ID

34022

Beschreibung

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

Stichworte

Versionen (2)
  1. 09.11.18 09.11.18 -
  2. 11.01.19 11.01.19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

11. Januar 2019

DOI

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Lizenz

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

Englisch

Follow-Up: Study Conclusion

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschreibung

Patient Number

Datentyp

integer

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

Study Conclusion Data

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

Date of subject completion or withdrawal

Datentyp

date

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

Time of subject completion or withdrawal

Datentyp

time

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Was the subject withdrawn from the study?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

Was the subject withdrawn from the study?

Datentyp

boolean

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

If YES, specify primary reason for withdrawal

Datentyp

text

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

If OTHER, specify

Datentyp

text

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

Data owner should check the box when data cleaning is complete

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Office Use 1
Beschreibung

Office Use 1

Datentyp

boolean

Alias
UMLS CUI [1]
C0442603
Office Use 2
Beschreibung

Office Use 2

Datentyp

text

Alias
UMLS CUI [1]
C0442603
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Ähnliche Modelle

Follow-Up: Study Conclusion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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