Informações:
Falhas:
ID
29854
Descrição
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
Palavras-chave
Versões (1)
- 24/04/2018 24/04/2018 - Halim Ugurlu
Titular dos direitos
GSK
Transferido a
24 de abril de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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GSK Study ID 104864-201
Similar models
Screening
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
White (C)
CL Item
Black (B)
CL Item
Oriental (E)
CL Item
Other, specify:............ (O)
Height (cm)
Item
Height (cm)
float
C0489786 (UMLS CUI [1])
Height (inch)
Item
Height (inch)
float
C0489786 (UMLS CUI [1])
CL Item
Oral (O)
CL Item
Axillary (A)
CL Item
Rectal (R)
CL Item
Tympanic (T)
Temperature
Item
Temperature Grad
float
C0039476 (UMLS CUI [1])
CL Item
Celcius (C)
CL Item
Fahrenheit (F)
Sitting Blood Pressure
Item
Sitting Blood Pressure, Systolic-mmHg, After 5 Minutes Sitting
integer
C0580946 (UMLS CUI [1])
Sitting Blood Pressure, Diastolic-mmHg, After 5 Minutes Sitting
Item
Sitting Blood Pressure, Diastolic-mmHg, After 5 Minutes Sitting
integer
C0580946 (UMLS CUI [1])
Pulse
Item
Pulse (beats/min), After 5 Minutes Sitting
integer
C0232117 (UMLS CUI [1])
Date Performed
Item
Date Performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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)
Item Group
Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)
C0013516 (UMLS CUI-1)
C0521317 (UMLS CUI-3)
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])
C0013516 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
LV Ejection Fraction (2-dimensional mode) (procent)
Item
LV Ejection Fraction (2-dimensional mode) (procent)
float
C0428772 (UMLS CUI [1])
Item
Which procedure was performed?
text
C0013516 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C0521317 (UMLS CUI [2])
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])
C0013516 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
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)
Date Performed
Item
Date Performed
date
C0011008 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,2])
Item
Result of Chest X-Ray
text
C1274040 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,2])
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)
Item Group
History of Myelodysplastic Syndrome / Acute Myelogenous Leukemia
C0262926 (UMLS CUI-1)
C0085669 (UMLS CUI-2)
C3463824 (UMLS CUI-3)
C0085669 (UMLS CUI-2)
C3463824 (UMLS CUI-3)
Date of firts diagnosis of MDS
Item
Date of firts diagnosis of MDS
date
C3463824 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
Date of diagnosis of AML
Item
Date of diagnosis of AML (if applicable)
date
C2316983 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,2])
CL Item
INT-2 RAEB (1)
CL Item
High Risk RAEB (2)
CL Item
RAEB-t (3)
CL Item
AML (4)
Item Group
Previous Chemotherapy for MDS or AML
C1514463 (UMLS CUI-1)
C0023467 (UMLS CUI-2)
C3463824 (UMLS CUI-3)
C0023467 (UMLS CUI-2)
C3463824 (UMLS CUI-3)
Previous Chemotherapy for MDS or AML
Item
Has the patient had any chemotherapy for MDS or AML?
boolean
C1514463 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C3463824 (UMLS CUI [1,3])
C0023467 (UMLS CUI [1,2])
C3463824 (UMLS CUI [1,3])
Item Group
If Yes to Previous Chemotherapy for MDS or AML
C1514463 (UMLS CUI-1)
C0023467 (UMLS CUI-2)
C3463824 (UMLS CUI-3)
C0023467 (UMLS CUI-2)
C3463824 (UMLS CUI-3)
First Line Regimen
Item
First Line Regimen
text
C0040808 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
Regimen Number
Item
Please specify the Regimen Number for each component of the regimen.
text
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Cumulative Dose
Item
Cumulative Dose (units)
text
C2986497 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,2])
CL Item
Complete response (CR) (1)
CL Item
Partial response (PR) (2)
CL Item
Stable Disease (SD) (3)
CL Item
Progression (PD) (4)
CL Item
Hematologic Improvement (HI) (15)
If not PD, provide duration of response (weeks)
Item
If not PD, provide duration of response (weeks)
text
C0237585 (UMLS CUI [1])
Item Group
Previous Biologic Therapy and/or Immunotherapy for MDS or AML
C1514463 (UMLS CUI-1)
C0005527 (UMLS CUI-2)
C0278947 (UMLS CUI-3)
C0023467 (UMLS CUI-4)
C0005527 (UMLS CUI-2)
C0278947 (UMLS CUI-3)
C0023467 (UMLS CUI-4)
Previous Biologic Therapy and/or Immunotherapy for MDS or AML
Item
Has the patient had any biologic therapy and/or immunotherapy for MDS or AML?
