ID

37689

Descripción

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

Palabras clave

  1. 16/8/19 16/8/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de agosto de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0

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

Study Medication

  1. StudyEvent: ODM
    1. Study Medication
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Center number
Descripción

Study Coordinating Center, Identification number

Tipo de datos

integer

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

Patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Descripción

Person Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Descripción

Date of visit

Tipo de datos

date

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

Weight/Body Surface Area

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

Body Weight, Unit of Measure

Tipo de datos

text

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

Body Weight

Tipo de datos

float

Body Surface Area
Descripción

Body Surface Area

Tipo de datos

float

Unidades de medida
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Topotecan Study Medication/Radiation Record
Descripción

Topotecan Study Medication/Radiation Record

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

Topotecan, Therapeutic radiology procedure, Day

Tipo de datos

text

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

Topotecan; Therapeutic radiology procedure, Date in time

Tipo de datos

date

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

Topotecan; Therapeutic radiology procedure, Daily Dose, Scheduled

Tipo de datos

integer

Unidades de medida
  • 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
Descripción

Topotecan; Therapeutic radiology procedure, Daily Dose, Actual

Tipo de datos

integer

Unidades de medida
  • 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
Descripción

Therapeutic radiology procedure, Daily Dose

Tipo de datos

integer

Unidades de medida
  • 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
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])

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