ID

37702

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. 8/19/19 8/19/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 19, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

English

Post RT/Prior to Surgery

1 forms  
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
Serious Adverse Experience
Description

Serious Adverse Experience

Alias
UMLS CUI-1
C1519255
Has the patient had any serious adverse experiences during this course?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
12-Lead Electrocardiogram
Description

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Required only if clinically indicated. Mark the box if not required.
Description

12 lead ECG, Requirement

Data type

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1514873
Date Performed
Description

12 lead ECG, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Result
Description

12 lead ECG, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Study Medication Compliance
Description

Study Medication Compliance

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Number of Capsules Dispensed - 1.0 mg
Description

Experimental drug, Topotecan, Capsules, Amount Dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C0805077
Number of Capsules Dispensed - 0.25 mg
Description

Experimental drug, Topotecan, Capsules, Amount Dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C0805077
Number of Capsules Taken - 1.0 mg
Description

Experimental drug, Topotecan, Capsules, Taken

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C1883727
Number of Capsules Taken - 0.25 mg
Description

Experimental drug, Topotecan, Capsules, Taken

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C1883727
Number of Capsules Returned - 1.0 mg
Description

Experimental drug, Topotecan, Capsules, Amount Returned

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C2699071
Number of Capsules Returned - 0.25 mg
Description

Experimental drug, Topotecan, Capsules, Amount Returned

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C2699071
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Similar models

Post RT/Prior to Surgery

1 forms
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
Serious Adverse Experience
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Has the patient had any serious adverse experiences during this course?
boolean
C1519255 (UMLS CUI [1])
Item Group
12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
12 lead ECG, Requirement
Item
Required only if clinically indicated. Mark the box if not required.
boolean
C0430456 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
12 lead ECG, Date in time
Item
Date Performed
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
text
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Result
CL Item
No significant worsening since screening (1)
CL Item
Worsening since screening (2)
Item Group
Study Medication Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Experimental drug, Topotecan, Capsules, Amount Dispensed
Item
Number of Capsules Dispensed - 1.0 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C0805077 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsules, Amount Dispensed
Item
Number of Capsules Dispensed - 0.25 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C0805077 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsules, Taken
Item
Number of Capsules Taken - 1.0 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsules, Taken
Item
Number of Capsules Taken - 0.25 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsules, Amount Returned
Item
Number of Capsules Returned - 1.0 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C2699071 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsules, Amount Returned
Item
Number of Capsules Returned - 0.25 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C2699071 (UMLS CUI [1,4])
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