

date

Alias
UMLS CUI [1]
C2826644
Time
Description

Time of measurement 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
Vital Signs Post-Dose
Description

Vital Signs Post-Dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
Date
Description

Vital Signs Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2985720
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time
Description

vital signs time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

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

Vital Signs Day 1

1 forms
  1. StudyEvent: ODM
    1. Vital Signs Day 1
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
Visit Type
integer
C3641100 (UMLS CUI [1])
Visit Type
Code List
Visit Type
CL Item
Day 1 of Period 1 (1)
CL Item
Day 1 of Period 2 (2)
Item Group
Vital Signs pre-dose
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Date of measurement of the vital signs
Item
Date
date
C2826644 (UMLS CUI [1])
Time of measurement of the vital signs
Item
Time
time
C2826762 (UMLS CUI [1])
Blood pressure systolic
Item
Blood pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Vital Signs Assessment Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
15 minutes post-dose (1)
CL Item
30 minutes post-dose (2)
CL Item
45 minutes post-dose (3)
CL Item
60 minutes post-dose (4)
CL Item
75 minutes post-dose (5)
CL Item
90 minutes post-dose (6)
CL Item
1.75 hours post-dose (7)
CL Item
2 hours post-dose (8)
CL Item
2.5 hours post-dose (9)
CL Item
3 hours post-dose (10)
CL Item
3.5 hours post-dose (11)
CL Item
4 hours post-dose (12)
CL Item
4.5 hours post-dose (13)
CL Item
5 hours post-dose (14)
CL Item
5.25 hours post-dose (15)
CL Item
5.5 hours post-dose (16)
CL Item
5.75 hours post-dose (17)
CL Item
6 hours post-dose (18)
CL Item
6 hours post-dose (19)
CL Item
6.5 hours post-dose (20)
CL Item
6.75 hours post-dose (21)
CL Item
7 hours post-dose (22)
CL Item
7.25 hours post-dose (23)
CL Item
7.5 hours post-dose (24)
CL Item
7.75 hours post-dose (25)
CL Item
8 hours post-dose (26)
CL Item
8.5 hours post-dose (27)
CL Item
9 hours post-dose (28)
CL Item
9.5 hours post-dose (29)
CL Item
10 hours post-dose (30)
vital signs time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
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