ID

34023

Beskrivning

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Nyckelord

Versioner (2)
  1. 2018-11-09 2018-11-09 -
  2. 2019-01-11 2019-01-11 -
Rättsinnehavare

GSK group of companies

Uppladdad den

11 januari 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

Engelsk

Follow-Up: Pregnancy Information

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Beskrivning

Site

Datatyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beskrivning

Patient

Datatyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beskrivning

Patient Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Pregnancy Information
Beskrivning

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beskrivning

For each study session Pregnancy test should be done at Predose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
If YES, complete the paper Pregnancy Notification form
Beskrivning

If YES, complete the paper Pregnancy Notification form

Datatyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Pregnancy Information Part 2
Beskrivning

Pregnancy Information Part 2

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Beskrivning

If YES, complete the paper Pregnancy Notification form

Datatyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0008976
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Similar models

Follow-Up: Pregnancy Information

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
If YES, complete the paper Pregnancy Notification form
Item
If YES, complete the paper Pregnancy Notification form
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item Group
Pregnancy Information Part 2
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Did a female partner of the male subject become pregnant during the study?
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not Applicable (Check Not Applicable if female partner not of childbearing or no female partner) (3)
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