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

Trial screening

Topotecan

AML

D009190

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

model
Detalles

Screening

1 formularios

StudyEvent: ODM
1. Screening

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Identification Numbers

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])

Demography

Item Group

Demography

C0011298 (UMLS CUI-1)

Date of Birth

Item

Date of Birth

date

C0421451 (UMLS CUI [1])

Gender

Item

Gender

text

C0079399 (UMLS CUI [1])

Gender

Code List

Gender

CL Item

Male (M)

CL Item

Female (F)

Race

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)

Vital Signs

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])

Temperature

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])

Temperature

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])

12-Lead Electrocardiogram

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])

Result

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)

Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)

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])

If Yes for the obtained Ejection Fraction

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])

Which procedure was performed?

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)

Result of Echocardiography/MUGA

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)

Chest X-Ray

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])

Result of Chest X-Ray

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)

History of Myelodysplastic Syndrome / Acute Myelogenous Leukemia

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])

Variant

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)

Previous Chemotherapy for MDS or AML

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])

If Yes to Previous Chemotherapy for MDS or AML

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])

Best Response Code

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])

Previous Biologic Therapy and/or Immunotherapy for MDS or AML

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])

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

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])

Therapy No

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])

Best Response Code

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])

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

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])

Prior Transfusion Therapy (Including Erythropoietin)

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])

If Yes to Prior Transfusion Therapy (Including Erythropoietin)

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])

Prior Anti-Infective Therapy

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])

If Yes to Prior Anti-Infective Therapy

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])

Other

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])

Prior and Concominant Medication

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])

If Yes to Prior and Concominant Medication

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])

Ongoing Medical Conditions Associated with MDS or AML

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])

If Yes to Ongoing Medical Conditions Associated with MDS or AML

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])

Prior Malignancies

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])

If Yes to Prior Malignancies

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])

Significant Medical/Surgery History and Physical Examination

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])

If Yes to Significant Medical/Surgery History and Physical Examination

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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ID

Descripción

Palabras clave

Versiones (1)

Titular de derechos de autor

Subido en

DOI

Licencia

Comentarios del modelo :

Comentarios de grupo de elementos para :

Comentarios del elemento para :

GSK Study ID 104864-201

Screening

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Unidades de medida

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