Informatie:
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ID
42020
Beschrijving
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
Trefwoorden
Versies (2)
- 24-04-18 24-04-18 - Halim Ugurlu
- 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
Houder van rechten
GSK
Geüploaded op
15 maart 2021
DOI
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Licentie
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
Similar models
Post Treatment Follow-Up
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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])
Hospital Number
Item
Hospital Number (if needed)
text
C0806432 (UMLS CUI [1])
Item Group
Post Treatment Follow-Up
C1522577 (UMLS CUI-1)
C2709088 (UMLS CUI-2)
C2709088 (UMLS CUI-2)
Item
Week of Follow-Up Visit - Please mark the appropriate box to indicate week of this follow-up visit:
text
C0589121 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,2])
Code List
Week of Follow-Up Visit - Please mark the appropriate box to indicate week of this follow-up visit:
CL Item
2 weeks (1)
(Comment:en)
CL Item
4 weeks (2)
(Comment:en)
CL Item
6 weeks (3)
(Comment:en)
CL Item
8 weeks (4)
(Comment:en)
CL Item
10 weeks (5)
(Comment:en)
CL Item
12 weeks (6)
(Comment:en)
CL Item
Other, specify......... (7)
(Comment:en)
CL Item
No (1)
CL Item
Yes (2)
CL Item
N/A (if patient progressed on study) (3)
Date of first documented disease progression since the Topotecan study conclusion
Item
Date of first documented disease progression since the Topotecan study conclusion
date
C0011008 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C1707478 (UMLS CUI [1,3])
C0146224 (UMLS CUI [1,4])
C0242656 (UMLS CUI [1,2])
C1707478 (UMLS CUI [1,3])
C0146224 (UMLS CUI [1,4])
Hospitalization
Item
Did the patient require any hospitalization(s) since the last visit?
boolean
C0019993 (UMLS CUI [1])
CL Item
Admission (1)
CL Item
Discharge (2)
Date of Hospitalization
Item
Date of Hospitalization
date
C0019993 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Reason of Hospitalization
Item
Specify the reason on the line provided
text
C1830395 (UMLS CUI [1])
FACT-An
Item
FACT-An
text
C3641634 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
Item Group
Stem Cell Transplant (SCT) Follow-Up
C1504389 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C1522577 (UMLS CUI-2)
Item
Source of Stem Cells:
text
C0449416 (UMLS CUI [1,1])
C0038250 (UMLS CUI [1,2])
C0038250 (UMLS CUI [1,2])
CL Item
Peripheral Blood (1)
CL Item
Bone Marrow (2)
Date of Stem Cell Transplant
Item
Date of Stem Cell Transplant
date
C1504389 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Method of Stem Cell Transplant
text
C1504389 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C1515895 (UMLS CUI [2])
C0439859 (UMLS CUI [1,2])
C1515895 (UMLS CUI [2])
CL Item
Autologous (1)
CL Item
Allogeneic (2)
Additional chemotherapy
Item
Has Patient received additional chemotherapy after completing study treatment as pre-conditioning regimen for SCT?
boolean
C0392920 (UMLS CUI [1,1])
C1706712 (UMLS CUI [1,2])
C0376450 (UMLS CUI [1,3])
C1706712 (UMLS CUI [1,2])
C0376450 (UMLS CUI [1,3])
Item Group
If ’Yes’ please indicate chemotherapy regimen/agents below
C0392920 (UMLS CUI-1)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Date Treatment Started
Item
Date Treatment Started
date
C3173309 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
Total body irradiation
Item
Has the patient had total body irradiation (TBI)?
boolean
C0043162 (UMLS CUI [1])
Item Group
Signature-Name of Person
C2346576 (UMLS CUI-1)
C1547383 (UMLS CUI-2)
C1547383 (UMLS CUI-2)
Signature of Investigator
Item
Signature of Investigator
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Printed Name of Person Completing Form
Item
Printed Name of Person Completing Form
text
C1550483 (UMLS CUI [1,1])
C1301584 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,2])
Date-Printed Name of Person Completing Form
Item
Date-Printed Name of Person Completing Form
date
C0011008 (UMLS CUI [1,1])
C1550483 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,3])
C1550483 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,3])
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Date of First Dose
Item
Date of First Dose
date
C3173309 (UMLS CUI [1])
Date of Last Dose
Item
Date of Last Dose
date
C1762893 (UMLS CUI [1])
CL Item
Completed treatment and follow-up phases (C)
CL Item
Withdrawn prior to completing treatment and follow-up phases (W)
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Initial Interview
Item
Initial Interview
date
C0011008 (UMLS CUI [1])
Reason for Exclusion
Item
Reason for Exclusion
text
C2828389 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
Month of Report
Item
Month of Report
integer
C0439231 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
If No to "Patient Died", Date of last patient contact (i.e., visit, telephone)
Item
If No to "Patient Died", Date of last patient contact (i.e., visit, telephone)
date
C0805839 (UMLS CUI [1])
Lost to Follow-Up
Item
Was the patient lost to follow-up?
