ID

29867

Beschreibung

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

Stichworte

Versionen (1)
  1. 24.04.18 24.04.18 - Halim Ugurlu
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GSK

Hochgeladen am

24. April 2018

DOI

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GSK Study ID 104864-201-Pre-Next Course (Course 02)

Englisch

Pre-Next Course

1 Formulare  
  1. StudyEvent: ODM
    1. Pre-Next Course
Identification Numbers
Beschreibung

Identification Numbers

Alias
UMLS CUI-1
C1300638
Center Number
Beschreibung

Center Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Serious Adverse Experiences
Beschreibung

Serious Adverse Experiences

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

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

Datentyp

boolean

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

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Date Performed
Beschreibung

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

Datentyp

date

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

Result

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0430456
Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)
Beschreibung

Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)

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

Ejection Fraction

Datentyp

boolean

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

If Yes for the obtained Ejection Fraction

Alias
UMLS CUI-1
C2700378
Date Performed
Beschreibung

Date Performed

Datentyp

date

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

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

Datentyp

float

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

Which procedure was performed?

Datentyp

text

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

Result of Echocardiography/MUGA

Datentyp

text

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

Chest X-Ray

Alias
UMLS CUI-1
C0039985
Date Performed
Beschreibung

Date Performed

Datentyp

date

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

Result of Chest X-Ray

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0039985
Supportive Therapy (Including Erythropoietin)
Beschreibung

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?
Beschreibung

Supportive Therapy (Including Erythropoietin)

Datentyp

boolean

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

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
Beschreibung

Type of transfusions

Datentyp

text

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

Transfusions (Number of Units)

Datentyp

text

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

Erythropoietin Dose

Datentyp

float

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

Date

Datentyp

date

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

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?
Beschreibung

Supportive Anti-Infective Therapy

Datentyp

boolean

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

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)
Beschreibung

Drug name

Datentyp

text

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

Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1]
C2348070
Route
Beschreibung

For Route, see general instructions for acceptable abbreviations.

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Medical Condition
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C3843040
Other
Beschreibung

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.

Datentyp

text

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

Start Date

Datentyp

date

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

End Date

Datentyp

date

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

If Continuing to Medication

Datentyp

boolean

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

Concominant Medication

Alias
UMLS CUI-1
C2347852
Concominant Medication
Beschreibung

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.

Datentyp

boolean

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

If Yes to Concominant Medication

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

Drug name

Datentyp

text

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

Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1]
C2348070
Route
Beschreibung

Route

Datentyp

text

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

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.

Datentyp

text

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

Start Date

Datentyp

date

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

End Date

Datentyp

date

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

If Continung to Medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
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Ähnliche Modelle

Pre-Next Course

1 Formulare
  1. StudyEvent: ODM
    1. Pre-Next Course
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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