ID

31912

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-10-08 2018-10-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 oktober 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396

Engelsk

Vital Signs Day 1

1 Formulär  
  1. StudyEvent: ODM
    1. Vital Signs Day 1
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
Visit Type
Beskrivning

Visit Type

Datatyp

integer

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

Vital Signs pre-dose

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

Date of measurement of the vital signs

Datatyp

date

Alias
UMLS CUI [1]
C2826644
Time
Beskrivning

Time of measurement of the vital signs

Datatyp

time

Alias
UMLS CUI [1]
C2826762
Blood pressure Systolic
Beskrivning

Sitting

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure Diastolic
Beskrivning

Sitting

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
Vital Signs Post-Dose
Beskrivning

Vital Signs Post-Dose

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

Vital Signs Assessment Date

Datatyp

date

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

Planned Relative Time

Datatyp

integer

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

vital signs time

Datatyp

time

Alias
UMLS CUI [1]
C2826762
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Tillbaka till toppen

Similar models

Vital Signs Day 1

1 Formulär
  1. StudyEvent: ODM
    1. Vital Signs Day 1
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
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial