ID

37618

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)
  1. 11-08-19 11-08-19 -
  2. 17-09-21 17-09-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 augustus 2019

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

Engels

Baseline

1 Formulieren  
  1. StudyEvent: ODM
    1. Baseline
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Centre number
Beschrijving

Study Coordinating Center, Identification number

Datatype

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Centre name
Beschrijving

Study Coordinating Center

Datatype

text

Alias
UMLS CUI [1]
C2825181
Patient Number
Beschrijving

Patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Date
Beschrijving

Date

Alias
UMLS CUI-1
C2985720
Date
Beschrijving

Assessment Date

Datatype

date

Alias
UMLS CUI [1]
C2985720
Demography
Beschrijving

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschrijving

Patient date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Height
Beschrijving

Body Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Body Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Beschrijving

Body Surface Area

Datatype

float

Maateenheden
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Menopausal status
Beschrijving

Menopausal status

Alias
UMLS CUI-1
C1513126
Menopausal status
Beschrijving

Menopausal Status

Datatype

text

Alias
UMLS CUI [1]
C1513126
If childbearing potential, Contraceptives
Beschrijving

Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
Please specify
Beschrijving

Contraceptive methods

Datatype

text

Alias
UMLS CUI [1]
C0700589
Medical History
Beschrijving

Medical History

Alias
UMLS CUI-1
C0262926
Body System
Beschrijving

body system or organ function

Datatype

text

Alias
UMLS CUI [1]
C0678852
Medical History
Beschrijving

Medical History

Datatype

boolean

Alias
UMLS CUI [1]
C0262926
Current or Previous
Beschrijving

Medical History, Current, Previous

Datatype

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C0205156
If "Yes", please specify
Beschrijving

Medical History, Specify

Datatype

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1521902
Symptoms at study start
Beschrijving

Symptoms at study start

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C2348558
Does the patient show any symptoms at study start?
Beschrijving

Symptoms, Study Start Date

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2348558
Symptoms
Beschrijving

Symptoms, Study Start Date

Datatype

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2348558
Max. grade according to CTC (please mark)
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
Comment
Beschrijving

Symptoms, Study Start Date, Comment

Datatype

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2348558
UMLS CUI [1,3]
C0947611
Concomitant Medication
Beschrijving

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Did the patient take any medications during the last 30 days?
Beschrijving

Concomitant Agent

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Medication (trade name)
Beschrijving

Concomitant Agent, Medication name

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Daily dose
Beschrijving

Concomitant Medication Daily Dose

Datatype

text

Alias
UMLS CUI [1]
C2826638
Mode of application
Beschrijving

Concomitant Agent, Drug Administration Routes

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Indication
Beschrijving

Concomitant Agent, Indication

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Start date
Beschrijving

Concomitant Medication Start Date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Stop date
Beschrijving

Concomitant Medication End Date

Datatype

date

Alias
UMLS CUI [1]
C2826744
Mark if ongoing
Beschrijving

Concomitant Medication Ongoing

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Assessment of performance status
Beschrijving

Assessment of performance status

Alias
UMLS CUI-1
C1520224
Assess the patient's performance status according to ECOG grading
Beschrijving

ECOG performance status

Datatype

integer

Maateenheden
  • grade
Alias
UMLS CUI [1]
C1520224
grade
Tumor history
Beschrijving

Tumor history

Alias
UMLS CUI-1
C0260455
Primary diagnosis: Histologically confirmed epithelial ovarian carcinoma (no non-epithelial or mixed epithelial/non-epithelial tumors or tumors with low malignant potential, i.e. borderline tumors)
Beschrijving

Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0260455
UMLS CUI [1,2]
C0677886
FIGO stage
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
In case of FIGO IV, please specify
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
Peritoneal carcinosis
Beschrijving

Personal history of malignant neoplasm, unspecified, Peritoneal Cancer Index

Datatype

boolean

Alias
UMLS CUI [1,1]
C0260455
UMLS CUI [1,2]
C4049621
Ascites > 500 ml (intraoperative)
Beschrijving

