ID
29870
Beschreibung
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
Stichworte
Versionen (2)
- 24.04.18 24.04.18 - Halim Ugurlu
- 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
Rechteinhaber
GSK
Hochgeladen am
24. April 2018
DOI
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Lizenz
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
Beschreibung
Post Treatment Follow-Up
Alias
- UMLS CUI-1
- C1522577
- UMLS CUI-2
- C2709088
Beschreibung
Week of Follow-Up Visit
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0589121
- UMLS CUI [1,2]
- C0439230
Beschreibung
Outcome
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1624730
- UMLS CUI [1,2]
- C0012634
Beschreibung
Date of first documented disease progression since the Topotecan study conclusion
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242656
- UMLS CUI [1,3]
- C1707478
- UMLS CUI [1,4]
- C0146224
Beschreibung
Health Care Resource Utilization
Alias
- UMLS CUI-1
- C1704738
Beschreibung
If Yes to Hospitalization
Alias
- UMLS CUI-1
- C0019993
Beschreibung
Hospitalization
Datentyp
text
Alias
- UMLS CUI [1]
- C0019993
Beschreibung
Date of Hospitalization
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0011008
Beschreibung
Reason of Hospitalization
Datentyp
text
Alias
- UMLS CUI [1]
- C1830395
Beschreibung
FACT-An
Alias
- UMLS CUI-1
- C3641634
Beschreibung
Stem Cell Transplant (SCT) Follow-Up
Alias
- UMLS CUI-1
- C1504389
- UMLS CUI-2
- C1522577
Beschreibung
Source of Stem Cells
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0449416
- UMLS CUI [1,2]
- C0038250
Beschreibung
Date of Stem Cell Transplant
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0011008
Beschreibung
Please mark the appropriate method of SCT below and record the date of transplant.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0439859
- UMLS CUI [2]
- C1515895
Beschreibung
Additional chemotherapy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C1706712
- UMLS CUI [1,3]
- C0376450
Beschreibung
If ’Yes’ please indicate chemotherapy regimen/agents below
Alias
- UMLS CUI-1
- C0392920
Beschreibung
Total body irradiation
Alias
- UMLS CUI-1
- C0043162
Beschreibung
Signature-Name of Person
Alias
- UMLS CUI-1
- C2346576
- UMLS CUI-2
- C1547383
Beschreibung
Signature of Investigator
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date of Signature
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Printed Name of Person Completing Form
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1550483
- UMLS CUI [1,2]
- C1301584
Beschreibung
Date-Printed Name of Person Completing Form
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1550483
- UMLS CUI [1,3]
- C1301584
Beschreibung
Patient Assignment Sheet
Alias
- UMLS CUI-1
- C1955348
Beschreibung
Patient Assignment Sheet
Alias
- UMLS CUI-1
- C1955348
Beschreibung
Do not enter the patient on the patient assignment sheet until he she starts open label medication.
Datentyp
text
Alias
- UMLS CUI [1]
- C2986440
Beschreibung
Patient Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C1830427
Beschreibung
Date of First Dose
Datentyp
date
Alias
- UMLS CUI [1]
- C3173309
Beschreibung
Date of Last Dose
Datentyp
date
Alias
- UMLS CUI [1]
- C1762893
Beschreibung
Status (C/W)
Datentyp
text
Alias
- UMLS CUI [1]
- C0449438
Beschreibung
Patient Log
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C2828389
Beschreibung
Patient Log
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C2828389
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C2986440
Beschreibung
Initial Interview
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Reason for Exclusion
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2828389
- UMLS CUI [1,2]
- C0008976
Beschreibung
Month of Report
Alias
- UMLS CUI-1
- C0439231
- UMLS CUI-2
- C0684224
Beschreibung
Outcome
Alias
- UMLS CUI-1
- C0085565
Beschreibung
Patient Died
Datentyp
text
Alias
- UMLS CUI [1]
- C1546956
Beschreibung
If Yes to "Patient Died", Complete FROM D below
Datentyp
date
Alias
- UMLS CUI [1]
- C0805839
Beschreibung
Lost to Follow-Up
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1302313
Beschreibung
Has the disease progressed?
Datentyp
text
Alias
- UMLS CUI [1]
- C0242656
Beschreibung
Date of first documented disease progression since the Topotecan study conclusion:
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242656
- UMLS CUI [1,3]
- C0146224
- UMLS CUI [1,4]
- C1707478
Beschreibung
Post Study Cancer Therapy
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1882428
- UMLS CUI [1,2]
- C0920425
Beschreibung
Beginning date of Post-Study cancer therapy (Chemotherapy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C3665472
Beschreibung
Beginning date of Post-Study cancer therapy (Radiotherapy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C1522449
Beschreibung
Beginning date of Post-Study cancer therapy (Immunotherapy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C0021083
Beschreibung
Beginning date of Post-Study cancer therapy (Biologic)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C0005527
Beschreibung
Beginning date of Post-Study cancer therapy (Not Specified)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C1882428
Beschreibung
From D
Alias
- UMLS CUI-1
- C0011066
Beschreibung
Cause of Death
Datentyp
text
Alias
- UMLS CUI [1]
- C0007465
Beschreibung
Date of Death
Datentyp
date
Alias
- UMLS CUI [1]
- C1148348
Beschreibung
Was an autopsy done?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beschreibung
If Yes to "Autopsy Done"
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beschreibung
I certify that I have reviewed the follow-up data and that all information is complete and accurate
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator`s Signature
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Cause of Death
Datentyp
text
Alias
- UMLS CUI [1]
- C0007465
Beschreibung
Complete Adverse Experience Form
Datentyp
date
Alias
- UMLS CUI [1]
- C1148348
Beschreibung
Was an autopsy done?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beschreibung
Physician`s Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C0807938
Beschreibung
Physician`s Signature
Datentyp
date
Alias
- UMLS CUI [1]
- C0807938
Beschreibung
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Beschreibung
Investigator
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0086715
Beschreibung
Laboratory Name
Datentyp
text
Alias
- UMLS CUI [1]
- C1882331
Beschreibung
Address
Datentyp
text
Alias
- UMLS CUI [1]
- C1442065
Beschreibung
Referance Range
Alias
- UMLS CUI-1
- C0086715
Beschreibung
Referance - Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Age Range
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0005774
- UMLS CUI [1,3]
- C0042014
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Low Reference Value
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205251
Beschreibung
High Reference Value
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205250
Ähnliche Modelle
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])