ID

34023

Beschrijving

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

Trefwoorden

Versies (2)
  1. 09-11-18 09-11-18 -
  2. 11-01-19 11-01-19 -
Houder van rechten

GSK group of companies

Geüploaded op

11 januari 2019

DOI

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Licentie

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

Engels

Follow-Up: Pregnancy Information

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Beschrijving

Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschrijving

Patient

Datatype

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschrijving

Patient Number

Datatype

integer

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

Pregnancy Information

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

For each study session Pregnancy test should be done at Predose

Datatype

boolean

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

If YES, complete the paper Pregnancy Notification form

Datatype

text

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

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?
Beschrijving

If YES, complete the paper Pregnancy Notification form

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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