Personal history of malignant neoplasm, unspecified, Ascites

Datatype

boolean

Alias
UMLS CUI [1,1]
C0260455
UMLS CUI [1,2]
C0003962
Lymph node metastasis, palpatory (intraoperative)
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
Lymph node metastasis, histological
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
Histology
Beschrijving

Histology

Alias
UMLS CUI-1
C0029925
UMLS CUI-2
C0019638
Please mark, if applicable
Beschrijving

Ovarian Carcinoma, Histology

Datatype

text

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C0019638
Please specify
Beschrijving

Ovarian Carcinoma, Histology

Datatype

text

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C0019638
Grading
Beschrijving

Ovarian Carcinoma, Histology, Histopathologic Grade

Datatype

text

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C0019638
UMLS CUI [1,3]
C0919553
Surgery of Ovarian Carcinoma
Beschrijving

Surgery of Ovarian Carcinoma

Alias
UMLS CUI-1
C0029925
UMLS CUI-2
C0543467
Date of surgery
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
Surgical approach
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
Please mark as applicable
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
Removed or Left?
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
Previously removed
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
Date
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
Reason
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
Tumor metrics
Beschrijving

Tumor metrics

Alias
UMLS CUI-1
C1300072
Intra-operative tumor metrics - Maximum pre-operative metastasis (not ovarian tumor)
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
mm
Intra-operative tumor metrics - Maximum post-operative metastasis
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
mm
Intra-operative tumor metrics - Number of post-operative lesions
Beschrijving

Tumor stage, Lesion, Postoperative Period

Datatype

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0032790
Post-operative tumor metrics - Measurable/evaluable tumor after surgery? (not intra-operative assessment)
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
Post-operative tumor metrics - Which method was applied? Please mark as applicable
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
Post-operative tumor metrics - When was the assessment made?
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
Tumor markers
Beschrijving

Tumor markers

Alias
UMLS CUI-1
C0041365
Tumor marker
Beschrijving

Tumor Markers

Datatype

text

Alias
UMLS CUI [1]
C0041365
Date
Beschrijving

Tumor Markers, Assessment Date

Datatype

date

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C2985720
Value
Beschrijving

Tumor Markers, Numerical value

Datatype

integer

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C1522609
Unit
Beschrijving

Tumor Markers, Unit of Measure

Datatype

text

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C1519795
if applicable, please comment
Beschrijving

Tumor Markers, Comment

Datatype

text

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C0947611
Examination of the lower abdomen
Beschrijving

Examination of the lower abdomen

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0230166
Finding of pelvis
Beschrijving

Physical Examination, Pelvis, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C0243095
Please specify
Beschrijving

Physical Examination, Pelvis, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C0243095
Date of examination
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
Findings of vagina
Beschrijving

Physical Examination, Vagina, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0042232
UMLS CUI [1,3]
C0243095
Please specify
Beschrijving

Physical Examination, Vagina, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0042232
UMLS CUI [1,3]
C0243095
Date of examination
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
Findings of rectum
Beschrijving

Physical Examination, Rectum, Findings

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0034896
UMLS CUI [1,3]
C0243095
Please specify
Beschrijving

Physical Examination, Rectum, Findings

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0034896
UMLS CUI [1,3]
C0243095
Date of examination
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
Computed tomography
Beschrijving

Computed tomography

Alias
UMLS CUI-1
C0040405
Findings in CT
Beschrijving

X-Ray Computed Tomography, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0243095
Please specify
Beschrijving

X-Ray Computed Tomography, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0243095
Date of examination
Beschrijving

X-Ray Computed Tomography, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0011008
X-ray
Beschrijving

X-ray

Alias
UMLS CUI-1
C1306645
Findings in x-ray
Beschrijving

Plain x-ray, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C1306645
UMLS CUI [1,2]
C0243095
Please specify
Beschrijving

Plain x-ray, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C1306645
UMLS CUI [1,2]
C0243095
Date of examination
Beschrijving

