ID
42020
Description
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
Keywords
Versions (2)
- 4/24/18 4/24/18 - Halim Ugurlu
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder
GSK
Uploaded on
March 15, 2021
DOI
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License
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
Description
Post Treatment Follow-Up
Alias
- UMLS CUI-1
- C1522577
- UMLS CUI-2
- C2709088
Description
Week of Follow-Up Visit
Data type
text
Alias
- UMLS CUI [1,1]
- C0589121
- UMLS CUI [1,2]
- C0439230
Description
Outcome
Data type
text
Alias
- UMLS CUI [1,1]
- C1624730
- UMLS CUI [1,2]
- C0012634
Description
Date of first documented disease progression since the Topotecan study conclusion
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242656
- UMLS CUI [1,3]
- C1707478
- UMLS CUI [1,4]
- C0146224
Description
Health Care Resource Utilization
Alias
- UMLS CUI-1
- C1704738
Description
If Yes to Hospitalization
Alias
- UMLS CUI-1
- C0019993
Description
Hospitalization
Data type
text
Alias
- UMLS CUI [1]
- C0019993
Description
Date of Hospitalization
Data type
date
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0011008
Description
Reason of Hospitalization
Data type
text
Alias
- UMLS CUI [1]
- C1830395
Description
FACT-An
Alias
- UMLS CUI-1
- C3641634
Description
Stem Cell Transplant (SCT) Follow-Up
Alias
- UMLS CUI-1
- C1504389
- UMLS CUI-2
- C1522577
Description
Source of Stem Cells
Data type
text
Alias
- UMLS CUI [1,1]
- C0449416
- UMLS CUI [1,2]
- C0038250
Description
Date of Stem Cell Transplant
Data type
date
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0011008
Description
Please mark the appropriate method of SCT below and record the date of transplant.
Data type
text
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0439859
- UMLS CUI [2]
- C1515895
Description
Additional chemotherapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C1706712
- UMLS CUI [1,3]
- C0376450
Description
If ’Yes’ please indicate chemotherapy regimen/agents below
Alias
- UMLS CUI-1
- C0392920
Description
Total body irradiation
Alias
- UMLS CUI-1
- C0043162
Description
Signature-Name of Person
Alias
- UMLS CUI-1
- C2346576
- UMLS CUI-2
- C1547383
Description
Signature of Investigator
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date of Signature
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Printed Name of Person Completing Form
Data type
text
Alias
- UMLS CUI [1,1]
- C1550483
- UMLS CUI [1,2]
- C1301584
Description
Date-Printed Name of Person Completing Form
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1550483
- UMLS CUI [1,3]
- C1301584
Description
Patient Assignment Sheet
Alias
- UMLS CUI-1
- C1955348
Description
Patient Assignment Sheet
Alias
- UMLS CUI-1
- C1955348
Description
Do not enter the patient on the patient assignment sheet until he she starts open label medication.
Data type
text
Alias
- UMLS CUI [1]
- C2986440
Description
Patient Number
Data type
integer
Alias
- UMLS CUI [1]
- C1830427
Description
Date of First Dose
Data type
date
Alias
- UMLS CUI [1]
- C3173309
Description
Date of Last Dose
Data type
date
Alias
- UMLS CUI [1]
- C1762893
Description
Status (C/W)
Data type
text
Alias
- UMLS CUI [1]
- C0449438
Description
Patient Log
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C2828389
Description
Patient Log
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C2828389
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C2986440
Description
Initial Interview
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Reason for Exclusion
Data type
text
Alias
- UMLS CUI [1,1]
- C2828389
- UMLS CUI [1,2]
- C0008976
Description
Month of Report
Alias
- UMLS CUI-1
- C0439231
- UMLS CUI-2
- C0684224
Description
Outcome
Alias
- UMLS CUI-1
- C0085565
Description
Patient Died
Data type
text
Alias
- UMLS CUI [1]
- C1546956
Description
If Yes to "Patient Died", Complete FROM D below
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
Lost to Follow-Up
Data type
boolean
Alias
- UMLS CUI [1]
- C1302313
Description
Has the disease progressed?
Data type
text
Alias
- UMLS CUI [1]
- C0242656
Description
Date of first documented disease progression since the Topotecan study conclusion:
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242656
- UMLS CUI [1,3]
- C0146224
- UMLS CUI [1,4]
- C1707478
Description
Post Study Cancer Therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C1882428
- UMLS CUI [1,2]
- C0920425
Description
Beginning date of Post-Study cancer therapy (Chemotherapy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C3665472
Description
Beginning date of Post-Study cancer therapy (Radiotherapy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C1522449
Description
Beginning date of Post-Study cancer therapy (Immunotherapy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C0021083
Description
Beginning date of Post-Study cancer therapy (Biologic)
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C0005527
Description
Beginning date of Post-Study cancer therapy (Not Specified)
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
Description
From D
Alias
- UMLS CUI-1
- C0011066
Description
Cause of Death
Data type
text
Alias
- UMLS CUI [1]
- C0007465
Description
Date of Death
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Was an autopsy done?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Description
If Yes to "Autopsy Done"
Data type
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Description
I certify that I have reviewed the follow-up data and that all information is complete and accurate
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator`s Signature
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Cause of Death
Data type
text
Alias
- UMLS CUI [1]
- C0007465
Description
Complete Adverse Experience Form
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Was an autopsy done?
Data type
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Description
Physician`s Signature
Data type
text
Alias
- UMLS CUI [1]
- C0807938
Description
Physician`s Signature
Data type
date
Alias
- UMLS CUI [1]
- C0807938
Description
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Description
Investigator
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0086715
Description
Laboratory Name
Data type
text
Alias
- UMLS CUI [1]
- C1882331
Description
Address
Data type
text
Alias
- UMLS CUI [1]
- C1442065
Description
Referance Range
Alias
- UMLS CUI-1
- C0086715
Description
Referance - Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Age Range
Data type
text
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0005774
- UMLS CUI [1,3]
- C0042014
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Low Reference Value
Data type
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205251
Description
High Reference Value
Data type
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])