ID

32048

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-10-15 2018-10-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 oktober 2018

DOI

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Licens

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

Engelsk

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

1 Formulär  
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
Vital SIgns
Beskrivning

Vital SIgns

Alias
UMLS CUI-1
C0518766
Date
Beskrivning

Date of examination of the vital signs

Datatyp

date

Alias
UMLS CUI [1]
C2826644
Time
Beskrivning

Time of the examination 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
12-Lead ECG
Beskrivning

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start date of ECG
Beskrivning

Start date of ECG

Datatyp

date

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

Start time of ECG

Datatyp

time

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

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

Datatyp

text

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

Laboratory Tests - Clinical Chemistry, Haematology

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

Was a blood sample taken for the clinical laboratory tests?

Datatyp

text

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

Date sample taken

Datatyp

date

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

Pregnancy Test (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C0032976
Date sample taken
Beskrivning

Date of pregnancy test

Datatyp

date

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

Result of the pregnancy test

Datatyp

integer

Alias
UMLS CUI [1]
C0427777
Tillbaka till toppen

Similar models

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

1 Formulär
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
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)
Tillbaka till toppen 

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