ID

42020

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)
  1. 24.04.18 24.04.18 - Halim Ugurlu
  2. 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
Rechteinhaber

GSK

Hochgeladen am

15. März 2021

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

Englisch

Post Treatment Follow-Up

1 Formulare  
Identification Numbers
Beschreibung

Identification Numbers

Alias
UMLS CUI-1
C1300638
Center Number
Beschreibung

Center Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Hospital Number (if needed)
Beschreibung

Hospital Number

Datentyp

text

Alias
UMLS CUI [1]
C0806432
Post Treatment Follow-Up
Beschreibung

Post Treatment Follow-Up

Alias
UMLS CUI-1
C1522577
UMLS CUI-2
C2709088
Week of Follow-Up Visit - Please mark the appropriate box to indicate week of this follow-up visit:
Beschreibung

Week of Follow-Up Visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C0439230
Has disease progressed?
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C0012634
Date of first documented disease progression since the Topotecan study conclusion
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
Health Care Resource Utilization
Beschreibung

Health Care Resource Utilization

Alias
UMLS CUI-1
C1704738
Did the patient require any hospitalization(s) since the last visit?
Beschreibung

Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0019993
If Yes to Hospitalization
Beschreibung

If Yes to Hospitalization

Alias
UMLS CUI-1
C0019993
Hospitalization
Beschreibung

Hospitalization

Datentyp

text

Alias
UMLS CUI [1]
C0019993
Date of Hospitalization
Beschreibung

Date of Hospitalization

Datentyp

date

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0011008
Specify the reason on the line provided
Beschreibung

Reason of Hospitalization

Datentyp

text

Alias
UMLS CUI [1]
C1830395
FACT-An
Beschreibung

FACT-An

Alias
UMLS CUI-1
C3641634
FACT-An
Beschreibung

FACT-An

Datentyp

text

Alias
UMLS CUI [1,1]
C3641634
UMLS CUI [1,2]
C0449820
Stem Cell Transplant (SCT) Follow-Up
Beschreibung

Stem Cell Transplant (SCT) Follow-Up

Alias
UMLS CUI-1
C1504389
UMLS CUI-2
C1522577
Source of Stem Cells:
Beschreibung

Source of Stem Cells

Datentyp

text

Alias
UMLS CUI [1,1]
C0449416
UMLS CUI [1,2]
C0038250
Date of Stem Cell Transplant
Beschreibung

Date of Stem Cell Transplant

Datentyp

date

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C0011008
Method of Stem Cell Transplant
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
Has Patient received additional chemotherapy after completing study treatment as pre-conditioning regimen for SCT?
Beschreibung

Additional chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1706712
UMLS CUI [1,3]
C0376450
If ’Yes’ please indicate chemotherapy regimen/agents below
Beschreibung

If ’Yes’ please indicate chemotherapy regimen/agents below

Alias
UMLS CUI-1
C0392920
Drug name
Beschreibung

Drug name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Date Treatment Started
Beschreibung

Date Treatment Started

Datentyp

date

Alias
UMLS CUI [1,1]
C3173309
UMLS CUI [1,2]
C0392920
Total body irradiation
Beschreibung

Total body irradiation

Alias
UMLS CUI-1
C0043162
Has the patient had total body irradiation (TBI)?
Beschreibung

Total body irradiation

Datentyp

boolean

Alias
UMLS CUI [1]
C0043162
Signature-Name of Person
Beschreibung

Signature-Name of Person

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C1547383
Signature of Investigator
Beschreibung

Signature of Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Beschreibung

Date of Signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Name of Person Completing Form
Beschreibung

Printed Name of Person Completing Form

Datentyp

text

Alias
UMLS CUI [1,1]
C1550483
UMLS CUI [1,2]
C1301584
Date-Printed Name of Person Completing Form
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
Patient Assignment Sheet
Beschreibung

Patient Assignment Sheet

Alias
UMLS CUI-1
C1955348
Investigator
Beschreibung

Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Patient Assignment Sheet
Beschreibung

Patient Assignment Sheet

Alias
UMLS CUI-1
C1955348
Patient Initials
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
Patient Number
Beschreibung

Patient Number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Date of First Dose
Beschreibung

