ID
42020
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 https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Link
https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Palabras clave
Versiones (2)
- 24/4/18 24/4/18 - Halim Ugurlu
- 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
Titular de derechos de autor
GSK
Subido en
15 de marzo de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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GSK Study ID 104864-201 Post-Treatment Follow-Up
Post Treatment Follow-Up
- StudyEvent: ODM
Descripción
Post Treatment Follow-Up
Alias
- UMLS CUI-1
- C1522577
- UMLS CUI-2
- C2709088
Descripción
Week of Follow-Up Visit
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0589121
- UMLS CUI [1,2]
- C0439230
Descripción
Outcome
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1624730
- UMLS CUI [1,2]
- C0012634
Descripción
Date of first documented disease progression since the Topotecan study conclusion
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242656
- UMLS CUI [1,3]
- C1707478
- UMLS CUI [1,4]
- C0146224
Descripción
Health Care Resource Utilization
Alias
- UMLS CUI-1
- C1704738
Descripción
If Yes to Hospitalization
Alias
- UMLS CUI-1
- C0019993
Descripción
Hospitalization
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0019993
Descripción
Date of Hospitalization
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0011008
Descripción
Reason of Hospitalization
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1830395
Descripción
FACT-An
Alias
- UMLS CUI-1
- C3641634
Descripción
Stem Cell Transplant (SCT) Follow-Up
Alias
- UMLS CUI-1
- C1504389
- UMLS CUI-2
- C1522577
Descripción
Source of Stem Cells
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0449416
- UMLS CUI [1,2]
- C0038250
Descripción
Date of Stem Cell Transplant
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0011008
Descripción
Please mark the appropriate method of SCT below and record the date of transplant.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0439859
- UMLS CUI [2]
- C1515895
Descripción
Additional chemotherapy
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C1706712
- UMLS CUI [1,3]
- C0376450
Descripción
If ’Yes’ please indicate chemotherapy regimen/agents below
Alias
- UMLS CUI-1
- C0392920
Descripción
Total body irradiation
Alias
- UMLS CUI-1
- C0043162
Descripción
Signature-Name of Person
Alias
- UMLS CUI-1
- C2346576
- UMLS CUI-2
- C1547383
Descripción
Signature of Investigator
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Date of Signature
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Printed Name of Person Completing Form
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1550483
- UMLS CUI [1,2]
- C1301584
Descripción
Date-Printed Name of Person Completing Form
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1550483
- UMLS CUI [1,3]
- C1301584
Descripción
Patient Assignment Sheet
Alias
- UMLS CUI-1
- C1955348
Descripción
Patient Assignment Sheet
Alias
- UMLS CUI-1
- C1955348
Descripción
Do not enter the patient on the patient assignment sheet until he she starts open label medication.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2986440
Descripción
Patient Number
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1830427
Descripción
Date of First Dose
Tipo de datos
date
Alias
- UMLS CUI [1]
- C3173309
Descripción
Date of Last Dose
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1762893
Descripción
Status (C/W)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0449438
Descripción
Patient Log
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C2828389
Descripción
Patient Log
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C2828389
Descripción
Enter ALL Patients who have been considered for the study and who have been interviewed. For patients not entering the trial, note the reason for exclusion in the designated column.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2986440
Descripción
Initial Interview
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
Reason for Exclusion
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2828389
- UMLS CUI [1,2]
- C0008976
Descripción
Month of Report
Alias
- UMLS CUI-1
- C0439231
- UMLS CUI-2
- C0684224
Descripción
Outcome
Alias
- UMLS CUI-1
- C0085565
Descripción
Patient Died
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1546956
Descripción
If Yes to "Patient Died", Complete FROM D below
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0805839
Descripción
Lost to Follow-Up
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1302313
Descripción
Has the disease progressed?
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0242656
Descripción
Date of first documented disease progression since the Topotecan study conclusion:
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242656
- UMLS CUI [1,3]
- C0146224
- UMLS CUI [1,4]
- C1707478
Descripción
Post Study Cancer Therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1882428
- UMLS CUI [1,2]
- C0920425
Descripción
Beginning date of Post-Study cancer therapy (Chemotherapy)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C3665472
Descripción
Beginning date of Post-Study cancer therapy (Radiotherapy)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C1522449
Descripción
Beginning date of Post-Study cancer therapy (Immunotherapy)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C0021083
Descripción
Beginning date of Post-Study cancer therapy (Biologic)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C0005527
Descripción
Beginning date of Post-Study cancer therapy (Not Specified)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
Descripción
From D
Alias
- UMLS CUI-1
- C0011066
Descripción
Cause of Death
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0007465
Descripción
Date of Death
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
Was an autopsy done?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Descripción
If Yes to "Autopsy Done"
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Descripción
I certify that I have reviewed the follow-up data and that all information is complete and accurate
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator`s Signature
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Cause of Death
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0007465
Descripción
Complete Adverse Experience Form
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
Was an autopsy done?
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Descripción
Physician`s Signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0807938
Descripción
Physician`s Signature
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0807938
Descripción
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Descripción
Investigator
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0086715
Descripción
Laboratory Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1882331
Descripción
Address
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1442065
Descripción
Referance Range
Alias
- UMLS CUI-1
- C0086715
Descripción
Referance - Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Age Range
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Descripción
Enter the referance range for each test. If the reference ranges for any test differ by sex or age, complete a separate form for each variation, e.g., males 0-16, males 17-99, females 0-16, females 17-99 years. Complete the units reported by this laboratory for each test.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0005774
- UMLS CUI [1,3]
- C0042014
Descripción
Unit
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519795
Descripción
Low Reference Value
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205251
Descripción
High Reference Value
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205250
Similar models
Post Treatment Follow-Up
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C2709088 (UMLS CUI-2)
C0439230 (UMLS CUI [1,2])
C0242656 (UMLS CUI [1,2])
C1707478 (UMLS CUI [1,3])
C0146224 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0038250 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0439859 (UMLS CUI [1,2])
C1515895 (UMLS CUI [2])
C1706712 (UMLS CUI [1,2])
C0376450 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,2])
C1547383 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,2])
C1550483 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
C0242656 (UMLS CUI [1,2])
C0146224 (UMLS CUI [1,3])
C1707478 (UMLS CUI [1,4])
C0920425 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,2])
C1882428 (UMLS CUI [1,3])
C3665472 (UMLS CUI [1,4])
C0920425 (UMLS CUI [1,2])
C1882428 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
C0920425 (UMLS CUI [1,2])
C1882428 (UMLS CUI [1,3])
C0021083 (UMLS CUI [1,4])
C0920425 (UMLS CUI [1,2])
C1882428 (UMLS CUI [1,3])
C0005527 (UMLS CUI [1,4])
C0920425 (UMLS CUI [1,2])
C1882428 (UMLS CUI [1,3])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,2])
C1514721 (UMLS CUI [1,2])
C0005774 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C1522609 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C1522609 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])