ID

37921

Beschreibung

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

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Versionen (1)
  1. 30.08.19 30.08.19 -
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GlaxoSmithKline

Hochgeladen am

30. August 2019

DOI

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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

Englisch

Course 2 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
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]
C1709561
Patient ID
Beschreibung

Patient ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Review of Disease Status
Beschreibung

Review of Disease Status

Alias
UMLS CUI-1
C0699749
UMLS CUI-2
C0699752
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Assessment not done
Beschreibung

Assessment not done

Datentyp

integer

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1272696
Reason for assessment not done
Beschreibung

Mark only one

Datentyp

integer

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C2826287
Date of Progression
Beschreibung

Date of Progression

Datentyp

date

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

Mark one

Datentyp

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1516048
UMLS CUI [2]
C4534461
Therapeutic Interventions
Beschreibung

Therapeutic Interventions

Alias
UMLS CUI-1
C0808232
Were any therapeutic interventions administered during this course to ameliorate toxicities associated with study drug?
Beschreibung

If “Yes", complete Therapeutic Interventions log.

Datentyp

boolean

Alias
UMLS CUI [1]
C0808232
UMLS CUI [2,1]
C0013221
UMLS CUI [2,2]
C0304229
End of Course Eligibility
Beschreibung

End of Course Eligibility

Alias
UMLS CUI-1
C0013893
UMLS CUI-2
C0750729
UMLS CUI-3
C0444930
Did the patient meet the following criteria by Day 28?
Beschreibung

Hemoglobin >= 9.0 g/dL [90 g/L] Neutrophils >= 1000 cells/mm3 [>= 1.0 x 10*9 /L] Platelets >= 100,000/mm3 [>= 100.0 x 10*9 /L] No clinically significant non-hematologic drug related toxicity If "Yes“, proceed to next course. If "No”, complete Unscheduled Laboratory Tests on pages 20-21.

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
Unscheduled Laboratory Tests - Hematology
Beschreibung

Unscheduled Laboratory Tests - Hematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C3854240
UMLS CUI-3
C0474523
Hematology Sample Date
Beschreibung

Hematology Sample Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1302413
Hematology Laboratory Name
Beschreibung

Hematology Laboratory Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C3258037
Unscheduled Laboratory Tests - Hematology
Beschreibung

Unscheduled Laboratory Tests - Hematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C3854240
UMLS CUI-3
C0474523
Hematology Test
Beschreibung

Hematology Test

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Hematology - No Result
Beschreibung

Hematology - No Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
Hematology - Value
Beschreibung

Hematology - Value

Datentyp

text

Alias
UMLS CUI [1]
C0474523
Hematology - Value out of range and NOT clinically significant
Beschreibung

Hematology - Value out of range and NOT clinically significant

Datentyp

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0438215
UMLS CUI [1,3]
C2826293
Hematology - Value out of range and clinically significant
Beschreibung

Hematology - Value out of range and clinically significant

Datentyp

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0438215
UMLS CUI [1,3]
C2826293
Therapeutic Interventions
Beschreibung

Therapeutic Interventions

Alias
UMLS CUI-1
C0808232
Line Number
Beschreibung

Line Number

Datentyp

integer

Alias
UMLS CUI [1]
C0449788
Procedure
Beschreibung

Procedure

Datentyp

text

Alias
UMLS CUI [1]
C2700391
Procedure details
Beschreibung

Procedure details

Datentyp

text

Alias
UMLS CUI [1,1]
C2700391
UMLS CUI [1,2]
C1522508
Procedure Time
Beschreibung

Procedure Time

Datentyp

time

Alias
UMLS CUI [1,1]
C2700391
UMLS CUI [1,2]
C0040223
Procedure Date
Beschreibung

Procedure Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2700391
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Course 2 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (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
C1709561 (UMLS CUI [1])
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item Group
Review of Disease Status
C0699749 (UMLS CUI-1)
C0699752 (UMLS CUI-2)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Assessment not done
integer
C0220825 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Assessment not done
Code List
Assessment not done
CL Item
Not Done (1)
Item
Reason for assessment not done
integer
C0220825 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Reason for assessment not done
Code List
Reason for assessment not done
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])
C1516048 (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
Therapeutic Interventions
C0808232 (UMLS CUI-1)
Were any therapeutic interventions administered during this course to ameliorate toxicities associated with study drug?
Item
Were any therapeutic interventions administered during this course to ameliorate toxicities associated with study drug?
boolean
C0808232 (UMLS CUI [1])
C0013221 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Item Group
End of Course Eligibility
C0013893 (UMLS CUI-1)
C0750729 (UMLS CUI-2)
C0444930 (UMLS CUI-3)
Did the patient meet the following criteria by Day 28?
Item
Did the patient meet the following criteria by Day 28?
boolean
C0013893 (UMLS CUI [1])
Item Group
Unscheduled Laboratory Tests - Hematology
C0022885 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0474523 (UMLS CUI-3)
Hematology Sample Date
Item
Hematology Sample Date
date
C0474523 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Hematology Laboratory Name
Item
Hematology Laboratory Name
text
C0474523 (UMLS CUI [1,1])
C3258037 (UMLS CUI [1,2])
Item Group
Unscheduled Laboratory Tests - Hematology
C0022885 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0474523 (UMLS CUI-3)
Item
Hematology Test
integer
C0018941 (UMLS CUI [1])
Haematology Test
Code List
Hematology Test
CL Item
Hemoglobin  (1)
CL Item
Hematocrit  (2)
CL Item
RBC  (3)
CL Item
WBC  (4)
CL Item
Neutrophils  (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
Granulocytes (12)
Item
Hematology - No Result
integer
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Haematology - No Result
Code List
Hematology - No Result
CL Item
No Result (1)
Hematology - Value
Item
Hematology - Value
text
C0474523 (UMLS CUI [1])
Item
Hematology - Value out of range and NOT clinically significant
integer
C0474523 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Haematology - Value out of range and NOT clinically significant
Code List
Hematology - Value out of range and NOT clinically significant
CL Item
Value out of range and NOT clinically significant (2)
Item
Hematology - Value out of range and clinically significant
integer
C0474523 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Haematology - Value out of range and clinically significant
Code List
Hematology - Value out of range and clinically significant
CL Item
Value out of range and clinically significant (3)
Item Group
Therapeutic Interventions
C0808232 (UMLS CUI-1)
Line Number
Item
Line Number
integer
C0449788 (UMLS CUI [1])
Procedure
Item
Procedure
text
C2700391 (UMLS CUI [1])
Procedure details
Item
Procedure details
text
C2700391 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Procedure Time
Item
Procedure Time
time
C2700391 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Procedure Date
Item
Procedure Date
date
C2700391 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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