Plain x-ray, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C1306645
UMLS CUI [1,2]
C0011008
ECG
Beschrijving

ECG

Alias
UMLS CUI-1
C1623258
Findings in ECG
Beschrijving

Electrocardiography, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0243095
Please specify
Beschrijving

Electrocardiography, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0243095
Date of examination
Beschrijving

Electrocardiography, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0011008
Quality-of-life questionnaire
Beschrijving

Quality-of-life questionnaire

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0034380
Has the patient completed the questionnaire?
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
If No, Reason
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
Did the patient need help for the completion of the questionnaire?
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
Name of the supporting person
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
Receptors
Beschrijving

Receptors

Alias
UMLS CUI-1
C0597357
ER
Beschrijving

Estrogen Receptors

Datatype

text

Alias
UMLS CUI [1]
C0034804
PR
Beschrijving

Status of progesterone receptors of neoplasm

Datatype

text

Alias
UMLS CUI [1]
C2919590
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Similar models

Baseline

1 Formulieren
  1. StudyEvent: ODM
    1. Baseline
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Centre number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Study Coordinating Center
Item
Centre name
text
C2825181 (UMLS CUI [1])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Item Group
Date
C2985720 (UMLS CUI-1)
Assessment Date
Item
Date
date
C2985720 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Surface Area
Item
Body surface area
float
C0005902 (UMLS CUI [1])
Item Group
Menopausal status
C1513126 (UMLS CUI-1)
Item
Menopausal status
text
C1513126 (UMLS CUI [1])
Menopausal Status
Code List
Menopausal status
CL Item
Sterile (1)
CL Item
Postmenopausal (2)
CL Item
Childbearing potential (3)
Contraceptive methods
Item
If childbearing potential, Contraceptives
boolean
C0700589 (UMLS CUI [1])
Contraceptive methods
Item
Please specify
text
C0700589 (UMLS CUI [1])
Item Group
Medical History
C0262926 (UMLS CUI-1)
Item
Body System
text
C0678852 (UMLS CUI [1])
body system or organ function
Code List
Body System
CL Item
Ears, nose, throat (1)
CL Item
Eyes (2)
CL Item
Respiratory (3)
CL Item
Cardio-/vascular (4)
CL Item
Gastrointestinal (5)
CL Item
Hepatobiliary (6)
CL Item
Urinary tract (7)
CL Item
Reproductive system (8)
CL Item
Nervous system (9)
CL Item
Blood & lymphatic system (10)
CL Item
Endocrine / metabolic (11)
CL Item
Musculo /skeletal system (12)
CL Item
Skin & appendages  (13)
CL Item
Psychiatric  (14)
CL Item
Others (e.g. allergies) (15)
Medical History
Item
Medical History
boolean
C0262926 (UMLS CUI [1])
Item
Current or Previous
text
C0262926 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Medical History, Current, Previous
Code List
Current or Previous
CL Item
Current (1)
CL Item
Previous (2)
Medical History, Specify
Item
If "Yes", please specify
text
C0262926 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Symptoms at study start
C1457887 (UMLS CUI-1)
C2348558 (UMLS CUI-2)
Symptoms, Study Start Date
Item
Does the patient show any symptoms at study start?
boolean
C1457887 (UMLS CUI [1,1])
C2348558 (UMLS CUI [1,2])
Item
Symptoms
text
C1457887 (UMLS CUI [1,1])
C2348558 (UMLS CUI [1,2])
Symptoms, Study Start Date
Code List
Symptoms
CL Item
Alopecia (1)
CL Item
Nausea (2)
CL Item
Vomiting (3)
CL Item
Constipation (4)
CL Item
Peripheral sensory neuropathy (5)
CL Item
Motoric neuropathy (6)
CL Item
Impaired hearing (7)
CL Item
Infections (8)
CL Item
Pain (9)
CL Item
Dyspnoea (10)
CL Item
Anaemia (Hb) (11)
CL Item
Other (please specify) (12)
Item
Max. grade according to CTC (please mark)
text
C1457887 (UMLS CUI [1,1])
C2348558 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Symptoms, Study Start Date
Code List
Max. grade according to CTC (please mark)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Item
