ID
37735
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 (1)
- 8/20/19 8/20/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 20, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308
Eligibility Criteria
- StudyEvent: ODM
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
The same contraceptive method should be used throughout the study and continue for at least 4 weeks after the end of the study. A woman will be considered to be of childbearing potential if she is not surgically sterile or post—menopausal (i.e., documented absence of menses for one year prior to entry into the study).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1960468
- UMLS CUI [1,2]
- C0700589
- UMLS CUI [2]
- C0009905
- UMLS CUI [3,1]
- C0042241
- UMLS CUI [3,2]
- C0037862
- UMLS CUI [4]
- C1706306
Description
Pregnancy; Breast Feeding
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Description
Histopathologic Grade | Borderline; Carcinoma; epithelial | Low Grade Malignant Neoplasm; Carcinoma; epithelial
Data type
boolean
Alias
- UMLS CUI [1]
- C0919553
- UMLS CUI [2,1]
- C0205189
- UMLS CUI [2,2]
- C0007097
- UMLS CUI [2,3]
- C0221908
- UMLS CUI [3,1]
- C1334425
- UMLS CUI [3,2]
- C0007097
- UMLS CUI [3,3]
- C0221908
Description
Prior Chemotherapy; Chemotherapy Regimen; Numbers
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1514457
- UMLS CUI [1,2]
- C0237753
Description
Comorbidity; Malignant Neoplasms | Basal cell carcinoma; Treating; Adequate | Squamous cell carcinoma of skin; Treating; Adequate | Carcinoma in situ of uterine cervix | Incidental Findings; Carcinoid Tumor | Disease; Free of (attribute)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0006826
- UMLS CUI [2,1]
- C0007117
- UMLS CUI [2,2]
- C1522326
- UMLS CUI [2,3]
- C0205411
- UMLS CUI [3,1]
- C0553723
- UMLS CUI [3,2]
- C1522326
- UMLS CUI [3,3]
- C0205411
- UMLS CUI [4]
- C0851140
- UMLS CUI [5,1]
- C0743997
- UMLS CUI [5,2]
- C0007095
- UMLS CUI [6,1]
- C0012634
- UMLS CUI [6,2]
- C0332296
Description
Communicable Diseases; Requirement; Antibiotic therapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C1514873
- UMLS CUI [1,3]
- C0338237
Description
Comorbidity; Severe (severity modifier); Malignant Neoplasms; Unrelated (finding) | Compliance behavior | Risk; Extreme | Life Expectancy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0205082
- UMLS CUI [1,3]
- C0006826
- UMLS CUI [1,4]
- C0445356
- UMLS CUI [2]
- C1321605
- UMLS CUI [3,1]
- C0035647
- UMLS CUI [3,2]
- C0205403
- UMLS CUI [4]
- C0023671
Description
Therapeutic radiology procedure | Bone Marrow
Data type
boolean
Alias
- UMLS CUI [1]
- C1522449
- UMLS CUI [2]
- C0005953
Description
Concomitant Agent; Chemotherapeutic agent | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Operative Surgical Procedures | cancer treatment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0729502
- UMLS CUI [2]
- C0021083
- UMLS CUI [3]
- C0279025
- UMLS CUI [4]
- C1522449
- UMLS CUI [5]
- C0543467
- UMLS CUI [6]
- C0920425
Description
Prior Therapy | Topotecan | gemcitabine
Data type
boolean
Alias
- UMLS CUI [1]
- C1514463
- UMLS CUI [2]
- C0146224
- UMLS CUI [3]
- C0045093
Description
Camptothecin; Hypersensitivity | Nucleoside Analogs; Hypersensitivity | Compound (substance); Relationships
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0006812
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [2,1]
- C1579410
- UMLS CUI [2,2]
- C0020517
- UMLS CUI [3,1]
- C1706082
- UMLS CUI [3,2]
- C0439849
Description
INVESTIGATIONAL AGENTS; Before; Clinical Trial Period
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1875319
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Description
Did the patient meet all inclusion and exclusion criteria?
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0001779 (UMLS CUI [2])
C0011900 (UMLS CUI [1,2])
C0677886 (UMLS CUI [2])
C0238122 (UMLS CUI [3])
C1514428 (UMLS CUI [4])
C0206627 (UMLS CUI [5])
C0392920 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0079083 (UMLS CUI [3])
C0008838 (UMLS CUI [4])
C0277554 (UMLS CUI [5])
C1513040 (UMLS CUI [1,2])
C1705052 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C0332324 (UMLS CUI [1,2])
C1512288 (UMLS CUI [2])
C1272706 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0521982 (UMLS CUI [4,1])
C0032207 (UMLS CUI [4,2])
C1522449 (UMLS CUI [2])
C1513041 (UMLS CUI [3,1])
C0450429 (UMLS CUI [3,2])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C0042241 (UMLS CUI [3,1])
C0037862 (UMLS CUI [3,2])
C1706306 (UMLS CUI [4])
C0006147 (UMLS CUI [1,2])
C0205189 (UMLS CUI [2,1])
C0007097 (UMLS CUI [2,2])
C0221908 (UMLS CUI [2,3])
C1334425 (UMLS CUI [3,1])
C0007097 (UMLS CUI [3,2])
C0221908 (UMLS CUI [3,3])
C0237753 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4])
C0743997 (UMLS CUI [5,1])
C0007095 (UMLS CUI [5,2])
C0012634 (UMLS CUI [6,1])
C0332296 (UMLS CUI [6,2])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0445356 (UMLS CUI [1,4])
C1321605 (UMLS CUI [2])
C0035647 (UMLS CUI [3,1])
C0205403 (UMLS CUI [3,2])
C0023671 (UMLS CUI [4])
C0005953 (UMLS CUI [2])
C0729502 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0920425 (UMLS CUI [6])
C0146224 (UMLS CUI [2])
C0045093 (UMLS CUI [3])
C0020517 (UMLS CUI [1,2])
C1579410 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C1706082 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0680251 (UMLS CUI-2)
C0680251 (UMLS CUI [1,2])