ID
37618
Beskrivning
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
Nyckelord
Versioner (2)
- 2019-08-11 2019-08-11 -
- 2021-09-17 2021-09-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 augusti 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612
Baseline
- StudyEvent: ODM
Beskrivning
Date
Alias
- UMLS CUI-1
- C2985720
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Patient date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Body Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Body Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Body Surface Area
Datatyp
float
Måttenheter
- m2
Alias
- UMLS CUI [1]
- C0005902
Beskrivning
Menopausal status
Alias
- UMLS CUI-1
- C1513126
Beskrivning
Medical History
Alias
- UMLS CUI-1
- C0262926
Beskrivning
body system or organ function
Datatyp
text
Alias
- UMLS CUI [1]
- C0678852
Beskrivning
Medical History
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262926
Beskrivning
Medical History, Current, Previous
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0521116
- UMLS CUI [1,3]
- C0205156
Beskrivning
Medical History, Specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1521902
Beskrivning
Symptoms at study start
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C2348558
Beskrivning
Symptoms, Study Start Date
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
Beskrivning
Symptoms, Study Start Date
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
Beskrivning
Symptoms, Study Start Date, Symptom Intensity
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
- UMLS CUI [1,3]
- C0518690
Beskrivning
Symptoms, Study Start Date, Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348558
- UMLS CUI [1,3]
- C0947611
Beskrivning
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Concomitant Agent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Concomitant Agent, Medication name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beskrivning
Concomitant Medication Daily Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C2826638
Beskrivning
Concomitant Agent, Drug Administration Routes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Beskrivning
Concomitant Agent, Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3146298
Beskrivning
Concomitant Medication Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
Concomitant Medication End Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Concomitant Medication Ongoing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Assessment of performance status
Alias
- UMLS CUI-1
- C1520224
Beskrivning
Tumor history
Alias
- UMLS CUI-1
- C0260455
Beskrivning
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0677886
Beskrivning
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer, FIGO stage
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0677886
- UMLS CUI [1,3]
- C0450454
Beskrivning
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer, FIGO stage
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0677886
- UMLS CUI [1,3]
- C0450454
Beskrivning
Personal history of malignant neoplasm, unspecified, Peritoneal Cancer Index
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C4049621
Beskrivning
Personal history of malignant neoplasm, unspecified, Ascites
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0003962
Beskrivning
Personal history of malignant neoplasm, unspecified, Secondary malignant neoplasm of lymph node, Palpable
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0686619
- UMLS CUI [1,3]
- C0522499
Beskrivning
Personal history of malignant neoplasm, unspecified, Secondary malignant neoplasm of lymph node, Histological finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0260455
- UMLS CUI [1,2]
- C0686619
- UMLS CUI [1,3]
- C0449575
Beskrivning
Histology
Alias
- UMLS CUI-1
- C0029925
- UMLS CUI-2
- C0019638
Beskrivning
Ovarian Carcinoma, Histology
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0019638
Beskrivning
Ovarian Carcinoma, Histology
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0019638
Beskrivning
Ovarian Carcinoma, Histology, Histopathologic Grade
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0019638
- UMLS CUI [1,3]
- C0919553
Beskrivning
Surgery of Ovarian Carcinoma
Alias
- UMLS CUI-1
- C0029925
- UMLS CUI-2
- C0543467
Beskrivning
Ovarian Carcinoma, Operative Surgical Procedures, Date in time
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0011008
Beskrivning
Ovarian Carcinoma, Operative Surgical Procedures, Surgical approach
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0449446
Beskrivning
Ovarian Carcinoma, Operative Surgical Procedures, Anatomic structure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0700276
Beskrivning
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Left
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0205091
Beskrivning
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Previously