Comment
text
C1457887 (UMLS CUI [1,1])
C2348558 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Symptoms, Study Start Date
Code List
Comment
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Agent
Item
Did the patient take any medications during the last 30 days?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent, Medication name
Item
Medication (trade name)
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medication Daily Dose
Item
Daily dose
text
C2826638 (UMLS CUI [1])
Concomitant Agent, Drug Administration Routes
Item
Mode of application
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Agent, Indication
Item
Indication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Concomitant Medication Start Date
Item
Start date
date
C2826734 (UMLS CUI [1])
Concomitant Medication End Date
Item
Stop date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Mark if ongoing
boolean
C2826666 (UMLS CUI [1])
Item Group
Assessment of performance status
C1520224 (UMLS CUI-1)
ECOG performance status
Item
Assess the patient's performance status according to ECOG grading
integer
C1520224 (UMLS CUI [1])
Item Group
Tumor history
C0260455 (UMLS CUI-1)
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer
Item
Primary diagnosis: Histologically confirmed epithelial ovarian carcinoma (no non-epithelial or mixed epithelial/non-epithelial tumors or tumors with low malignant potential, i.e. borderline tumors)
boolean
C0260455 (UMLS CUI [1,1])
C0677886 (UMLS CUI [1,2])
Item
FIGO stage
text
C0260455 (UMLS CUI [1,1])
C0677886 (UMLS CUI [1,2])
C0450454 (UMLS CUI [1,3])
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer, FIGO stage
Code List
FIGO stage
CL Item
IC (1)
CL Item
IIA (2)
CL Item
IIB (3)
CL Item
IIC (4)
CL Item
IIIA (5)
CL Item
IIIB (6)
CL Item
IIIC (7)
CL Item
IV (8)
Item
In case of FIGO IV, please specify
text
C0260455 (UMLS CUI [1,1])
C0677886 (UMLS CUI [1,2])
C0450454 (UMLS CUI [1,3])
Personal history of malignant neoplasm, unspecified, Epithelial ovarian cancer, FIGO stage
Code List
In case of FIGO IV, please specify
Personal history of malignant neoplasm, unspecified, Peritoneal Cancer Index
Item
Peritoneal carcinosis
boolean
C0260455 (UMLS CUI [1,1])
C4049621 (UMLS CUI [1,2])
Personal history of malignant neoplasm, unspecified, Ascites
Item
Ascites > 500 ml (intraoperative)
boolean
C0260455 (UMLS CUI [1,1])
C0003962 (UMLS CUI [1,2])
Item
Lymph node metastasis, palpatory (intraoperative)
text
C0260455 (UMLS CUI [1,1])
C0686619 (UMLS CUI [1,2])
C0522499 (UMLS CUI [1,3])
Personal history of malignant neoplasm, unspecified, Secondary malignant neoplasm of lymph node, Palpable
Code List
Lymph node metastasis, palpatory (intraoperative)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not determined (3)
Item
Lymph node metastasis, histological
text
C0260455 (UMLS CUI [1,1])
C0686619 (UMLS CUI [1,2])
C0449575 (UMLS CUI [1,3])
Personal history of malignant neoplasm, unspecified, Secondary malignant neoplasm of lymph node, Palpable
Code List
Lymph node metastasis, histological
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not determined (3)
Item Group
Histology
C0029925 (UMLS CUI-1)
C0019638 (UMLS CUI-2)
Item
Please mark, if applicable
text
C0029925 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
Ovarian Carcinoma, Histology
Code List
Please mark, if applicable
CL Item
serous/papillary (1)
CL Item
mucinous (2)
CL Item
undifferentiated (3)
CL Item
endometrioid (4)
CL Item
mixed type (5)
CL Item
other, please specify (6)
Ovarian Carcinoma, Histology
Item
Please specify
text
C0029925 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
Item
Grading
text
C0029925 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
C0919553 (UMLS CUI [1,3])
Ovarian Carcinoma, Histology, Histopathologic Grade
Code List
Grading
CL Item
G1 (1)
CL Item
G2 (2)
CL Item
G3 (3)
CL Item
unknown (Gx) (4)
Item Group
Surgery of Ovarian Carcinoma
C0029925 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
Ovarian Carcinoma, Operative Surgical Procedures, Date in time
Item
Date of surgery
text
C0029925 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Surgical approach