boolean
C1302313 (UMLS CUI [1])
CL Item
No (1)
CL Item
Yes (2)
CL Item
N/A (if patient progressed on study) (3)
Date of first documented disease progression since the Topotecan study conclusion:
Item
Date of first documented disease progression since the Topotecan study conclusion:
date
C0011008 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0146224 (UMLS CUI [1,3])
C1707478 (UMLS CUI [1,4])
C0242656 (UMLS CUI [1,2])
C0146224 (UMLS CUI [1,3])
C1707478 (UMLS CUI [1,4])
Item
Please mark box to indicate any post study cancer therapy received
text
C1882428 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,2])
Code List
Please mark box to indicate any post study cancer therapy received
CL Item
none (1)
CL Item
Chemotherapy (2)
CL Item
Radiotherapy (3)
CL Item
Immunotherapy (6)
CL Item
Biologic (9)
CL Item
Not Specified (7)
Beginning date of Post-Study cancer therapy (Chemotherapy)
Item
Beginning date of Post-Study cancer therapy (Chemotherapy)
date
C0808070 (UMLS CUI [1,1])
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])
C3665472 (UMLS CUI [1,4])
Beginning date of Post-Study cancer therapy (Radiotherapy)
Item
Beginning date of Post-Study cancer therapy (Radiotherapy)
date
C0808070 (UMLS CUI [1,1])
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])
C1522449 (UMLS CUI [1,4])
Beginning date of Post-Study cancer therapy (Immunotherapy)
Item
Beginning date of Post-Study cancer therapy (Immunotherapy)
date
C0808070 (UMLS CUI [1,1])
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])
C0021083 (UMLS CUI [1,4])
Beginning date of Post-Study cancer therapy (Biologic)
Item
Beginning date of Post-Study cancer therapy (Biologic)
date
C0808070 (UMLS CUI [1,1])
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])
C0005527 (UMLS CUI [1,4])
Beginning date of Post-Study cancer therapy (Not Specified)
Item
Beginning date of Post-Study cancer therapy (Not Specified)
date
C0808070 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1882428 (UMLS CUI [1,3])
C0920425 (UMLS CUI [1,2])
C1882428 (UMLS CUI [1,3])
CL Item
Progressive Disease (P)
CL Item
Other:Specify.................................. (O)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Was an autopsy done?
Item
Was an autopsy done?
boolean
C0004398 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
If Yes to "Autopsy Done"
Item
If "Yes" please summarize findings (include diagnosis)
text
C0004398 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
Investigator`s Signature
Item
Investigator`s Signature
text
C2346576 (UMLS CUI [1])
Investigator`s Signature
Item
Investigator`s Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Progressive Disease (P)
CL Item
Toxicity: Hematologic (Complete Adverse Experience Form) (H)
CL Item
Toxicity: Non-Hematologic (Complete Adverse Experience Form) (N)
CL Item
Other, specify (Complete Adverse Experience Form) : (O)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Item
Was an autopsy done?
text
C0004398 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Yes (Please summarize findings, include diagnosis) (2)
Physician`s Signature
Item
Physician`s Signature
text
C0807938 (UMLS CUI [1])
Physician`s Signature
Item
Physician`s Signature
date
C0807938 (UMLS CUI [1])
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Date
Item
Date for which these reference ranges became effective
date
C0808070 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,2])
Laboratory Name
Item
Laboratory Name
text
C1882331 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
Age Range
Item
Age Range
text
C0001779 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C1514721 (UMLS CUI [1,2])
Item
Hematology (1-15), Blood Chemistry (16-34), Urinanalysis (35-41)
text
C0474523 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C0005774 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
CL Item
Hemoglobin (1)
CL Item
Hematocrit (2)
CL Item
RBC (3)
CL Item
WBC (4)
CL Item
Neutrophils-segmented (5)
CL Item
Bands (6)
CL Item
Lymphocytes (7)
CL Item
Monocytes (8)
CL Item
Eosinophils (9)
CL Item
Basophils (10)
CL Item
Platelets (11)
CL Item
Blast Cells (12)
CL Item
Prothrombin Time (PT) (13)
CL Item
Partial Thromboplastin Time(PTT) (14)
CL Item
Fibrinogen (15)
CL Item
Sodium (16)
CL Item
Potassium (17)
CL Item
Chloride (18)
CL Item
Bicharbonate (19)
CL Item
Calcium (20)
CL Item
Phosphorus (21)
CL Item
Magnesium (22)
CL Item
BUN (23)
CL Item
Urea (24)
CL Item
Uric Asid (25)
CL Item
Creatinine (26)
CL Item
Alkaline Phosphatase (27)
CL Item
LDH (28)
CL Item
SGOT/ASAT (29)
CL Item
SGPT/ALAT (30)
CL Item
Total Bilirubin (31)
CL Item
Direct Bilirubin (32)
CL Item
Total Protein (33)
CL Item
Albumin (34)
CL Item
Protein (35)
CL Item
Glucose (36)
CL Item
Blood (37)
CL Item
RBC/HPF (38)
CL Item
WBC/HPF (39)
CL Item
Casts/LPF (40)
CL Item
Crystals/LPF (41)
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Low Reference Value
Item
Low Reference Value
text
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C1522609 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
High Reference Value
Item
High Reference Value
text
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
C1522609 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
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