ID

37689

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

  1. 8/16/19 8/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 16, 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.

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

Study Medication

  1. StudyEvent: ODM
    1. Study Medication
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
Visit Date
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Weight/Body Surface Area
Description

Weight/Body Surface Area

Alias
UMLS CUI-1
C0005910
UMLS CUI-2
C0005902
Weight - Unit
Description

Body Weight, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1519795
Weight
Description

Body Weight

Data type

float

Body Surface Area
Description

Body Surface Area

Data type

float

Measurement units
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Topotecan Study Medication/Radiation Record
Description

Topotecan Study Medication/Radiation Record

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C1522449
Treatment Day
Description

Topotecan, Therapeutic radiology procedure, Day

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0439228
Date
Description

Topotecan; Therapeutic radiology procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0011008
Scheduled Daily Dose
Description

Topotecan; Therapeutic radiology procedure, Daily Dose, Scheduled

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0205539
mg
Actual Daily Dose
Description

Topotecan; Therapeutic radiology procedure, Daily Dose, Actual

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0237400
mg
RT Daily Dose
Description

Therapeutic radiology procedure, Daily Dose

Data type

integer

Measurement units
  • x 100Gy
Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0237400
x 100Gy

Similar models

Study Medication

  1. StudyEvent: ODM
    1. Study Medication
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])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Weight/Body Surface Area
C0005910 (UMLS CUI-1)
C0005902 (UMLS CUI-2)
Item
Weight - Unit
text
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Weight - Unit
CL Item
kg (1)
CL Item
lb (2)
Body Weight
Item
Weight
float
Body Surface Area
Item
Body Surface Area
float
C0005902 (UMLS CUI [1])
Item Group
Topotecan Study Medication/Radiation Record
C0146224 (UMLS CUI-1)
C1522449 (UMLS CUI-2)
Item
Treatment Day
text
C0146224 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
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)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22 (22)
CL Item
23 (23)
CL Item
24 (24)
CL Item
25 (25)
Topotecan; Therapeutic radiology procedure, Date in time
Item
Date
date
C0146224 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Topotecan; Therapeutic radiology procedure, Daily Dose, Scheduled
Item
Scheduled Daily Dose
integer
C0146224 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0205539 (UMLS CUI [1,4])
Topotecan; Therapeutic radiology procedure, Daily Dose, Actual
Item
Actual Daily Dose
integer
C0146224 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0237400 (UMLS CUI [1,4])
Therapeutic radiology procedure, Daily Dose
Item
RT Daily Dose
integer
C0146224 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0237400 (UMLS CUI [1,4])

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

Fields marked with * are required.

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