ID
43040
Beschrijving
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
Trefwoorden
Versies (2)
- 11-08-19 11-08-19 -
- 17-09-21 17-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
17 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Date
Alias
- UMLS CUI-1
- C2985720
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Patient date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Body Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Body Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Body Surface Area
Datatype
float
Maateenheden
- m2
Alias
- UMLS CUI [1]
- C0005902
Beschrijving
Menopausal status
Alias
- UMLS CUI-1
- C3829127
Beschrijving
Menopausal Status
Datatype
text
Alias
- UMLS CUI [1]
- C3829127
Beschrijving
Contraceptive methods
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
Contraceptive methods
Datatype
text
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
Medical History
Alias
- UMLS CUI-1
- C0262926
Beschrijving
body system or organ function
Datatype
text
Alias
- UMLS CUI [1]
- C0678852
Beschrijving
Medical History
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262926
Beschrijving
Medical History, Current, Previous
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0521116
- UMLS CUI [1,3]
- C0205156
Beschrijving
Medical History, Specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1521902
Beschrijving
Symptoms at study start
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C2348558
Beschrijving
Symptoms, Study Start Date
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
Beschrijving
Symptoms, Study Start Date
Datatype
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
Beschrijving
Symptoms, Study Start Date, Symptom Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
- UMLS CUI [1,3]
- C0518690
Beschrijving
Symptoms, Study Start Date, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
- UMLS CUI [1,3]
- C0947611
Beschrijving
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant Agent
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Concomitant Agent, Medication name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschrijving
Concomitant Medication Daily Dose
Datatype
text
Alias
- UMLS CUI [1]
- C2826638
Beschrijving
Concomitant Agent, Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Beschrijving
Concomitant Agent, Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3146298
Beschrijving
Concomitant Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Concomitant Medication End Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Concomitant Medication Ongoing
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Assessment of performance status
Alias
- UMLS CUI-1
- C1520224
Beschrijving
Tumor history
Alias
- UMLS CUI-1
- C0260455
Beschrijving
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0677886
Beschrijving
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer, FIGO stage
Datatype
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0677886
- UMLS CUI [1,3]
- C0450454
Beschrijving
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer, FIGO stage
Datatype
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0677886
- UMLS CUI [1,3]
- C0450454
Beschrijving
Personal history of malignant neoplasm, unspecified, Peritoneal Cancer Index
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C4049621
Beschrijving
Personal history of malignant neoplasm, unspecified, Ascites
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0003962
Beschrijving
Personal history of malignant neoplasm, unspecified, Secondary malignant neoplasm of lymph node, Palpable
Datatype
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0686619
- UMLS CUI [1,3]
- C0522499
Beschrijving
Personal history of malignant neoplasm, unspecified, Secondary malignant neoplasm of lymph node, Histological finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0686619
- UMLS CUI [1,3]
- C0449575
Beschrijving
Histology
Alias
- UMLS CUI-1
- C0029925
- UMLS CUI-2
- C0019638
Beschrijving
Ovarian Carcinoma, Histology
Datatype
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0019638
Beschrijving
Ovarian Carcinoma, Histology
Datatype
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0019638
Beschrijving
Ovarian Carcinoma, Histology, Histopathologic Grade
Datatype
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0019638
- UMLS CUI [1,3]
- C0919553
Beschrijving
Surgery of Ovarian Carcinoma
Alias
- UMLS CUI-1
- C0029925
- UMLS CUI-2
- C0543467
Beschrijving
Ovarian Carcinoma, Operative Surgical Procedures, Date in time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0011008
Beschrijving
Ovarian Carcinoma, Operative Surgical Procedures, Surgical approach
Datatype
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0449446
Beschrijving
Ovarian Carcinoma, Operative Surgical Procedures, Anatomic structure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0700276
Beschrijving
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Left
Datatype
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0205091
