ID

37720

Description

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Keywords

Versions (1)
  1. 8/20/19 8/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 20, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

English

Response Assessment

1 forms  
  1. StudyEvent: ODM
    1. Response Assessment
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Center number
Description

Study Coordinating Center, Identification number

Data type

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
TNM Staging
Description

TNM Staging

Alias
UMLS CUI-1
C3258246
T
Description

TNM clinical staging, primary tumor

Data type

text

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0677930
N
Description

TNM clinical staging, Lymph nodes

Data type

text

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0024204
M
Description

TNM clinical staging, Neoplasm Metastasis

Data type

text

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0027627
Tumor size - H
Description

Tumor size, Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0489786
cm
Tumor size - W
Description

Tumor size, Width

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0487742
cm
Tumor size - D
Description

Tumor size, Diameter

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1301886
cm
Ulceration
Description

TNM clinical staging, Ulceration

Data type

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C3887532
Pathological Staging
Description

Pathological Staging

Alias
UMLS CUI-1
C0007113
UMLS CUI-2
C0443276
Pathological Staging
Description

Rectal Carcinoma, Pathological staging

Data type

text

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0443276
Sphincter Preservation
Description

Sphincter Preservation

Alias
UMLS CUI-1
C0007113
UMLS CUI-2
C1409894
UMLS CUI-3
C1514402
Was the Sphincter Preserved?
Description

Rectal Carcinoma, Sphincter, Preservation technique

Data type

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C1409894
UMLS CUI [1,3]
C1514402
Back to the top of the page

Similar models

Response Assessment

1 forms
  1. StudyEvent: ODM
    1. Response Assessment
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
TNM Staging
C3258246 (UMLS CUI-1)
TNM clinical staging, primary tumor
Item
T
text
C3258246 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
TNM clinical staging, Lymph nodes
Item
N
text
C3258246 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
TNM clinical staging, Neoplasm Metastasis
Item
M
text
C3258246 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Tumor size, Height
Item
Tumor size - H
float
C0475440 (UMLS CUI [1,1])
C0489786 (UMLS CUI [1,2])
Tumor size, Width
Item
Tumor size - W
float
C0475440 (UMLS CUI [1,1])
C0487742 (UMLS CUI [1,2])
Tumor size, Diameter
Item
Tumor size - D
float
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
TNM clinical staging, Ulceration
Item
Ulceration
boolean
C3258246 (UMLS CUI [1,1])
C3887532 (UMLS CUI [1,2])
Item Group
Pathological Staging
C0007113 (UMLS CUI-1)
C0443276 (UMLS CUI-2)
Item
Pathological Staging
text
C0007113 (UMLS CUI [1,1])
C0443276 (UMLS CUI [1,2])
Rectal Carcinoma, Pathological staging
Code List
Pathological Staging
CL Item
No cancer cells present (1)
CL Item
Few cancer cells present, - >= 75% Necrosis (2)
CL Item
Large tumor, < 75% Necrosis (3)
Item Group
Sphincter Preservation
C0007113 (UMLS CUI-1)
C1409894 (UMLS CUI-2)
C1514402 (UMLS CUI-3)
Rectal Carcinoma, Sphincter, Preservation technique
Item
Was the Sphincter Preserved?
boolean
C0007113 (UMLS CUI [1,1])
C1409894 (UMLS CUI [1,2])
C1514402 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial