ID

27407

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 (3)
  1. 11/13/17 11/13/17 -
  2. 11/13/17 11/13/17 -
  3. 11/26/17 11/26/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 13, 2017

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License

Creative Commons BY-NC 3.0
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TNM Staging GSK study Prostatic neoplasms NCT00883909

English

TNM Staging GSK study Prostatic neoplasms NCT00883909

1 forms  
Administrative data
Description

Administrative data

Session number
Description

Session number

Data type

integer

Subject number
Description

Subject number

Data type

text

TNM Staging History
Description

TNM Staging History

Date of Stage Determination
Description

Date of Stage Determination

Data type

date

TNM Stage: Primary Tumor
Description

Staging of Prostate Cancer (TNM) (1992)

Data type

text

TNM Stage: Regional Lymph Nodes
Description

Staging of Prostate Cancer (TNM) (1992)

Data type

text

TNM Stage: Distant Metastases
Description

Staging of Prostate Cancer (TNM) (1992)

Data type

text

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Similar models

TNM Staging GSK study Prostatic neoplasms NCT00883909

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Session number
Item
Session number
integer
Subject number
Item
Subject number
text
Item Group
TNM Staging History
Date of Stage Determination
Item
Date of Stage Determination
date
Item
TNM Stage: Primary Tumor
text
TNM Stage Primary Tumor
Code List
TNM Stage: Primary Tumor
CL Item
Nonpalpable Cancer (T1)
CL Item
Five percent or less of TURP tissue (or resected tissue) (T1a)
CL Item
More than 5% of TURP tissue (or resected tissue) (T1b)
CL Item
Nonpalpable, nonvisible cancer detected by biopsy (elevated PSA) (T1c)
CL Item
Palpable or Visible Cancer Confined Within the Capsule (T2)
CL Item
Involves 50% or less of one lobe (T2a)
CL Item
Involves more than 50% of one lobe (T2b)
CL Item
Involves both lobes (T2c)
CL Item
Local Extracapsular Extension (T3)
CL Item
T3a Unilateral extracapsular extension (T3a)
CL Item
T3b Bilateral extracapsular extension (T3b)
CL Item
Seminal vesicle invasion (T3c)
CL Item
Invasion of Adjacent Organs and Tissues (T4)
CL Item
T4a Invasion of bladder, neck, rectum, or external sphincter (T4a)
CL Item
Invasion of levator muscle or pelvic wall (T4b)
Item
TNM Stage: Regional Lymph Nodes
text
Regional Lymph Nodes
Code List
TNM Stage: Regional Lymph Nodes
CL Item
Nodal status unknown (NX)
CL Item
No lymph node involvement (N0)
CL Item
Single regional lymph node, 2cm or less in greatest dimension (N1)
CL Item
Single regional lymph node, 2 to 5cm or multiple lymph nodes 5cm or less (N2)
CL Item
Single regional lymph node, more than 5cm (N3)
Item
TNM Stage: Distant Metastases
text
TNM Stage Distant Metastases
Code List
TNM Stage: Distant Metastases
CL Item
Status unknown (MX)
CL Item
No distant metastases (M0)
CL Item
Nonregional lymph nodes (M1a)
CL Item
Bone (M1b)
CL Item
Other sites (M1c)
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