ID

29854

Descripción

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

Palabras clave

Versiones (1)
  1. 24/4/18 24/4/18 - Halim Ugurlu
Titular de derechos de autor

GSK

Subido en

24 de abril de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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GSK Study ID 104864-201

Inglés

Screening

1 formularios  
  1. StudyEvent: ODM
    1. Screening
Identification Numbers
Descripción

Identification Numbers

Alias
UMLS CUI-1
C1300638
Center Number
Descripción

Center Number

Tipo de datos

text

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

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Demography
Descripción

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Descripción

Date of Birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Race

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Height (cm)
Descripción

Height (cm)

Tipo de datos

float

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0489786
cm
Height (inch)
Descripción

Height (inch)

Tipo de datos

float

Unidades de medida
  • inch
Alias
UMLS CUI [1]
C0489786
inch
Temperature localization
Descripción

Temperature

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0475264
Temperature Grad
Descripción

Temperature

Tipo de datos

float

Alias
UMLS CUI [1]
C0039476
Temperature C/F
Descripción

Temperature

Tipo de datos

text

Alias
UMLS CUI [1]
C0039476
Sitting Blood Pressure, Systolic-mmHg, After 5 Minutes Sitting
Descripción

Sitting Blood Pressure

Tipo de datos

integer

Alias
UMLS CUI [1]
C0580946
Sitting Blood Pressure, Diastolic-mmHg, After 5 Minutes Sitting
Descripción

Sitting Blood Pressure, Diastolic-mmHg, After 5 Minutes Sitting

Tipo de datos

integer

Alias
UMLS CUI [1]
C0580946
Pulse (beats/min), After 5 Minutes Sitting
Descripción

Pulse

Tipo de datos

integer

Alias
UMLS CUI [1]
C0232117
12-Lead Electrocardiogram
Descripción

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Date Performed
Descripción

Date Performed

Tipo de datos

date

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

Result

Tipo de datos

text

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

Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)

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

Ejection Fraction

Tipo de datos

boolean

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

If Yes for the obtained Ejection Fraction

Alias
UMLS CUI-1
C2700378
Date Performed
Descripción

Date Performed

Tipo de datos

date

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

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

Tipo de datos

float

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

Which procedure was performed?

Tipo de datos

text

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

Result of Echocardiography/MUGA

Tipo de datos

text

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

Chest X-Ray

Alias
UMLS CUI-1
C0039985
Date Performed
Descripción

Date Performed

Tipo de datos

date

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

Result of Chest X-Ray

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0039985
History of Myelodysplastic Syndrome / Acute Myelogenous Leukemia
Descripción

History of Myelodysplastic Syndrome / Acute Myelogenous Leukemia

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0085669
UMLS CUI-3
C3463824
Date of firts diagnosis of MDS
Descripción

Date of firts diagnosis of MDS

Tipo de datos

date

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C2316983
Date of diagnosis of AML (if applicable)
Descripción

Date of diagnosis of AML

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0023467
Variant (choose only one)
Descripción

Variant

Tipo de datos

text

Alias
UMLS CUI [1]
C0205419
Previous Chemotherapy for MDS or AML
Descripción

Previous Chemotherapy for MDS or AML

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0023467
UMLS CUI-3
C3463824
Has the patient had any chemotherapy for MDS or AML?
Descripción

Previous Chemotherapy for MDS or AML

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023467
UMLS CUI [1,3]
C3463824
If Yes to Previous Chemotherapy for MDS or AML
Descripción

If Yes to Previous Chemotherapy for MDS or AML

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0023467
UMLS CUI-3
C3463824
First Line Regimen
Descripción

First Line Regimen

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0750480
Please specify the Regimen Number for each component of the regimen.
Descripción

Regimen Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0237753
Cumulative Dose (units)
Descripción

Cumulative Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C2986497
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0040808
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0040808
Best Response Code
Descripción

