ID

34022

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

  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

Follow-Up: Study Conclusion

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
Study Conclusion Data
Beschrijving

Study Conclusion Data

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Beschrijving

Date of subject completion or withdrawal

Datatype

date

Alias
UMLS CUI [1]
C2983670
UMLS CUI [2]
C2349954
Time of subject completion or withdrawal
Beschrijving

Time of subject completion or withdrawal

Datatype

time

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C1522314
UMLS CUI [2]
C2349954
Was the subject withdrawn from the study?
Beschrijving

Was the subject withdrawn from the study?

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
If YES, specify primary reason for withdrawal
Beschrijving

If YES, specify primary reason for withdrawal

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [2]
C2348235
If OTHER, specify
Beschrijving

If OTHER, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Case book ready for signature
Beschrijving

Data owner should check the box when data cleaning is complete

Datatype

text

Alias
UMLS CUI [1]
C1519316
Office Use 1
Beschrijving

Office Use 1

Datatype

boolean

Alias
UMLS CUI [1]
C0442603
Office Use 2
Beschrijving

Office Use 2

Datatype

text

Alias
UMLS CUI [1]
C0442603

Similar models

Follow-Up: Study Conclusion

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
Study Conclusion Data
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
C2349954 (UMLS CUI [2])
Time of subject completion or withdrawal
Item
Time of subject completion or withdrawal
time
C0008972 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C2349954 (UMLS CUI [2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If YES, specify primary reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Code List
If YES, specify primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (5)
CL Item
Other (6)
If OTHER, specify
Item
If OTHER, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Case book ready for signature
text
C1519316 (UMLS CUI [1])
Code List
Case book ready for signature
CL Item
Yes (1)
Office Use 1
Item
Office Use 1
boolean
C0442603 (UMLS CUI [1])
Item
Office Use 2
text
C0442603 (UMLS CUI [1])
Code List
Office Use 2
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)

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