ID

27673

Description

Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate CRF Seiten: 934-977

Keywords

Versions (2)
  1. 11/13/17 11/13/17 -
  2. 11/26/17 11/26/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 26, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Contact #2 Year 2 GSK study Prostatic neoplasms NCT00883909

English

Visit 7 GSK-AVA100468 NCT00381238

1 forms  
formality
Description

formality

Protocol Identifier: AVA100468
Description

Protocol Identifier

Data type

boolean

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood pressure measurement
Description

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure measurement
Description

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Central Laboratory (Non fasting samples)
Description

Central Laboratory (Non fasting samples)

Alias
UMLS CUI-1
C0022885
Central Laboratory (Non fasting samples)
Description

Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.

Data type

text

Alias
UMLS CUI [1]
C0022885
Date samples taken
Description

Date samples taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Adverse events Concomitant medications
Description

Adverse events Concomitant medications

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
Concomitant medications
Description

Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.

Data type

text

Alias
UMLS CUI [1]
C2347852
Adverse events
Description

Record details of any new non-serious adverse events / serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events / Serious Adverse Events section.

Data type

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Physical Examination
Description

Perform a physical examination on the subject, including auscultation of heart and lungs. If any abnormalties are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.

Data type

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Description

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Pedal Oedema size
Description

Note: worst affected ankle

Data type

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0456389
Pedal Oedema side
Description

Note: worst affected ankle

Data type

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0441987
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Dose
Description

Dose

Data type

text

Measurement units
  • mg
Alias
UMLS CUI [1]
C3174092
mg
IP Container No.
Description

IP Container No

Data type

text

Alias
UMLS CUI [1]
C0180098
Compliance
Description

Compliance

Alias
UMLS CUI-1
C1321605
Total number of Tablets Dispensed
Description

Total number of Tablets Dispensed

Data type

text

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Total number of Tablets Returned
Description

Total number of Tablets Returned

Data type

text

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Has the subject missed investigational product for >7 consecutive days?
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0013227
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Similar models

Visit 7 GSK-AVA100468 NCT00381238

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
formality
Protocol Identifier
Item
Protocol Identifier: AVA100468
boolean
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure measurement
text
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure measurement
text
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Central Laboratory (Non fasting samples)
C0022885 (UMLS CUI-1)
Central Laboratory (Non fasting samples)
Item
Central Laboratory (Non fasting samples)
text
C0022885 (UMLS CUI [1])
Date samples taken
Item
Date samples taken
date
C1302413 (UMLS CUI [1])
Item Group
Adverse events Concomitant medications
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Concomitant medications
Item
Concomitant medications
text
C2347852 (UMLS CUI [1])
Adverse events
Item
Adverse events
text
C0877248 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination
Item
Physical Examination
text
C0031809 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Item
Pedal Oedema size
integer
C0574002 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Pedal Oedema
Code List
Pedal Oedema size
CL Item
<1mm (1)
CL Item
1-2mm (2)
CL Item
3-5mm (3)
CL Item
6-10mm (4)
CL Item
>10mm (5)
Item
Pedal Oedema side
integer
C0574002 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Pedal Oedema
Code List
Pedal Oedema side
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
IP Container No
Item
IP Container No.
text
C0180098 (UMLS CUI [1])
Item Group
Compliance
C1321605 (UMLS CUI-1)
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
text
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
text
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Compliance
Item
Has the subject missed investigational product for >7 consecutive days?
boolean
C1321605 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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