text
C0029925 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0449446 (UMLS CUI [1,3])
Ovarian Carcinoma, Operative Surgical Procedures, Surgical approach
Code List
Surgical approach
CL Item
Sagittal (1)
CL Item
Transverse (2)
CL Item
Pelviscopic (3)
Item
Please mark as applicable
text
C0029925 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0700276 (UMLS CUI [1,3])
Ovarian Carcinoma, Operative Surgical Procedures, Surgical approach
Code List
Please mark as applicable
CL Item
Uterus (1)
CL Item
Adnexa, right (2)
CL Item
Adnexa, left (3)
CL Item
Greater omentum (4)
CL Item
Douglas' peritoneum (5)
CL Item
Partial intestinal resection (6)
CL Item
Para-aortic lymph nodes (7)
CL Item
Pelvic lymph nodes (8)
Item
Removed or Left?
text
C0029925 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0849355 (UMLS CUI [1,3])
C0205091 (UMLS CUI [1,4])
Ovarian Carcinoma, Operative Surgical Procedures, Surgical approach
Code List
Removed or Left?
CL Item
Removed (1)
CL Item
Left (2)
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Previously
Item
Previously removed
boolean
C0029925 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0849355 (UMLS CUI [1,3])
C0205156 (UMLS CUI [1,4])
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Date in time
Item
Date
date
C0029925 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0849355 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Ovarian Carcinoma, Operative Surgical Procedures, Removed, Reason and justification
Item
Reason
text
C0029925 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0849355 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Item Group
Tumor metrics
C1300072 (UMLS CUI-1)
Tumor stage, Neoplasm Metastasis, maximum, Preoperative
Item
Intra-operative tumor metrics - Maximum pre-operative metastasis (not ovarian tumor)
integer
C1300072 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0445204 (UMLS CUI [1,4])
Tumor stage, Neoplasm Metastasis, maximum, Postoperative Period
Item
Intra-operative tumor metrics - Maximum post-operative metastasis
integer
C1300072 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0032790 (UMLS CUI [1,4])
Tumor stage, Lesion, Postoperative Period
Item
Intra-operative tumor metrics - Number of post-operative lesions
integer
C1300072 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
Tumor stage, Postoperative Period, Malignant Neoplasm, Measurable
Item
Post-operative tumor metrics - Measurable/evaluable tumor after surgery? (not intra-operative assessment)
boolean
C1300072 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1513040 (UMLS CUI [1,4])
Item
Post-operative tumor metrics - Which method was applied? Please mark as applicable
text
C1300072 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,4])
Tumor stage, Postoperative Period, Malignant Neoplasm, Evaluation method
Code List
Post-operative tumor metrics - Which method was applied? Please mark as applicable
CL Item
Palpation (1)
CL Item
X-ray (2)
CL Item
Sonography (3)
CL Item
NMR (4)
CL Item
CT (5)
CL Item
Other (6)
Tumor stage, Postoperative Period, Malignant Neoplasm, Assessment Date
Item
Post-operative tumor metrics - When was the assessment made?
boolean
C1300072 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2985720 (UMLS CUI [1,4])
Item Group
Tumor markers
C0041365 (UMLS CUI-1)
Item
Tumor marker
text
C0041365 (UMLS CUI [1])
Tumor Markers
Code List
Tumor marker
CL Item
CA 125 - pre OP (1)
CL Item
CA 125 - post OP (2)
Tumor Markers, Assessment Date
Item
Date
date
C0041365 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Tumor Markers, Numerical value
Item
Value
integer
C0041365 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
Item
Unit
text
C0041365 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Tumor Markers, Unit of Measure
Code List
Unit
CL Item
U/ml (1)
CL Item
U/ml (2)
Item
if applicable, please comment
text
C0041365 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Tumor Markers, Unit of Measure
Code List
if applicable, please comment
Item Group
Examination of the lower abdomen
C0031809 (UMLS CUI-1)