Best Response Code

Tipo de datos

text

Alias
UMLS CUI [1]
C2986560
If not PD, provide duration of response (weeks)
Descripción

If not PD, provide duration of response (weeks)

Tipo de datos

text

Alias
UMLS CUI [1]
C0237585
Previous Biologic Therapy and/or Immunotherapy for MDS or AML
Descripción

Previous Biologic Therapy and/or Immunotherapy for MDS or AML

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0005527
UMLS CUI-3
C0278947
UMLS CUI-4
C0023467
Has the patient had any biologic therapy and/or immunotherapy for MDS or AML?
Descripción

Previous Biologic Therapy and/or Immunotherapy for MDS or AML

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0005527
UMLS CUI [1,3]
C0278947
UMLS CUI [1,4]
C0023467
If Yes to Previous Biologic Therapy and/or Immunotherapy for MDS or AML
Descripción

If Yes to Previous Biologic Therapy and/or Immunotherapy for MDS or AML

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0005527
UMLS CUI-3
C0278947
UMLS CUI-4
C0023467
Regimen
Descripción

Regimen

Tipo de datos

text

Alias
UMLS CUI [1]
C0237125
Therapy No
Descripción

Therapy No

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750480
Cumulative Dose (units)
Descripción

Cumulative Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C2986497
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0040808
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0040808
Best Response Code
Descripción

Best Response Code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2986560
UMLS CUI [1,2]
C0805701
If not PD, provide duration of response (weeks)
Descripción

If not PD, provide duration of response (weeks)

Tipo de datos

text

Alias
UMLS CUI [1]
C0237585
Toxicities Related to Previous Therapy for MDS or AML
Descripción

Toxicities Related to Previous Therapy for MDS or AML

Alias
UMLS CUI-1
C0023467
UMLS CUI-2
C3463824
UMLS CUI-3
C2114510
UMLS CUI-4
C0439849
UMLS CUI-5
C0600688
Does the patient have any other residual toxicities related to previous therapy for MDS or AML?
Descripción

Toxicities Related to Previous Therapy for MDS or AML

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C3463824
UMLS CUI [1,3]
C2114510
UMLS CUI [1,4]
C0439849
UMLS CUI [1,5]
C0600688
If Yes to Toxicities Related to Previous Therapy for MDS or AML
Descripción

If Yes to Toxicities Related to Previous Therapy for MDS or AML

Alias
UMLS CUI-1
C0023467
UMLS CUI-2
C3463824
UMLS CUI-3
C2114510
UMLS CUI-4
C0439849
UMLS CUI-5
C0600688
Toxicity
Descripción

Toxicity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C2114510
UMLS CUI [1,3]
C0439849
NCI Toxicity Grade
Descripción

NCI Common Toxicity Grade

Tipo de datos

text

Alias
UMLS CUI [1]
C2826262
Previous Therapy
Descripción

Previous Therapy

Tipo de datos

text

Alias
UMLS CUI [1]
C2114510
Prior Transfusion Therapy (Including Erythropoietin)
Descripción

Prior Transfusion Therapy (Including Erythropoietin)

Alias
UMLS CUI-1
C1879316
UMLS CUI-2
C1514463
UMLS CUI-3
C0014822
Has the patient received any transfusion during the 4 weeks prior to this study?
Descripción

Record the medical condition in the Ongoing Medical Conditions Associated with MDS or AML section

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0014822
If Yes to Prior Transfusion Therapy (Including Erythropoietin)
Descripción

If Yes to Prior Transfusion Therapy (Including Erythropoietin)

Alias
UMLS CUI-1
C1879316
UMLS CUI-2
C1514463
UMLS CUI-3
C0014822
Specify the type of transfusions
Descripción

Type of transfusions

Tipo de datos

text

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

Transfusions (Number of Units)

