ID

37973

Descrição

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Palavras-chave

Versões (1)
  1. 03/09/2019 03/09/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

3 de setembro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

Inglês

Survival Information; Form D; Termination Record

1 Formulários  
Survival Information - Month of Report
Descrição

Survival Information - Month of Report

Alias
UMLS CUI-1
C0038953
UMLS CUI-2
C0439231
UMLS CUI-3
C0684224
Please mark the appropriate box to indicate month of report
Descrição

Please mark the appropriate box to indicate month of report

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0439231
UMLS CUI [1,2]
C0684224
If other month of report, specify
Descrição

If other month of report, specify

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0439231
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Survival Information - Review of disease status
Descrição

Survival Information - Review of disease status

Alias
UMLS CUI-1
C0038953
UMLS CUI-2
C0012634
UMLS CUI-3
C0449438
Date of Assessment
Descrição

Date of Assessment

Tipo de dados

date

Alias
UMLS CUI [1]
C2985720
Disease status
Descrição

Mark only one.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Date of Progression
Descrição

Date of Progression

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0011008
Lesion Evaluation or Clinical Assessment
Descrição

Lesion Evaluation or Clinical Assessment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0220825
UMLS CUI [2]
C4534461
Survival Information - Outcome
Descrição

Survival Information - Outcome

Alias
UMLS CUI-1
C0038953
UMLS CUI-2
C1547647
Has the patient died?
Descrição

If "Yes", complete FORM D

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011065
If patient did not die, Date of last contact
Descrição

If patient did not die, Date of last contact

Tipo de dados

date

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

Was the patient lost to follow-up?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1302313
Form D
Descrição

Form D

Alias
UMLS CUI-1
C0011065
Primary Cause of Death
Descrição

Primary Cause of Death

Tipo de dados

integer

Alias
UMLS CUI [1]
C0007465
If Progressive Disease, specify details
Descrição

If Progressive Disease, specify details

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C1522508
If Toxicity, specify details
Descrição

If Toxicity, specify details

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0040539
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C1522508
If other cause of Death, specify
Descrição

If other cause of Death, specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Date of Death
Descrição

Date of Death

Tipo de dados

date

Alias
UMLS CUI [1]
C1148348
Was an Autopsy performed?
Descrição

Was an Autopsy performed?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0884358
If Autopsy was performed, please summarize findings
Descrição

Include diagnosis

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0243095
Investigator's Signauture
Descrição

I certify that I have reviewed the follow-up data and that all information is complete and accurate

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Date of Investigator's Signature
Descrição

Date of Investigator's Signature

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Termination Record
Descrição

Termination Record

Alias
UMLS CUI-1
C0871548
Date of last dose of study medication
Descrição

Date of last dose of study medication

Tipo de dados

date

Alias
UMLS CUI [1]
C1762893
Date of last visit
Descrição

Date of last visit

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C1517741
Termination Record - Review of Disease Status
Descrição

Termination Record - Review of Disease Status

Alias
UMLS CUI-1
C0871548
UMLS CUI-2
C0012634
UMLS CUI-3
C0449438
Date of Assessment
Descrição

Date of Assessment

Tipo de dados

date

Alias
UMLS CUI [1]
C2985720
Disease status
Descrição

Mark only one.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Date of Progression
Descrição

Date of Progression

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0011008
Lesion Evaluation or Clinical Assessment
Descrição

Lesion Evaluation or Clinical Assessment

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0220825
UMLS CUI [2]
C4534461
Termination Record - Best Overall Response
Descrição

Termination Record - Best Overall Response

Alias
UMLS CUI-1
C0871548
UMLS CUI-2
C2986560
Please indicate Best Overall Response
Descrição

Please indicate Best Overall Response

Tipo de dados

integer

Alias
UMLS CUI [1]
C2986560
Termination Record - Study Conclusion
Descrição

Termination Record - Study Conclusion

Alias
UMLS CUI-1
C0871548
UMLS CUI-2
C1707478
UMLS CUI-3
C0008972
Mark the primary cause of study conclusion
Descrição

Mark the primary cause of study conclusion

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0085978
If other cause of study conclusion, specify
Descrição

If other cause of study conclusion, specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Termination Record - Investigator Signature
Descrição

Termination Record - Investigator Signature

Alias
UMLS CUI-1
C0871548
UMLS CUI-2
C2346576
Investigator's Signature
Descrição

I certify that I have reviewed the data on the case report form, including laboratory data, and the Adverse Event and Serious Adverse Event sections, and that all information is complete and accurate.

