ID
42020
Beskrivning
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
Länk
https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Nyckelord
Versioner (2)
- 2018-04-24 2018-04-24 - Halim Ugurlu
- 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
Rättsinnehavare
GSK
Uppladdad den
15 mars 2021
DOI
För en begäran logga in.
Licens
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
Beskrivning
Post Treatment Follow-Up
Alias
- UMLS CUI-1
- C1522577
- UMLS CUI-2
- C2709088
Beskrivning
Week of Follow-Up Visit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0589121
- UMLS CUI [1,2]
- C0439230
Beskrivning
Outcome
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1624730
- UMLS CUI [1,2]
- C0012634
Beskrivning
Date of first documented disease progression since the Topotecan study conclusion
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242656
- UMLS CUI [1,3]
- C1707478
- UMLS CUI [1,4]
- C0146224
Beskrivning
Health Care Resource Utilization
Alias
- UMLS CUI-1
- C1704738
Beskrivning
If Yes to Hospitalization
Alias
- UMLS CUI-1
- C0019993
Beskrivning
Hospitalization
Datatyp
text
Alias
- UMLS CUI [1]
- C0019993
Beskrivning
Date of Hospitalization
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0011008
Beskrivning
Reason of Hospitalization
Datatyp
text
Alias
- UMLS CUI [1]
- C1830395
Beskrivning
FACT-An
Alias
- UMLS CUI-1
- C3641634
Beskrivning
Stem Cell Transplant (SCT) Follow-Up
Alias
- UMLS CUI-1
- C1504389
- UMLS CUI-2
- C1522577
Beskrivning
Source of Stem Cells
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0449416
- UMLS CUI [1,2]
- C0038250
Beskrivning
Date of Stem Cell Transplant
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0011008
Beskrivning
Please mark the appropriate method of SCT below and record the date of transplant.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0439859
- UMLS CUI [2]
- C1515895
Beskrivning
Additional chemotherapy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C1706712
- UMLS CUI [1,3]
- C0376450
Beskrivning
If ’Yes’ please indicate chemotherapy regimen/agents below
Alias
- UMLS CUI-1
- C0392920
Beskrivning
Total body irradiation
Alias
- UMLS CUI-1
- C0043162
Beskrivning
Signature-Name of Person
Alias
- UMLS CUI-1
- C2346576
- UMLS CUI-2
- C1547383
Beskrivning
Signature of Investigator
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Date of Signature
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Printed Name of Person Completing Form
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1550483
- UMLS CUI [1,2]
- C1301584
Beskrivning
Date-Printed Name of Person Completing Form
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1550483
- UMLS CUI [1,3]
- C1301584
Beskrivning
Patient Assignment Sheet
Alias
- UMLS CUI-1
- C1955348
Beskrivning
Patient Assignment Sheet
Alias
- UMLS CUI-1
- C1955348
Beskrivning
Do not enter the patient on the patient assignment sheet until he she starts open label medication.
Datatyp
text
Alias
- UMLS CUI [1]
- C2986440
Beskrivning
Patient Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C1830427
Beskrivning
Date of First Dose
Datatyp
date
Alias
- UMLS CUI [1]
- C3173309
Beskrivning
Date of Last Dose
Datatyp
date
Alias
- UMLS CUI [1]
- C1762893
Beskrivning
Status (C/W)
Datatyp
text
Alias
- UMLS CUI [1]
- C0449438
Beskrivning
Patient Log
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C2828389
Beskrivning
Patient Log
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C2828389
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C2986440
Beskrivning
Initial Interview
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Reason for Exclusion
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2828389
- UMLS CUI [1,2]
- C0008976
Beskrivning
Month of Report
Alias
- UMLS CUI-1
- C0439231
- UMLS CUI-2
- C0684224
Beskrivning
Outcome
Alias
- UMLS CUI-1
- C0085565
Beskrivning
Patient Died
Datatyp
text
Alias
- UMLS CUI [1]
- C1546956
Beskrivning
If Yes to "Patient Died", Complete FROM D below
Datatyp
date
Alias
- UMLS CUI [1]
- C0805839
Beskrivning
Lost to Follow-Up
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1302313
Beskrivning
Has the disease progressed?
Datatyp
text
Alias
- UMLS CUI [1]
- C0242656
Beskrivning
Date of first documented disease progression since the Topotecan study conclusion:
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242656
- UMLS CUI [1,3]
- C0146224
- UMLS CUI [1,4]
- C1707478
Beskrivning
Post Study Cancer Therapy
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1882428
- UMLS CUI [1,2]
- C0920425
Beskrivning
Beginning date of Post-Study cancer therapy (Chemotherapy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C3665472
Beskrivning
Beginning date of Post-Study cancer therapy (Radiotherapy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C1522449
Beskrivning
Beginning date of Post-Study cancer therapy (Immunotherapy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C0021083
Beskrivning
Beginning date of Post-Study cancer therapy (Biologic)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C0005527
Beskrivning
Beginning date of Post-Study cancer therapy (Not Specified)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
Beskrivning
From D
Alias
- UMLS CUI-1
- C0011066
Beskrivning
Cause of Death
Datatyp
text
Alias
- UMLS CUI [1]
- C0007465
Beskrivning
Date of Death
Datatyp
date
Alias
- UMLS CUI [1]
- C1148348
Beskrivning
Was an autopsy done?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beskrivning
If Yes to "Autopsy Done"
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beskrivning
I certify that I have reviewed the follow-up data and that all information is complete and accurate
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator`s Signature
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Cause of Death
Datatyp
text
Alias
- UMLS CUI [1]
- C0007465
Beskrivning
Complete Adverse Experience Form
Datatyp
date
Alias
- UMLS CUI [1]
- C1148348
Beskrivning
Was an autopsy done?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beskrivning
Physician`s Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C0807938
Beskrivning
Physician`s Signature
Datatyp
date
Alias
- UMLS CUI [1]
- C0807938
Beskrivning
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Beskrivning
Investigator
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0086715
Beskrivning
Laboratory Name
Datatyp
text
Alias
- UMLS CUI [1]
- C1882331
Beskrivning
Address
Datatyp
text
Alias
- UMLS CUI [1]
- C1442065
Beskrivning
Referance Range
Alias
- UMLS CUI-1
- C0086715
Beskrivning
Referance - Gender
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Age Range
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0005774
- UMLS CUI [1,3]
- C0042014
Beskrivning
Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Low Reference Value
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205251
Beskrivning
High Reference Value
Datatyp
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])