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0205156
Beskrivning
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0011008
Beskrivning
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0029925
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0849355
- UMLS CUI [1,4]
- C0566251
Beskrivning
Tumor metrics
Alias
- UMLS CUI-1
- C1300072
Beskrivning
Tumor stage, Neoplasm Metastasis, maximum, Preoperative
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [1,4]
- C0445204
Beskrivning
Tumor stage, Neoplasm Metastasis, maximum, Postoperative Period
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [1,4]
- C0032790
Beskrivning
Tumor stage, Lesion, Postoperative Period
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0032790
Beskrivning
Tumor stage, Postoperative Period, Malignant Neoplasm, Measurable
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0006826
- UMLS CUI [1,4]
- C1513040
Beskrivning
Tumor stage, Postoperative Period, Malignant Neoplasm, Evaluation method
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0006826
- UMLS CUI [1,4]
- C2911685
Beskrivning
Tumor stage, Postoperative Period, Malignant Neoplasm, Assessment Date
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0006826
- UMLS CUI [1,4]
- C2985720
Beskrivning
Tumor markers
Alias
- UMLS CUI-1
- C0041365
Beskrivning
Tumor Markers
Datatyp
text
Alias
- UMLS CUI [1]
- C0041365
Beskrivning
Tumor Markers, Assessment Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C2985720
Beskrivning
Tumor Markers, Numerical value
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C1522609
Beskrivning
Tumor Markers, Unit of Measure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C1519795
Beskrivning
Tumor Markers, Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C0947611
Beskrivning
Examination of the lower abdomen
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0230166
Beskrivning
Physical Examination, Pelvis, Finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
- UMLS CUI [1,3]
- C0243095
Beskrivning
Physical Examination, Pelvis, Finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
- UMLS CUI [1,3]
- C0243095
Beskrivning
Physical Examination, Pelvis, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
- UMLS CUI [1,3]
- C0011008
Beskrivning
Physical Examination, Vagina, Finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0042232
- UMLS CUI [1,3]
- C0243095
Beskrivning
Physical Examination, Vagina, Finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0042232
- UMLS CUI [1,3]
- C0243095
Beskrivning
Physical Examination, Vagina, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0042232
- UMLS CUI [1,3]
- C0011008
Beskrivning
Physical Examination, Rectum, Findings
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0034896
- UMLS CUI [1,3]
- C0243095
Beskrivning
Physical Examination, Rectum, Findings
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0034896
- UMLS CUI [1,3]
- C0243095
Beskrivning
Physical Examination, Rectum, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0034896
- UMLS CUI [1,3]
- C0011008
Beskrivning
Computed tomography
Alias
- UMLS CUI-1
- C0040405
Beskrivning
X-Ray Computed Tomography, Finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0243095
Beskrivning
X-Ray Computed Tomography, Finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0243095
Beskrivning
X-Ray Computed Tomography, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0011008
Beskrivning
X-ray
Alias
- UMLS CUI-1
- C1306645
Beskrivning
Plain x-ray, Finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1306645
- UMLS CUI [1,2]
- C0243095
Beskrivning
Plain x-ray, Finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1306645
- UMLS CUI [1,2]
- C0243095
Beskrivning
Plain x-ray, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1306645
- UMLS CUI [1,2]
- C0011008
Beskrivning
ECG
Alias
- UMLS CUI-1
- C1623258
Beskrivning
Electrocardiography, Finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0243095
Beskrivning
Electrocardiography, Finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0243095
Beskrivning
Electrocardiography, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0011008
Beskrivning
Quality-of-life questionnaire
Alias
- UMLS CUI-1
- C0034394
- UMLS CUI-2
- C0034380
Beskrivning
Questionnaires, Quality of life, Compliance behavior
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1321605
Beskrivning
Questionnaires, Quality of life, Compliance behavior, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1321605
- UMLS CUI [1,4]
- C0566251
Beskrivning
Questionnaires, Quality of life, Supportive assistance
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1521721
Beskrivning
Questionnaires, Quality of life, Supportive assistance, Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C1521721
- UMLS CUI [1,4]
- C0027365
Beskrivning
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])