ID

29867

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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Creative Commons BY-NC 3.0
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GSK Study ID 104864-201-Pre-Next Course (Course 02)

English

Pre-Next Course

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

Identification Numbers

Alias
UMLS CUI-1
C1300638
Center Number
Description

Center Number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
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
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
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

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

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
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
Supportive Therapy (Including Erythropoietin)
Description

Supportive Therapy (Including Erythropoietin)

Alias
UMLS CUI-1
C1879316
UMLS CUI-2
C0014822
UMLS CUI-3
C0344211
UMLS CUI-4
C1707479
Has the patient received any transfusions during this course?
Description

Supportive Therapy (Including Erythropoietin)

Data type

boolean

Alias
UMLS CUI [1,1]
C0344211
UMLS CUI [1,2]
C1707479
If Yes to Supportive Therapy (Including Erythropoietin)
Description

If Yes to Supportive Therapy (Including Erythropoietin)

Alias
UMLS CUI-1
C1879316
UMLS CUI-2
C0014822
UMLS CUI-3
C0344211
UMLS CUI-4
C1707479
Specify the type of transfusions
Description

Type of transfusions

Data type

text

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C0332307
Transfusions (Number of Units)
Description

Transfusions (Number of Units)

Data type

text

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C0237753
Erythropoietin Dose
Description

Erythropoietin Dose

Data type

float

Measurement units
  • units/kg
Alias
UMLS CUI [1,1]
C0014822
UMLS CUI [1,2]
C3174092
units/kg
Date of transfusion
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1879316
Supportive Anti-Infective Therapy
Description

Supportive Anti-Infective Therapy

Alias
UMLS CUI-1
C1141958
UMLS CUI-2
C0344211
UMLS CUI-3
C1707479
Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) during this course?
Description

Supportive Anti-Infective Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1141958
UMLS CUI [1,2]
C0344211
UMLS CUI [1,3]
C1707479
If Yes to Supportive Anti-Infective Therapy
Description

If Yes to Supportive Anti-Infective Therapy

Alias
UMLS CUI-1
C1141958
UMLS CUI-2
C0344211
UMLS CUI-3
C1707479
Drug name (Trade Name Preferred)
Description

Drug name

Data type

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose (e.g. 500mg)
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Route
Description

For Route, see general instructions for acceptable abbreviations.

Data type

text

Alias
UMLS CUI [1]
C0013153
Medical Condition
Description

Where appropriate, medical conditions should be recorded in the Ongoing Medical Conditions Associated with MDS or AML section, utilizing the same terminology.

Data type

text

Alias
UMLS CUI [1]
C3843040
Other
Description

Record PM for anti-infectives administered prophylactically, EM for anti-infectives used for symptomatic treatment, and TX for anti-infectives administered for a confirmed infection in the column provided.

Data type

text

Alias
UMLS CUI [1]
C1141958
Start Date (be as precise as possible)
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C3174092
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C3174092
If Continuing to Medication
Description

If Continuing to Medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Concominant Medication
Description

Concominant Medication

Alias
UMLS CUI-1
C2347852
Concominant Medication
Description

Record all concomitant medication taken during this course. Record PM for prophylactic treatment with Medical Condition for prophylactically administered medications. If a medication was marked 'Continuing' at the initial visit, it must be recorded below. Where appropriate, medical conditions should be recorded on the Adverse Experience Form, utilizing the same terminology.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
If Yes to Concominant Medication
Description

If Yes to Concominant Medication

Alias
UMLS CUI-1
C2347852
Drug name (Trade name Preferred)
Description

Drug name

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C2347852
Total Daily Dose (e.g. 500mg)
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Route
Description

Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C2347852
Medical Condition
Description

Where appropriate, medical conditions should be recorded in the Significant Medical/Surgical History and Physical Examination section, utilizing the same terminology. Prior chemotherapy, biological, and immunotherapy should be recorded on pages 4 and 5. Record PM for prophylactic treatment with the Medical Condition for prophylactically administered medications.

Data type

text

Alias
UMLS CUI [1]
C3843040
Start Date (be as precise as possible)
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C2347852
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C2347852
If Continung to Medication
Description

If Continung to Medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
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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)
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Serious Adverse Experiences
C1519255 (UMLS CUI-1)
Serious Adverse Experience
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
No significant worsening since screening (2)
CL Item
Worsening since screening -> Please record in the Adverse Experience section (3)
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 (2)
CL Item
Worsening since screening -> Please record in the Adverse Experience section (3)
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 screening (2)
CL Item
Worsening since screening -> Please record in the Adverse Experience section (3)
Item Group
Supportive Therapy (Including Erythropoietin)
C1879316 (UMLS CUI-1)
C0014822 (UMLS CUI-2)
C0344211 (UMLS CUI-3)
C1707479 (UMLS CUI-4)
Supportive Therapy (Including Erythropoietin)
Item
Has the patient received any transfusions during this course?
boolean
C0344211 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
Item Group
If Yes to Supportive Therapy (Including Erythropoietin)
C1879316 (UMLS CUI-1)
C0014822 (UMLS CUI-2)
C0344211 (UMLS CUI-3)
C1707479 (UMLS CUI-4)
Type of transfusions
Item
Specify the type of transfusions
text
C1879316 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Transfusions (Number of Units)
Item
Transfusions (Number of Units)
text
C1879316 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Erythropoietin Dose
Item
Erythropoietin Dose
float
C0014822 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Date
Item
Date of transfusion
date
C0011008 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
Item Group
Supportive Anti-Infective Therapy
C1141958 (UMLS CUI-1)
C0344211 (UMLS CUI-2)
C1707479 (UMLS CUI-3)
Supportive Anti-Infective Therapy
Item
Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) during this course?
boolean
C1141958 (UMLS CUI [1,1])
C0344211 (UMLS CUI [1,2])
C1707479 (UMLS CUI [1,3])
Item Group
If Yes to Supportive Anti-Infective Therapy
C1141958 (UMLS CUI-1)
C0344211 (UMLS CUI-2)
C1707479 (UMLS CUI-3)
Drug name
Item
Drug name (Trade Name Preferred)
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose (e.g. 500mg)
text
C2348070 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Medical Condition
Item
Medical Condition
text
C3843040 (UMLS CUI [1])
Item
Other
text
C1141958 (UMLS CUI [1])
Other
Code List
Other
CL Item
anti-infectives administered prophylactically (PM)
CL Item
anti-infectives used for symptomatic treatment (EM)
CL Item
anti-infectives administered for a confirmed infection in the column provided (TX)
Start Date
Item
Start Date (be as precise as possible)
date
C0808070 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
If Continuing to Medication
Item
If Continuing to Medication
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Concominant Medication
C2347852 (UMLS CUI-1)
Concominant Medication
Item
boolean
C2347852 (UMLS CUI [1])
Item Group
If Yes to Concominant Medication
C2347852 (UMLS CUI-1)
Drug name
Item
Drug name (Trade name Preferred)
text
C2360065 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Total Daily Dose
Item
Total Daily Dose (e.g. 500mg)
text
C2348070 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Medical Condition
Item
Medical Condition
text
C3843040 (UMLS CUI [1])
Start Date
Item
Start Date (be as precise as possible)
date
C0808070 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
If Continung to Medication
Item
If Continung to Medication
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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