Date of First Dose

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Date of Last Dose
Beschreibung

Date of Last Dose

Datentyp

date

Alias
UMLS CUI [1]
C1762893
Status (C/W)
Beschreibung

Status (C/W)

Datentyp

text

Alias
UMLS CUI [1]
C0449438
Patient Log
Beschreibung

Patient Log

Alias
UMLS CUI-1
C0030705
UMLS CUI-2
C2828389
Investigator
Beschreibung

Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Patient Log
Beschreibung

Patient Log

Alias
UMLS CUI-1
C0030705
UMLS CUI-2
C2828389
Patient Initials
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
Initial Interview
Beschreibung

Initial Interview

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Reason for Exclusion
Beschreibung

Reason for Exclusion

Datentyp

text

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0008976
Month of Report
Beschreibung

Month of Report

Alias
UMLS CUI-1
C0439231
UMLS CUI-2
C0684224
Month of Report
Beschreibung

following completion of study treatment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439231
UMLS CUI [1,2]
C0684224
Outcome
Beschreibung

Outcome

Alias
UMLS CUI-1
C0085565
Has the patient died?
Beschreibung

Patient Died

Datentyp

text

Alias
UMLS CUI [1]
C1546956
If No to "Patient Died", Date of last patient contact (i.e., visit, telephone)
Beschreibung

If Yes to "Patient Died", Complete FROM D below

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Was the patient lost to follow-up?
Beschreibung

Lost to Follow-Up

Datentyp

boolean

Alias
UMLS CUI [1]
C1302313
Has the disease progressed?
Beschreibung

Has the disease progressed?

Datentyp

text

Alias
UMLS CUI [1]
C0242656
Date of first documented disease progression since the Topotecan study conclusion:
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
Please mark box to indicate any post study cancer therapy received
Beschreibung

Post Study Cancer Therapy

Datentyp

text

Alias
UMLS CUI [1,1]
C1882428
UMLS CUI [1,2]
C0920425
Beginning date of Post-Study cancer therapy (Chemotherapy)
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
Beginning date of Post-Study cancer therapy (Radiotherapy)
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
Beginning date of Post-Study cancer therapy (Immunotherapy)
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
Beginning date of Post-Study cancer therapy (Biologic)
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
Beginning date of Post-Study cancer therapy (Not Specified)
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
From D
Beschreibung

From D

Alias
UMLS CUI-1
C0011066
Cause of Death
Beschreibung

Cause of Death

Datentyp

text

Alias
UMLS CUI [1]
C0007465
Date of Death
Beschreibung

Date of Death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Was an autopsy done?
Beschreibung

Was an autopsy done?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0884358
If "Yes" please summarize findings (include diagnosis)
Beschreibung

If Yes to "Autopsy Done"

Datentyp

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0884358
Investigator`s Signature
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
Investigator`s Signature
Beschreibung

Investigator`s Signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Cause of Death
Beschreibung

Cause of Death

Datentyp

text

Alias
UMLS CUI [1]
C0007465
Date of Death
Beschreibung

Complete Adverse Experience Form

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Was an autopsy done?
Beschreibung

Was an autopsy done?

Datentyp

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0884358
Physician`s Signature
Beschreibung

Physician`s Signature

Datentyp

text

Alias
UMLS CUI [1]
C0807938
Physician`s Signature
Beschreibung

Physician`s Signature

Datentyp

date

Alias
UMLS CUI [1]
C0807938
Laboratory Reference Ranges
Beschreibung

Laboratory Reference Ranges

Alias
UMLS CUI-1
C0883335
Investigator
Beschreibung

Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date for which these reference ranges became effective
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0086715
Laboratory Name
Beschreibung

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C1882331
Address
Beschreibung

Address

Datentyp

text

Alias
UMLS CUI [1]
C1442065
Referance Range
Beschreibung

Referance Range

Alias
UMLS CUI-1
C0086715
Referance - Gender
Beschreibung

Referance - Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Age Range
Beschreibung

Age Range

Datentyp

text

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1514721
Hematology (1-15), Blood Chemistry (16-34), Urinanalysis (35-41)
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
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Low Reference Value
Beschreibung

