ID
37618
Description
Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer
Keywords
Versions (2)
- 8/11/19 8/11/19 -
- 9/17/21 9/17/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 11, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612
Baseline
- StudyEvent: ODM
Description
Date
Alias
- UMLS CUI-1
- C2985720
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Patient date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body Surface Area
Data type
float
Measurement units
- m2
Alias
- UMLS CUI [1]
- C0005902
Description
Menopausal status
Alias
- UMLS CUI-1
- C1513126
Description
Menopausal Status
Data type
text
Alias
- UMLS CUI [1]
- C1513126
Description
Contraceptive methods
Data type
boolean
Alias
- UMLS CUI [1]
- C0700589
Description
Contraceptive methods
Data type
text
Alias
- UMLS CUI [1]
- C0700589
Description
Medical History
Alias
- UMLS CUI-1
- C0262926
Description
body system or organ function
Data type
text
Alias
- UMLS CUI [1]
- C0678852
Description
Medical History
Data type
boolean
Alias
- UMLS CUI [1]
- C0262926
Description
Medical History, Current, Previous
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0521116
- UMLS CUI [1,3]
- C0205156
Description
Medical History, Specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1521902
Description
Symptoms at study start
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C2348558
Description
Symptoms, Study Start Date
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
Description
Symptoms, Study Start Date
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
Description
Symptoms, Study Start Date, Symptom Intensity
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
- UMLS CUI [1,3]
- C0518690
Description
Symptoms, Study Start Date, Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
- UMLS CUI [1,3]
- C0947611
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Concomitant Agent
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Concomitant Agent, Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Description
Concomitant Medication Daily Dose
Data type
text
Alias
- UMLS CUI [1]
- C2826638
Description
Concomitant Agent, Drug Administration Routes
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Description
Concomitant Agent, Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3146298
Description
Concomitant Medication Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant Medication End Date
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Concomitant Medication Ongoing
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Assessment of performance status
Alias
- UMLS CUI-1
- C1520224
Description
Tumor history
Alias
- UMLS CUI-1
- C0260455
Description
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0677886
Description
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer, FIGO stage
Data type
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0677886
- UMLS CUI [1,3]
- C0450454
Description
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer, FIGO stage
Data type
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0677886
- UMLS CUI [1,3]
- C0450454
Description
Personal history of malignant neoplasm, unspecified, Peritoneal Cancer Index
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C4049621
Description
Personal history of malignant neoplasm, unspecified, Ascites
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0003962
Description
Personal history of malignant neoplasm, unspecified, Secondary malignant neoplasm of lymph node, Palpable
Data type
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0686619
- UMLS CUI [1,3]
- C0522499
Description
Personal history of malignant neoplasm, unspecified, Secondary malignant neoplasm of lymph node, Histological finding
Data type
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0686619
- UMLS CUI [1,3]
- C0449575
Description
Histology
Alias
- UMLS CUI-1
- C0029925
- UMLS CUI-2
- C0019638
Description
Ovarian Carcinoma, Histology
Data type
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0019638
Description
Ovarian Carcinoma, Histology
Data type
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0019638
Description
Ovarian Carcinoma, Histology, Histopathologic Grade
Data type
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0019638
- UMLS CUI [1,3]
- C0919553
Description
Surgery of Ovarian Carcinoma
Alias
- UMLS CUI-1
- C0029925
- UMLS CUI-2
- C0543467
Description
Ovarian Carcinoma, Operative Surgical Procedures, Date in time
Data type
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0011008
Description
Ovarian Carcinoma, Operative Surgical Procedures, Surgical approach
Data type
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0449446
Description
Ovarian Carcinoma, Operative Surgical Procedures, Anatomic structure
Data type
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0700276
Description
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Left
Data type
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0205091
Description
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Previously
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0205156
Description
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0011008
Description
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0566251
Description
Tumor metrics
Alias
- UMLS CUI-1
- C1300072
Description
Tumor stage, Neoplasm Metastasis, maximum, Preoperative
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [1,4]
- C0445204
Description
Tumor stage, Neoplasm Metastasis, maximum, Postoperative Period
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [1,4]
- C0032790
Description
Tumor stage, Lesion, Postoperative Period
Data type
integer
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0032790
Description
Tumor stage, Postoperative Period, Malignant Neoplasm, Measurable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0006826
- UMLS CUI [1,4]
- C1513040
Description
Tumor stage, Postoperative Period, Malignant Neoplasm, Evaluation method
Data type
text
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0006826
- UMLS CUI [1,4]
- C2911685
Description
Tumor stage, Postoperative Period, Malignant Neoplasm, Assessment Date