boolean
C1514463 (UMLS CUI [1,1])
C0005527 (UMLS CUI [1,2])
C0278947 (UMLS CUI [1,3])
C0023467 (UMLS CUI [1,4])
C0005527 (UMLS CUI [1,2])
C0278947 (UMLS CUI [1,3])
C0023467 (UMLS CUI [1,4])
Item Group
If Yes to Previous Biologic Therapy and/or Immunotherapy for MDS or AML
C1514463 (UMLS CUI-1)
C0005527 (UMLS CUI-2)
C0278947 (UMLS CUI-3)
C0023467 (UMLS CUI-4)
C0005527 (UMLS CUI-2)
C0278947 (UMLS CUI-3)
C0023467 (UMLS CUI-4)
Regimen
Item
Regimen
text
C0237125 (UMLS CUI [1])
CL Item
Biologic (1)
CL Item
Immunotherapy (3)
Cumulative Dose
Item
Cumulative Dose (units)
text
C2986497 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,2])
CL Item
Complete response (CR) (1)
CL Item
Partial response (PR) (2)
CL Item
Stable Disease (SD) (3)
CL Item
Progression (PD) (4)
CL Item
Hematologic Improvement (HI) (15)
If not PD, provide duration of response (weeks)
Item
If not PD, provide duration of response (weeks)
text
C0237585 (UMLS CUI [1])
Item Group
Toxicities Related to Previous Therapy for MDS or AML
C0023467 (UMLS CUI-1)
C3463824 (UMLS CUI-2)
C2114510 (UMLS CUI-3)
C0439849 (UMLS CUI-4)
C0600688 (UMLS CUI-5)
C3463824 (UMLS CUI-2)
C2114510 (UMLS CUI-3)
C0439849 (UMLS CUI-4)
C0600688 (UMLS CUI-5)
Toxicities Related to Previous Therapy for MDS or AML
Item
Does the patient have any other residual toxicities related to previous therapy for MDS or AML?
boolean
C0023467 (UMLS CUI [1,1])
C3463824 (UMLS CUI [1,2])
C2114510 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C0600688 (UMLS CUI [1,5])
C3463824 (UMLS CUI [1,2])
C2114510 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C0600688 (UMLS CUI [1,5])
Item Group
If Yes to Toxicities Related to Previous Therapy for MDS or AML
C0023467 (UMLS CUI-1)
C3463824 (UMLS CUI-2)
C2114510 (UMLS CUI-3)
C0439849 (UMLS CUI-4)
C0600688 (UMLS CUI-5)
C3463824 (UMLS CUI-2)
C2114510 (UMLS CUI-3)
C0439849 (UMLS CUI-4)
C0600688 (UMLS CUI-5)
Toxicity
Item
Toxicity
text
C0600688 (UMLS CUI [1,1])
C2114510 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C2114510 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
NCI Toxicity Grade
Item
NCI Toxicity Grade
text
C2826262 (UMLS CUI [1])
Previous Therapy
Item
Previous Therapy
text
C2114510 (UMLS CUI [1])
Item Group
Prior Transfusion Therapy (Including Erythropoietin)
C1879316 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C0014822 (UMLS CUI-3)
C1514463 (UMLS CUI-2)
C0014822 (UMLS CUI-3)
Prior Transfusion Therapy (Including Erythropoietin)
Item
Has the patient received any transfusion during the 4 weeks prior to this study?