Tipo de datos

text

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

Erythropoietin Dose

Tipo de datos

float

Unidades de medida
  • units/kg
Alias
UMLS CUI [1,1]
C0014822
UMLS CUI [1,2]
C3174092
units/kg
Date of transfusion
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1879316
Prior Anti-Infective Therapy
Descripción

Prior Anti-Infective Therapy

Alias
UMLS CUI-1
C1141958
UMLS CUI-2
C1514463
Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) during the 4 weeks prior to entering this study?
Descripción

Prior Anti-Infective Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1141958
UMLS CUI [1,2]
C1514463
If Yes to Prior Anti-Infective Therapy
Descripción

If Yes to Prior Anti-Infective Therapy

Alias
UMLS CUI-1
C1141958
UMLS CUI-2
C1514463
Drug name (Trade Name Preferred)
Descripción

Drug name

Tipo de datos

text

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

Total Daily Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C2348070
Route
Descripción

For Route, see general instructions for acceptable abbreviations.

Tipo de datos

text

Alias
UMLS CUI [1]
C0013153
Medical Condition
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C3843040
Other
Descripción

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.

Tipo de datos

text

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

Start Date

Tipo de datos

date

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

End Date

Tipo de datos

date

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

If Continuing to Medication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Prior and Concominant Medication
Descripción

Prior and Concominant Medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Has the patient taken any medication in the past 30 days?
Descripción

Prior and Concominant Medication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2347852
If Yes to Prior and Concominant Medication
Descripción

If Yes to Prior and Concominant Medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Drug name (Trade name Preferred)
Descripción

Drug name

Tipo de datos

text

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

Total Daily Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C2348070
Route
Descripción

Route

Tipo de datos

text

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

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.

Tipo de datos

text

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

Start Date

Tipo de datos

date

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

End Date

Tipo de datos

date

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

If Continung to Medication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Ongoing Medical Conditions Associated with MDS or AML
Descripción

Ongoing Medical Conditions Associated with MDS or AML

Alias
UMLS CUI-1
C0205476
UMLS CUI-2
C0348080
UMLS CUI-3
C0549178
UMLS CUI-4
C0023467
UMLS CUI-5
C3463824
Does the Patient have any ongoing medical condition(s) that is associated with their MDS or AML?
Descripción

Ongoing Medical Conditions Associated with MDS or AML

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0023467
UMLS CUI [1,5]
C3463824
If Yes to Ongoing Medical Conditions Associated with MDS or AML
Descripción

If Yes to Ongoing Medical Conditions Associated with MDS or AML

Alias
UMLS CUI-1
C0205476
UMLS CUI-2
C0348080
UMLS CUI-3
C0549178
UMLS CUI-4
C0023467
UMLS CUI-5
C3463824
Condition
Descripción

Condition

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0023467
UMLS CUI [1,5]
C3463824
NCI Toxicity Grade
Descripción

NCI Common Toxicity Grade

Tipo de datos

text

Alias
UMLS CUI [1]
C2826262
Date of first diagnosis
Descripción

Date of first diagnosis

Tipo de datos

date

Alias
UMLS CUI [1]
C2316983
Prior Malignancies
Descripción

Prior Malignancies

Alias
UMLS CUI-1
C0006826
UMLS CUI-2
C0332132
Has the patient had any prior malignancies for which he/she has received prior treatment?
Descripción

Prior Malignancies

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332132
If Yes to Prior Malignancies
Descripción

If Yes to Prior Malignancies

Alias
UMLS CUI-1
C0006826
UMLS CUI-2
C0332132
Prior Malignancy
Descripción

Prior Malignancy

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332132
Prior Therapy
Descripción

Prior Therapy

Tipo de datos

text

Alias
UMLS CUI [1]
C1514463
Date of Diagnosis
Descripción

Date of Diagnosis

Tipo de datos

date

Alias
UMLS CUI [1]
C2316983
Date of Complete Remission
Descripción

Date of Complete Remission

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0677874
Significant Medical/Surgery History and Physical Examination
Descripción