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0006826
- UMLS CUI [1,4]
- C2985720
Description
Tumor markers
Alias
- UMLS CUI-1
- C0041365
Description
Tumor Markers
Data type
text
Alias
- UMLS CUI [1]
- C0041365
Description
Tumor Markers, Assessment Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C2985720
Description
Tumor Markers, Numerical value
Data type
integer
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C1522609
Description
Tumor Markers, Unit of Measure
Data type
text
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C1519795
Description
Tumor Markers, Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C0947611
Description
Examination of the lower abdomen
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0230166
Description
Physical Examination, Pelvis, Finding
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
- UMLS CUI [1,3]
- C0243095
Description
Physical Examination, Pelvis, Finding
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
- UMLS CUI [1,3]
- C0243095
Description
Physical Examination, Pelvis, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
- UMLS CUI [1,3]
- C0011008
Description
Physical Examination, Vagina, Finding
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0042232
- UMLS CUI [1,3]
- C0243095
Description
Physical Examination, Vagina, Finding
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0042232
- UMLS CUI [1,3]
- C0243095
Description
Physical Examination, Vagina, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0042232
- UMLS CUI [1,3]
- C0011008
Description
Physical Examination, Rectum, Findings
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0034896
- UMLS CUI [1,3]
- C0243095
Description
Physical Examination, Rectum, Findings
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0034896
- UMLS CUI [1,3]
- C0243095
Description
Physical Examination, Rectum, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0034896
- UMLS CUI [1,3]
- C0011008
Description
Computed tomography
Alias
- UMLS CUI-1
- C0040405
Description
X-Ray Computed Tomography, Finding
Data type
text
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0243095
Description
X-Ray Computed Tomography, Finding
Data type
text
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0243095
Description
X-Ray Computed Tomography, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0011008
Description
X-ray
Alias
- UMLS CUI-1
- C1306645
Description
Plain x-ray, Finding
Data type
text
Alias
- UMLS CUI [1,1]
- C1306645
- UMLS CUI [1,2]
- C0243095
Description
Plain x-ray, Finding
Data type
text
Alias
- UMLS CUI [1,1]
- C1306645
- UMLS CUI [1,2]
- C0243095
Description
Plain x-ray, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C1306645
- UMLS CUI [1,2]
- C0011008
Description
ECG
Alias
- UMLS CUI-1
- C1623258
Description
Electrocardiography, Finding
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0243095
Description
Electrocardiography, Finding
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0243095
Description
Electrocardiography, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0011008
Description
Quality-of-life questionnaire
Alias
- UMLS CUI-1
- C0034394
- UMLS CUI-2
- C0034380
Description
Questionnaires, Quality of life, Compliance behavior
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1321605
Description
Questionnaires, Quality of life, Compliance behavior, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1321605
- UMLS CUI [1,4]
- C0566251
Description
Questionnaires, Quality of life, Supportive assistance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1521721
Description
Questionnaires, Quality of life, Supportive assistance, Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1521721
- UMLS CUI [1,4]
- C0027365
Description
Receptors
Alias
- UMLS CUI-1
- C0597357
Similar models
Baseline
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C2348558 (UMLS CUI-2)
C2348558 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C2348558 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C0677886 (UMLS CUI [1,2])
C0677886 (UMLS CUI [1,2])
C0450454 (UMLS CUI [1,3])
C0677886 (UMLS CUI [1,2])
C0450454 (UMLS CUI [1,3])
C4049621 (UMLS CUI [1,2])
C0003962 (UMLS CUI [1,2])
C0686619 (UMLS CUI [1,2])
C0522499 (UMLS CUI [1,3])
C0686619 (UMLS CUI [1,2])
C0449575 (UMLS CUI [1,3])
C0019638 (UMLS CUI [1,2])
C0019638 (UMLS CUI [1,2])
C0019638 (UMLS CUI [1,2])
C0919553 (UMLS CUI [1,3])
C0543467 (UMLS CUI-2)
C0543467 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C0449446 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C0700276 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C0849355 (UMLS CUI [1,3])
C0205091 (UMLS CUI [1,4])
C0543467 (UMLS CUI [1,2])
C0849355 (UMLS CUI [1,3])
C0205156 (UMLS CUI [1,4])
C0543467 (UMLS CUI [1,2])
C0849355 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0543467 (UMLS CUI [1,2])
C0849355 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0027627 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0445204 (UMLS CUI [1,4])
C0027627 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0032790 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1513040 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2985720 (UMLS CUI [1,4])
C2985720 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0230166 (UMLS CUI-2)
C0030797 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0030797 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0030797 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0042232 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0042232 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0042232 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0034896 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0034896 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0034896 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0034380 (UMLS CUI-2)
C0034380 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0034380 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0034380 (UMLS CUI [1,2])
C1521721 (UMLS CUI [1,3])
C0034380 (UMLS CUI [1,2])
C1521721 (UMLS CUI [1,3])
C0027365 (UMLS CUI [1,4])