ID
37771
Description
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
Keywords
Versions (2)
- 8/23/19 8/23/19 -
- 8/23/19 8/23/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 23, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308
Screening - Prior Ovarian Cancer Treatment; Laboratory Tests; Lesion Assessment Record
Description
Prior Ovarian Cancer Treatment - Chemotherapy
Alias
- UMLS CUI-1
- C0029925
- UMLS CUI-2
- C0920425
- UMLS CUI-3
- C0392920
Description
Line No.
Data type
integer
Alias
- UMLS CUI [1]
- C0750480
Description
Chemo Agent
Data type
text
Alias
- UMLS CUI [1]
- C0013216
Description
Chemotherapy Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0808070
Description
Chemotherapy End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0806020
Description
Overall response
Data type
integer
Alias
- UMLS CUI [1]
- C3272903
Description
Has the patient received radiotherapy?
Alias
- UMLS CUI-1
- C1522449
Description
Prior Ovarian Cancer Treatment - Radiotherapy
Alias
- UMLS CUI-1
- C0029925
- UMLS CUI-2
- C0920425
- UMLS CUI-3
- C1522449
Description
Line No.
Data type
integer
Alias
- UMLS CUI [1]
- C0750480
Description
Radiotherapy - Specify Area
Data type
text
Alias
- UMLS CUI [1]
- C1997599
Description
Radiotherapy - Dose Received
Data type
text
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C3174092
Description
Radiotherapy - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0011008
Description
Has the patient received prior cancer-related surgery?
Alias
- UMLS CUI-1
- C0543467
- UMLS CUI-2
- C0205156
- UMLS CUI-3
- C2826292
Description
Prior Ovarian Cancer Treatment - Surgical Treatment
Alias
- UMLS CUI-1
- C0029925
- UMLS CUI-2
- C0920425
- UMLS CUI-3
- C0543467
Description
Has the patient received other cancer-related treatments?
Alias
- UMLS CUI-1
- C0920425
- UMLS CUI-2
- C0205394
Description
Other Cancer Related Treatments
Alias
- UMLS CUI-1
- C0920425
- UMLS CUI-2
- C0205394
Description
Line No.
Data type
integer
Alias
- UMLS CUI [1]
- C0750480
Description
Treatment
Data type
text
Alias
- UMLS CUI [1]
- C0087111
Description
Treatment Start Date
Data type
date
Alias
- UMLS CUI [1]
- C3173309
Description
Treatment End Date
Data type
date
Alias
- UMLS CUI [1]
- C1531784
Description
Laboratory Tests (within 7 days prior to Day 1) - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Description
Laboratory Tests (within 7 days prior to Day 1) - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Description
Haematology Test
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Haematology - No Result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Description
Haematology - Value
Data type
text
Alias
- UMLS CUI [1]
- C0474523
Description
Haematology - Value out of range and NOT clinically significant
Data type
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0438215
- UMLS CUI [1,3]
- C2826293
Description
Haematology - Value out of range and clinically significant
Data type
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0438215
- UMLS CUI [1,3]
- C2826293
Description
Laboratory Tests (within 7 days prior to Day 1) - Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Description
Laboratory Tests (within 7 days prior to Day 1) - Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Description
Chemistry - Test
Data type
integer
Alias
- UMLS CUI [1]
- C0525044
Description
Chemistry - No Result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
Description
Chemistry - Value
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
Description
Chemistry - Value out of range and NOT clinically significant
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0438215
- UMLS CUI [1,4]
- C2826293
Description
Chemistry - Value out of range and NOT clinically significant
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0438215
- UMLS CUI [1,4]
- C2826293
Description
Lesion Assessment Record
Alias
- UMLS CUI-1
- C0221198
- UMLS CUI-2
- C1516048
Description
Lesion No.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0221198
Description
Lesion Site Code
Data type
integer
Alias
- UMLS CUI [1,1]
- C0449695
- UMLS CUI [1,2]
- C0805701
Description
Lesion Site Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0449695
- UMLS CUI [1,2]
- C0678257
Description
Lesion Measurement - Method Code
Data type
integer
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2911685
- UMLS CUI [1,4]
- C0805701
Description
Lesion Measurement - Date Performed
Data type
date
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0011008
Description
Measurable/ Non measurable Lesion Code
Data type
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1513040
- UMLS CUI [2]
- C1334988
Description
Lesion Size - 1. Diameter (cm)
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0449453
- UMLS CUI [1,2]
- C1301886
Description
Lesion Size - 2. Diameter (cm)
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0449453
- UMLS CUI [1,2]
- C1301886
Description
Lesion Non-Evaluable
Data type
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1883425
Description
Lesion Non-Evaluable - Lesion Measurement Method Code
Data type
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1883425
- UMLS CUI [1,3]
- C1299991
- UMLS CUI [1,4]
- C0805701
Description
Lesion Non-Evaluable - Date Performed
Data type
date
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1883425
- UMLS CUI [1,3]
- C0011008
Description
Lesion Non-Evaluable Status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1883425
- UMLS CUI [1,3]
- C0449438
Similar models
Screening - Prior Ovarian Cancer Treatment; Laboratory Tests; Lesion Assessment Record
C0019994 (UMLS CUI [1,2])
C0920425 (UMLS CUI-2)
C0392920 (UMLS CUI-3)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0920425 (UMLS CUI-2)
C1522449 (UMLS CUI-3)
C3174092 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0205156 (UMLS CUI-2)
C2826292 (UMLS CUI-3)
C0205156 (UMLS CUI [1,2])
C2826292 (UMLS CUI [1,3])
C0920425 (UMLS CUI-2)
C0543467 (UMLS CUI-3)
C0332307 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI-2)
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C1516048 (UMLS CUI-2)
C0221198 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513040 (UMLS CUI [1,2])
C1334988 (UMLS CUI [2])
C1301886 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,2])
C1883425 (UMLS CUI [1,2])
C1883425 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C1883425 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1883425 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])