boolean
C1879316 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0014822 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0014822 (UMLS CUI [1,3])
Item Group
If Yes to Prior Transfusion Therapy (Including Erythropoietin)
C1879316 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C0014822 (UMLS CUI-3)
C1514463 (UMLS CUI-2)
C0014822 (UMLS CUI-3)
Type of transfusions
Item
Specify the type of transfusions
text
C1879316 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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])
C0237753 (UMLS CUI [1,2])
Erythropoietin Dose
Item
Erythropoietin Dose
float
C0014822 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
Date
Item
Date of transfusion
date
C0011008 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,2])
Item Group
Prior Anti-Infective Therapy
C1141958 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C1514463 (UMLS CUI-2)
Prior Anti-Infective Therapy
Item
Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) during the 4 weeks prior to entering this study?
boolean
C1141958 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,2])
Item Group
If Yes to Prior Anti-Infective Therapy
C1141958 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C1514463 (UMLS CUI-2)
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])
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])
C3174092 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
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])
C0549178 (UMLS CUI [1,2])
Item Group
Prior and Concominant Medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Prior and Concominant Medication
Item
Has the patient taken any medication in the past 30 days?
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Item Group
If Yes to Prior and Concominant Medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Drug name
Item
Drug name (Trade name Preferred)
text
C2360065 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
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])
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])
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])
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])
C0549178 (UMLS CUI [1,2])
Item Group
Ongoing Medical Conditions Associated with MDS or AML
C0205476 (UMLS CUI-1)
C0348080 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
C0023467 (UMLS CUI-4)
C3463824 (UMLS CUI-5)
C0348080 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
C0023467 (UMLS CUI-4)
C3463824 (UMLS CUI-5)
Ongoing Medical Conditions Associated with MDS or AML
Item
Does the Patient have any ongoing medical condition(s) that is associated with their MDS or AML?
boolean
C0205476 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0023467 (UMLS CUI [1,4])
C3463824 (UMLS CUI [1,5])
C0348080 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0023467 (UMLS CUI [1,4])
C3463824 (UMLS CUI [1,5])
Item Group
If Yes to Ongoing Medical Conditions Associated with MDS or AML
C0205476 (UMLS CUI-1)
C0348080 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
C0023467 (UMLS CUI-4)
C3463824 (UMLS CUI-5)
C0348080 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
C0023467 (UMLS CUI-4)
C3463824 (UMLS CUI-5)
Condition
Item
Condition
text
C0205476 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0023467 (UMLS CUI [1,4])
C3463824 (UMLS CUI [1,5])
C0348080 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0023467 (UMLS CUI [1,4])
C3463824 (UMLS CUI [1,5])
NCI Common Toxicity Grade
Item
NCI Toxicity Grade
text
C2826262 (UMLS CUI [1])
Date of first diagnosis
Item
Date of first diagnosis
date
C2316983 (UMLS CUI [1])
Prior Malignancies
Item
Has the patient had any prior malignancies for which he/she has received prior treatment?
boolean
C0006826 (UMLS CUI [1,1])
C0332132 (UMLS CUI [1,2])
C0332132 (UMLS CUI [1,2])
Item Group
If Yes to Prior Malignancies
C0006826 (UMLS CUI-1)
C0332132 (UMLS CUI-2)
C0332132 (UMLS CUI-2)
Prior Malignancy
Item
Prior Malignancy
text
C0006826 (UMLS CUI [1,1])
C0332132 (UMLS CUI [1,2])
C0332132 (UMLS CUI [1,2])
Prior Therapy
Item
Prior Therapy
text
C1514463 (UMLS CUI [1])
Date of Diagnosis
Item
Date of Diagnosis
date
C2316983 (UMLS CUI [1])
Date of Complete Remission
Item
Date of Complete Remission
date
C0011008 (UMLS CUI [1,1])
C0677874 (UMLS CUI [1,2])
C0677874 (UMLS CUI [1,2])
Item Group
Significant Medical/Surgery History and Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
Significant Medical/Surgery History and Physical Examination
Item
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition (do not include ongoing conditions associated with MDS or AML or toxicities due to prior therapy for MDS or AML; exclude prior malignancies)?
boolean
C0262926 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
Item Group
If Yes to Significant Medical/Surgery History and Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
Diagnosis
Item
Diagnosis
text
C0262926 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
NCI Grade
Item
NCI Grade
text
C3887242 (UMLS CUI [1])
Year of Firts Diagnosis
Item
Year of Firts Diagnosis
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Past
Item
Past
boolean
C1444637 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Current/Active
Item
Current/Active
boolean
C2707252 (UMLS CUI [1])
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