C0230166 (UMLS CUI-2)
Item
Finding of pelvis
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Physical Examination, Pelvis, Finding
Code List
Finding of pelvis
CL Item
normal (1)
CL Item
abnormal (2)
Item
Please specify
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Physical Examination, Pelvis, Finding
Code List
Please specify
Physical Examination, Pelvis, Date in time
Item
Date of examination
date
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Findings of vagina
text
C0031809 (UMLS CUI [1,1])
C0042232 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Physical Examination, Vagina, Finding
Code List
Findings of vagina
CL Item
normal (1)
CL Item
abnormal (2)
Item
Please specify
text
C0031809 (UMLS CUI [1,1])
C0042232 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Physical Examination, Vagina, Finding
Code List
Please specify
Physical Examination, Vagina, Date in time
Item
Date of examination
date
C0031809 (UMLS CUI [1,1])
C0042232 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Findings of rectum
text
C0031809 (UMLS CUI [1,1])
C0034896 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Physical Examination, Rectum, Findings
Code List
Findings of rectum
CL Item
normal (1)
CL Item
abnormal (2)
Physical Examination, Rectum, Findings
Item
Please specify
text
C0031809 (UMLS CUI [1,1])
C0034896 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Physical Examination, Rectum, Date in time
Item
Date of examination
date
C0031809 (UMLS CUI [1,1])
C0034896 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Computed tomography
C0040405 (UMLS CUI-1)
Item
Findings in CT
text
C0040405 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
X-Ray Computed Tomography, Finding
Code List
Findings in CT
CL Item
normal (1)
CL Item
abnormal (2)
Item
Please specify
text
C0040405 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
X-Ray Computed Tomography, Finding
Code List
Please specify
X-Ray Computed Tomography, Date in time
Item
Date of examination
date
C0040405 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
X-ray
C1306645 (UMLS CUI-1)
Item
Findings in x-ray
text
C1306645 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Plain x-ray, Finding
Code List
Findings in x-ray
CL Item
normal (1)
CL Item
abnormal (2)
Plain x-ray, Finding
Item
Please specify
text
C1306645 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Plain x-ray, Date in time
Item
Date of examination
date
C1306645 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Findings in ECG
text
C1623258 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Electrocardiography, Finding
Code List
Findings in ECG
CL Item
normal (1)
CL Item
abnormal (2)
Item
Please specify
text
C1623258 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Electrocardiography, Finding
Code List
Please specify
Electrocardiography, Date in time
Item
Date of examination
date
C1623258 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Quality-of-life questionnaire
C0034394 (UMLS CUI-1)
C0034380 (UMLS CUI-2)
Questionnaires, Quality of life, Compliance behavior
Item
Has the patient completed the questionnaire?
boolean
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Questionnaires, Quality of life, Compliance behavior, Reason and justification
Item
If No, Reason
text
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Questionnaires, Quality of life, Supportive assistance
Item
Did the patient need help for the completion of the questionnaire?
boolean
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C1521721 (UMLS CUI [1,3])
Questionnaires, Quality of life, Supportive assistance, Name
Item
Name of the supporting person
text
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C1521721 (UMLS CUI [1,3])
C0027365 (UMLS CUI [1,4])
Item Group
Receptors
C0597357 (UMLS CUI-1)
Item
ER
text
C0034804 (UMLS CUI [1])
Estrogen Receptors
Code List
ER
CL Item
positive (1)
CL Item
negative (2)
CL Item
unknown (3)
Item
PR
text
C2919590 (UMLS CUI [1])
Estrogen Receptors
Code List
PR
CL Item
positive (1)
CL Item
negative (2)
CL Item
unknown (3)
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