Low Reference Value

Datentyp

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C1522609
UMLS CUI [1,3]
C0205251
High Reference Value
Beschreibung

High Reference Value

Datentyp

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C1522609
UMLS CUI [1,3]
C0205250
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Ähnliche Modelle

Post Treatment Follow-Up

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Identification Numbers
C1300638 (UMLS CUI-1)
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
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)
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])
Week of Follow-Up Visit
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)
Item
Has disease progressed?
text
C1624730 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Outcome
Code List
Has disease progressed?
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])
Item Group
Health Care Resource Utilization
C1704738 (UMLS CUI-1)
Hospitalization
Item
Did the patient require any hospitalization(s) since the last visit?
boolean
C0019993 (UMLS CUI [1])
Item Group
If Yes to Hospitalization
C0019993 (UMLS CUI-1)
Item
Hospitalization
text
C0019993 (UMLS CUI [1])
Hospitalization
Code List
Hospitalization
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])
Reason of Hospitalization
Item
Specify the reason on the line provided
text
C1830395 (UMLS CUI [1])
Item Group
FACT-An
C3641634 (UMLS CUI-1)
FACT-An
Item
FACT-An
text
C3641634 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Stem Cell Transplant (SCT) Follow-Up
C1504389 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Item
Source of Stem Cells:
text
C0449416 (UMLS CUI [1,1])
C0038250 (UMLS CUI [1,2])
Source of Stem Cells
Code List
Source of Stem Cells:
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])
Item
Method of Stem Cell Transplant
text
C1504389 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C1515895 (UMLS CUI [2])
Method of Stem Cell Transplant
Code List
Method of Stem Cell Transplant
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])
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])
Item Group
Total body irradiation
C0043162 (UMLS CUI-1)
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)
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])
Printed Name of Person Completing Form
Item
Printed Name of Person Completing Form
text
C1550483 (UMLS CUI [1,1])
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])
Item Group
Patient Assignment Sheet
C1955348 (UMLS CUI-1)
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Patient Assignment Sheet
C1955348 (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])
Item
Status (C/W)
text
C0449438 (UMLS CUI [1])
Status (C/W)
Code List
Status (C/W)
CL Item
Completed treatment and follow-up phases (C)
CL Item
Withdrawn prior to completing treatment and follow-up phases (W)
Item Group
Patient Log
C0030705 (UMLS CUI-1)
C2828389 (UMLS CUI-2)
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Item Group
Patient Log
C0030705 (UMLS CUI-1)
C2828389 (UMLS CUI-2)
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])
Item Group
Month of Report
C0439231 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
Month of Report
Item
Month of Report
integer
C0439231 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
Item Group
Outcome
C0085565 (UMLS CUI-1)
Item
Has the patient died?
text
C1546956 (UMLS CUI [1])
Patient Died
Code List
Has the patient died?
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])
Item
Has the disease progressed?
text
C0242656 (UMLS CUI [1])
Has the disease progressed?
Code List
Has the disease progressed?
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])
Item
Please mark box to indicate any post study cancer therapy received
text
C1882428 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Post Study Cancer Therapy
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])
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])
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])
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])
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])
Item Group
From D
C0011066 (UMLS CUI-1)
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
Cause of Death
Code List
Cause of Death
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])
If Yes to "Autopsy Done"
Item
If "Yes" please summarize findings (include diagnosis)
text
C0004398 (UMLS CUI [1,1])
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])
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
Cause of Death
Code List
Cause of Death
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])
Was an autopsy done?
Code List
Was an autopsy done?
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])
Item Group
Laboratory Reference Ranges
C0883335 (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])
Laboratory Name
Item
Laboratory Name
text
C1882331 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1])
Item Group
Referance Range
C0086715 (UMLS CUI-1)
Item
Referance - Gender
text
C0079399 (UMLS CUI [1])
Referance - Gender
Code List
Referance - Gender
CL Item
Male (1)
CL Item
Female (2)
Age Range
Item
Age Range
text
C0001779 (UMLS CUI [1,1])
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])
Hematology
Code List
Hematology (1-15), Blood Chemistry (16-34), Urinanalysis (35-41)
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])
High Reference Value
Item
High Reference Value
text
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
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