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature - Date Signed
Descrição

Investigator's Signature - Date Signed

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Survival Information; Form D; Termination Record

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Survival Information - Month of Report
C0038953 (UMLS CUI-1)
C0439231 (UMLS CUI-2)
C0684224 (UMLS CUI-3)
Item
Please mark the appropriate box to indicate month of report
integer
C0439231 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
Please mark the appropriate box to indicate month of report
Code List
Please mark the appropriate box to indicate month of report
CL Item
3 (1)
CL Item
6 (2)
CL Item
9 (3)
CL Item
12 (4)
CL Item
15 (5)
CL Item
18 (6)
CL Item
21 (7)
CL Item
24 (8)
CL Item
Other, specify (9)
If other month of report, specify
Item
If other month of report, specify
integer
C0439231 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Survival Information - Review of disease status
C0038953 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Disease status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Disease status
Code List
Disease status
CL Item
Not Applicable (disease progression previously established) (1)
CL Item
Non-evaluable (2)
CL Item
Complete Response (3)
CL Item
Partial Response (4)
CL Item
Stable Disease (5)
CL Item
Disease Progression (6)
Date of Progression
Item
Date of Progression
date
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Lesion Evaluation or Clinical Assessment
text
C0221198 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C4534461 (UMLS CUI [2])
Lesion Evaluation or Clinical Assessment
Code List
Lesion Evaluation or Clinical Assessment
CL Item
Lesion Evaluation (1)
CL Item
Clinical Assessment (2)
Item Group
Survival Information - Outcome
C0038953 (UMLS CUI-1)
C1547647 (UMLS CUI-2)
Has the patient died?
Item
Has the patient died?
boolean
C0011065 (UMLS CUI [1])
If patient did not die, Date of last contact
Item
If patient did not die, Date of last contact
date
C0805839 (UMLS CUI [1])
Was the patient lost to follow-up?
Item
Was the patient lost to follow-up?
boolean
C1302313 (UMLS CUI [1])
Item Group
Form D
C0011065 (UMLS CUI-1)
Item
Primary Cause of Death
integer
C0007465 (UMLS CUI [1])
Primary Cause of Death
Code List
Primary Cause of Death
CL Item
Progressive Disease, specify details (1)
CL Item
Toxicity, specify details (2)
CL Item
Other, specify (3)
If Progressive Disease, specify details
Item
If Progressive Disease, specify details
text
C1335499 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
If Toxicity, specify details
Item
If Toxicity, specify details
text
C0040539 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
If other cause of Death, specify
Item
If other cause of Death, specify
text
C0007465 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Was an Autopsy performed?
Item
Was an Autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
If Autopsy was performed, please summarize findings
Item
If Autopsy was performed, please summarize findings
text
C0004398 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Investigator's Signauture
Item
Investigator's Signauture
text
C2346576 (UMLS CUI [1])
Date of Investigator's Signature
Item
Date of Investigator's Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Termination Record
C0871548 (UMLS CUI-1)
Date of last dose of study medication
Item
Date of last dose of study medication
date
C1762893 (UMLS CUI [1])
Date of last visit
Item
Date of last visit
date
C1320303 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Item Group
Termination Record - Review of Disease Status
C0871548 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Disease status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Disease status
Code List
Disease status
CL Item
Non-evaluable  (1)
CL Item
Complete Response  (2)
CL Item
Partial Response  (3)
CL Item
Stable Disease  (4)
CL Item
Disease Progression (5)
Date of Progression
Item
Date of Progression
date
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Lesion Evaluation or Clinical Assessment
integer
C0221198 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C4534461 (UMLS CUI [2])
Lesion Evaluation or Clinical Assessment
Code List
Lesion Evaluation or Clinical Assessment
CL Item
Lesion Evaluation  (1)
CL Item
Clinical Assessment (2)
Item Group
Termination Record - Best Overall Response
C0871548 (UMLS CUI-1)
C2986560 (UMLS CUI-2)
Item
Please indicate Best Overall Response
integer
C2986560 (UMLS CUI [1])
Please indicate Best Overall Response
Code List
Please indicate Best Overall Response
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
CL Item
Non-evaluable for response (5)
Item Group
Termination Record - Study Conclusion
C0871548 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
Item
Mark the primary cause of study conclusion
integer
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Mark the primary cause of study conclusion
Code List
Mark the primary cause of study conclusion
CL Item
Adverse Event (complete Adverse Event Case Report Form.)  (1)
CL Item
Progressive Disease (ie Lack of Efficacy)  (2)
CL Item
Protocol deviation (including non-compliance)  (3)
CL Item
Lost to follow-up  (4)
CL Item
Death - Please complete the Death Report form (Form D).  (5)
CL Item
Patient withdrawn at her own request, for reasons other that those above.  (6)
CL Item
Other, specify (7)
If other cause of study conclusion, specify
Item
If other cause of study conclusion, specify
text
C0008972 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Termination Record - Investigator Signature
C0871548 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature - Date Signed
Item
Investigator's Signature - Date Signed
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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