ID

29857

Description

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Link

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Keywords

Versions (1)
  1. 4/24/18 4/24/18 - Halim Ugurlu
Copyright Holder

GSK

Uploaded on

April 24, 2018

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License

Creative Commons BY-NC 3.0
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GSK Study ID 104864-201 Pre-Next Course

English

Pre-Next Course

1 forms  
  1. StudyEvent: ODM
    1. Pre-Next Course
Identification Numbers
Description

Identification Numbers

Alias
UMLS CUI-1
C1300638
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Serious Adverse Experiences
Description

Serious Adverse Experiences

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

If there have been any serious adverse experiences since the last visit, please record details in the Serious Adverse Experience section.

Data type

boolean

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

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Date Performed
Description

Date Performed

Data type

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
Result of 12-Lead ECG
Description

Result

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0430456
Is this not done?
Description

Perform only if clinically indicated, or if this is the patient's last course.

Data type

boolean

Alias
UMLS CUI [1]
C1623258
Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)
Description

Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)

Alias
UMLS CUI-1
C0013516
UMLS CUI-3
C0521317
Was an Ejection Fraction obtained?
Description

Ejection Fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
If Yes for the obtained Ejection Fraction
Description

If Yes for the obtained Ejection Fraction

Alias
UMLS CUI-1
C2700378
Date Performed
Description

Date Performed

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013516
UMLS CUI [2]
C0521317
LV Ejection Fraction (2-dimensional mode) (%)
Description

LV Ejection Fraction (2-dimensional mode) (%)

Data type

float

Alias
UMLS CUI [1]
C0428772
Which procedure was performed?
Description

Which procedure was performed?

Data type

text

Alias
UMLS CUI [1]
C0013516
UMLS CUI [2]
C0521317
Result of Echocardiography/MUGA
Description

Result of Echocardiography/MUGA

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0013516
UMLS CUI [2]
C0521317
Chest X-Ray
Description

Chest X-Ray

Alias
UMLS CUI-1
C0039985
Date Performed
Description

Date Performed

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0039985
Result of Chest X-Ray
Description

Result of Chest X-Ray

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0039985
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Similar models

Pre-Next Course

1 forms
  1. StudyEvent: ODM
    1. Pre-Next Course
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Identification Numbers
C1300638 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Serious Adverse Experiences
C1519255 (UMLS CUI-1)
Serious adverse experiences
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)
Date Performed
Item
Date Performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of 12-Lead ECG
text
C1274040 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Result
Code List
Result of 12-Lead ECG
CL Item
Normal/no clinically significant abnormality (1)
CL Item
Clinically significant abnormality (If 'Yes' please record details on the Significant Medical/ Surgical History and Physical Examination page.) (2)
Perform Status
Item
Is this not done?
boolean
C1623258 (UMLS CUI [1])
Item Group
Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)
C0013516 (UMLS CUI-1)
C0521317 (UMLS CUI-3)
Ejection Fraction
Item
Was an Ejection Fraction obtained?
boolean
C0232174 (UMLS CUI [1])
Item Group
If Yes for the obtained Ejection Fraction
C2700378 (UMLS CUI-1)
Date Performed
Item
Date Performed
date
C0011008 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
LV Ejection Fraction (2-dimensional mode) (%)
Item
LV Ejection Fraction (2-dimensional mode) (%)
float
C0428772 (UMLS CUI [1])
Item
Which procedure was performed?
text
C0013516 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
Which procedure was performed?
Code List
Which procedure was performed?
CL Item
Echocardiogram (1)
CL Item
MUGA (2)
Item
Result of Echocardiography/MUGA
text
C1274040 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
Result of Echocardiography/MUGA
Code List
Result of Echocardiography/MUGA
CL Item
No significant worsening since screening (1)
CL Item
Worsening since screening (Please record in the Adverse Experience section) (2)
Item Group
Chest X-Ray
C0039985 (UMLS CUI-1)
Date Performed
Item
Date Performed
date
C0011008 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
Item
Result of Chest X-Ray
text
C1274040 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
Result of Chest X-Ray
Code List
Result of Chest X-Ray
CL Item
No significant worsening since screenin (1)
CL Item
Worsening since screening (Please record in the Adverse Experience section) (2)
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