Beschrijving
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Previously
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0205156
Beschrijving
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0011008
Beschrijving
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Reason and justification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0566251
Beschrijving
Tumor metrics
Alias
- UMLS CUI-1
- C1300072
Beschrijving
Tumor stage, Neoplasm Metastasis, maximum, Preoperative
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [1,4]
- C0445204
Beschrijving
Tumor stage, Neoplasm Metastasis, maximum, Postoperative Period
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [1,4]
- C0032790
Beschrijving
Tumor stage, Lesion, Postoperative Period
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0032790
Beschrijving
Tumor stage, Postoperative Period, Malignant Neoplasm, Measurable
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0006826
- UMLS CUI [1,4]
- C1513040
Beschrijving
Tumor stage, Postoperative Period, Malignant Neoplasm, Evaluation method
Datatype
text
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0006826
- UMLS CUI [1,4]
- C2911685
Beschrijving
Tumor stage, Postoperative Period, Malignant Neoplasm, Assessment Date
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0006826
- UMLS CUI [1,4]
- C2985720
Beschrijving
Tumor markers
Alias
- UMLS CUI-1
- C0041365
Beschrijving
Tumor Markers
Datatype
text
Alias
- UMLS CUI [1]
- C0041365
Beschrijving
Tumor Markers, Assessment Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C2985720
Beschrijving
Tumor Markers, Numerical value
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C1522609
Beschrijving
Tumor Markers, Unit of Measure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C1519795
Beschrijving
Tumor Markers, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C0947611
Beschrijving
Examination of the lower abdomen
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0230166
Beschrijving
Physical Examination, Pelvis, Finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
- UMLS CUI [1,3]
- C0243095
Beschrijving
Physical Examination, Pelvis, Finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
- UMLS CUI [1,3]
- C0243095
Beschrijving
Physical Examination, Pelvis, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
- UMLS CUI [1,3]
- C0011008
Beschrijving
Physical Examination, Vagina, Finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0042232
- UMLS CUI [1,3]
- C0243095
Beschrijving
Physical Examination, Vagina, Finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0042232
- UMLS CUI [1,3]
- C0243095
Beschrijving
Physical Examination, Vagina, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0042232
- UMLS CUI [1,3]
- C0011008
Beschrijving
Physical Examination, Rectum, Findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0034896
- UMLS CUI [1,3]
- C0243095
Beschrijving
Physical Examination, Rectum, Findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0034896
- UMLS CUI [1,3]
- C0243095
Beschrijving
Physical Examination, Rectum, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0034896
- UMLS CUI [1,3]
- C0011008
Beschrijving
Computed tomography
Alias
- UMLS CUI-1
- C0040405
Beschrijving
X-Ray Computed Tomography, Finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0243095
Beschrijving
X-Ray Computed Tomography, Finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0243095
Beschrijving
X-Ray Computed Tomography, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0011008
Beschrijving
X-ray
Alias
- UMLS CUI-1
- C1306645
Beschrijving
Plain x-ray, Finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C1306645
- UMLS CUI [1,2]
- C0243095
Beschrijving
Plain x-ray, Finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C1306645
- UMLS CUI [1,2]
- C0243095
Beschrijving
Plain x-ray, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C1306645
- UMLS CUI [1,2]
- C0011008
Beschrijving
ECG
Alias
- UMLS CUI-1
- C1623258
Beschrijving
Electrocardiography, Finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0243095
Beschrijving
Electrocardiography, Finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0243095
Beschrijving
Electrocardiography, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0011008
Beschrijving
Quality-of-life questionnaire
Alias
- UMLS CUI-1
- C0034394
- UMLS CUI-2
- C0034380
Beschrijving
Questionnaires, Quality of life, Compliance behavior
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1321605
Beschrijving
Questionnaires, Quality of life, Compliance behavior, Reason and justification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1321605
- UMLS CUI [1,4]
- C0566251
Beschrijving
Questionnaires, Quality of life, Supportive assistance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1521721
Beschrijving
Questionnaires, Quality of life, Supportive assistance, Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1521721
- UMLS CUI [1,4]
- C0027365
Beschrijving
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])