ID

34022

Description

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

Keywords

Versions (2)
  1. 11/9/18 11/9/18 -
  2. 1/11/19 1/11/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 11, 2019

DOI

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License

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

English

Follow-Up: Study Conclusion

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Study Conclusion Data
Description

Study Conclusion Data

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

Date of subject completion or withdrawal

Data type

date

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

Time of subject completion or withdrawal

Data type

time

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Was the subject withdrawn from the study?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

Was the subject withdrawn from the study?

Data type

boolean

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

If YES, specify primary reason for withdrawal

Data type

text

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

If OTHER, specify

Data type

text

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

Data owner should check the box when data cleaning is complete

Data type

text

Alias
UMLS CUI [1]
C1519316
Office Use 1
Description

Office Use 1

Data type

boolean

Alias
UMLS CUI [1]
C0442603
Office Use 2
Description

Office Use 2

Data type

text

Alias
UMLS CUI [1]
C0442603
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Similar models

Follow-Up: Study Conclusion

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
If YES, specify primary reason for withdrawal
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])
Case book ready for signature
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])
Office Use 2
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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