ID

27677

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 26, 2017

DOI

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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

Alias
UMLS CUI-1
C1320722
Session number
Description

Session number

Data type

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
TNM Staging History
Description

TNM Staging History

Alias
UMLS CUI-1
C3258246
Date of Stage Determination
Description

Date of Staging

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0027646
TNM Stage: Primary Tumor
Description

Staging of Prostate Cancer (TNM) (1992)

Data type

text

Alias
UMLS CUI [1]
C3260341
TNM Stage: Regional Lymph Nodes
Description

Staging of Prostate Cancer (TNM) (1992)

Data type

text

Alias
UMLS CUI [1,1]
C1275866
UMLS CUI [1,2]
C3846420
TNM Stage: Distant Metastases
Description

Staging of Prostate Cancer (TNM) (1992)

Data type

text

Alias
UMLS CUI [1]
C3258247
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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
C1320722 (UMLS CUI-1)
Session number
Item
Session number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
TNM Staging History
C3258246 (UMLS CUI-1)
Date of Staging
Item
Date of Stage Determination
date
C0011008 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
Item
TNM Stage: Primary Tumor
text
C3260341 (UMLS CUI [1])
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
C1275866 (UMLS CUI [1,1])
C3846420 (UMLS CUI [1,2])
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
C3258247 (UMLS CUI [1])
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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