Significant Medical/Surgery History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
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)?
Descripción

Significant Medical/Surgery History and Physical Examination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0031809
If Yes to Significant Medical/Surgery History and Physical Examination
Descripción

If Yes to Significant Medical/Surgery History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Diagnosis
Descripción

If 'Yes' please provide diagnosis below, listing no more than one diagnosis per line. All signs and symptoms referring to a single diagnosis must be recorded on the same line with the diagnosis. Signs and symptoms with out an associated diagnosis must be recorded on separate lines.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0031809
NCI Grade
Descripción

NCI Grade

Tipo de datos

text

Alias
UMLS CUI [1]
C3887242
Year of Firts Diagnosis
Descripción

Year of Firts Diagnosis

Tipo de datos

partialDate

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Past
Descripción

Past

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C0262926
Current/Active
Descripción

Current/Active

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2707252
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Screening

1 formularios
  1. StudyEvent: ODM
    1. Screening
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (C)
CL Item
Black (B)
CL Item
Oriental (E)
CL Item
Other, specify:............ (O)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Height (cm)
Item
Height (cm)
float
C0489786 (UMLS CUI [1])
Height (inch)
Item
Height (inch)
float
C0489786 (UMLS CUI [1])
Item
Temperature localization
text
C0039476 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
Temperature
Code List
Temperature localization
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])
Item
Temperature C/F
text
C0039476 (UMLS CUI [1])
Temperature
Code List
Temperature C/F
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])
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)
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) (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])
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
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
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
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)
Date of firts diagnosis of MDS
Item
Date of firts diagnosis of MDS
date
C3463824 (UMLS CUI [1,1])
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])
Item
Variant (choose only one)
text
C0205419 (UMLS CUI [1])
Variant
Code List
Variant (choose only one)
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)
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])
Item Group
If Yes to Previous Chemotherapy for MDS or AML
C1514463 (UMLS CUI-1)
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])
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])
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])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
Item
Best Response Code
text
C2986560 (UMLS CUI [1])
Best Response Code
Code List
Best Response Code
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)
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])
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)
Regimen
Item
Regimen
text
C0237125 (UMLS CUI [1])
Item
Therapy No
text
C0087111 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Therapy No
Code List
Therapy No
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])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
Item
Best Response Code
text
C2986560 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Best Response Code
Code List
Best Response Code
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)
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])
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)
Toxicity
Item
Toxicity
text
C0600688 (UMLS CUI [1,1])
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)
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])
Item Group
If Yes to Prior Transfusion Therapy (Including Erythropoietin)
C1879316 (UMLS CUI-1)
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])
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
Prior Anti-Infective Therapy
C1141958 (UMLS CUI-1)
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])
Item Group
If Yes to Prior Anti-Infective Therapy
C1141958 (UMLS CUI-1)
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])
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
Prior and Concominant Medication
C2826257 (UMLS CUI-1)
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])
Item Group
If Yes to Prior and Concominant Medication
C2826257 (UMLS CUI-1)
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])
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])
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)
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])
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)
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])
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])
Item Group
Prior Malignancies
C0006826 (UMLS CUI-1)
C0332132 (UMLS CUI-2)
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])
Item Group
If Yes to Prior Malignancies
C0006826 (UMLS CUI-1)
C0332132 (UMLS CUI-2)
Prior Malignancy
Item
Prior Malignancy
text
C0006826 (UMLS CUI [1,1])
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])
Item Group
Significant Medical/Surgery History and Physical Examination
C0262926 (UMLS CUI-1)
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])
Item Group
If Yes to Significant Medical/Surgery History and Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Diagnosis
Item
Diagnosis
text
C0262926 (UMLS CUI [1,1])
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])
Past
Item
Past
boolean
C1444637 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Current/Active
Item
Current/Active
boolean
C2707252 (UMLS CUI [1])
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