Informatie:
Fout:
ID
42002
Beschrijving
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853
Trefwoorden
Versies (2)
- 14-04-18 14-04-18 -
- 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 maart 2021
DOI
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Licentie
Creative Commons BY-NC 3.0
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Oral GW786034 treatment for ovarian cancer NCT00281632
Similar models
Screening
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Entry criteria
Item
Did the subject meet all the entry criteria? If No, check all boxes corresponding to violations of any inclusion/exclusion criteria. Do NOT enter the subject into the study if this failed any inclusion or exclusion criteria below.
boolean
C1516637 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Female (F)
CL Item
Male (M)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item
Child-bearing Potential: Check one
text
C1960468 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0015895 (UMLS CUI [1,2])
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
physical examination
Item
Has a physical examination been performed on the subject?
boolean
C0031809 (UMLS CUI [1])
Item
Examination Status
integer
C0031809 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
Normal (N)
(Comment:en)
CL Item
Abnormal (please specify) (A)
(Comment:en)
physical examination findings
Item
Abnormal examination findings
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
abnormal physical examination
Item
If abnormal record below
text
C0031809 (UMLS CUI [1,1])
C0459424 (UMLS CUI [1,2])
C0459424 (UMLS CUI [1,2])
Item
Primary Tumor type at Initial Diagnosis
text
C0449522 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,2])
CL Item
Fallopian Tube (42)
CL Item
Ovary (27)
CL Item
Primary Peritoneal (43)
CL Item
Other, specify (OT)
other primary tumor
Item
Specify other
text
C0449522 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0677930 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Date of initial diagnosis
Item
Date of initial diagnosis
date
C2316983 (UMLS CUI [1])
Item
Stage at initial diagnosis
text
C0474935 (UMLS CUI [1,1])
C4071762 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,2])
CL Item
I (1)
CL Item
II (2)
CL Item
IIIa (3A)
CL Item
IIIb (3B)
CL Item
IIIc (3C)
CL Item
IVa (4A)
CL Item
IVb (4B)
CL Item
IVc (4C)
Item
Histology at Initial Diagnosis
text
C0019638 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C3172269 (UMLS CUI [1,2])
CL Item
Malignant serous tumours (2)
CL Item
Malignant mucinous tumours (3)
CL Item
Malignant endometrioid tumours (4)
CL Item
Clear cell (13)
CL Item
Mixed epithelial cell (14)
CL Item
Undifferentiated adenocarcinoma (15)
CL Item
Unknown (U)
CL Item
Other, specify! (OT)
Histology other
Item
specify other histology
text
C0019638 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item
Histological Grade at Initial Diagnosis
text
C0919553 (UMLS CUI [1])
CL Item
Grade cannot be assessed (0)
CL Item
Well differentiated (1)
CL Item
Moderately differentiated (2)
CL Item
Poorly differentiated (3)
CL Item
Undifferentiated (4)
Date of recurrence
Item
Date of last recurrence
date
C3173322 (UMLS CUI [1])
CL Item
I (1)
CL Item
II (2)
CL Item
IIIa (3A)
CL Item
IIIb (3B)
CL Item
IIIc (3C)
CL Item
IVa (4A)
CL Item
IVb (4B)
CL Item
IVc (4C)
CL Item
Primary tumor cannot be assessed. (TX)
(Comment:en)
CL Item
No primary tumor is seen. (T0)
(Comment:en)
CL Item
(Stage I). Ovarian cancer (carcinoma) is limited to one or both ovaries. (T1)
(Comment:en)
CL Item
(Stage IA). Tumor is limited to one ovary. The ovarian capsule is intact and there is no tumor on the surface of the ovary. There are no cancer cells in the body fluid (peritoneal fluid) around the ovary. (T1a)
(Comment:en)
CL Item
(Stage IB). Tumor is limited to both ovaries. The ovarian capsule is intact and there is no tumor on the surface of the ovaries. There are no cancer cells in the body fluid (peritoneal fluid) around the ovaries. (T1b)
(Comment:en)
CL Item
(Stage IC). Tumor is limited to one or both ovaries AND the ovarian capsule is ruptured orthere is tumor on the surface of the ovaries or there are cancer cells in the body fluid (peritoneal fluid) around the ovaries. (T1c)
(Comment:en)
CL Item
(Stage II). Tumor involves one or both ovaries and extends into the pelvis or has implanted into the uterus. (T2)
(Comment:en)
CL Item
(Stage IIA). Tumor has extended or implanted into the uterus or fallopian tube but there are no cancer cells in the body fluid (peritoneal fluid) around the ovaries. (T2a)
(Comment:en)
CL Item
(Stage IIB). Tumor has extended or implanted into other pelvic tissues but there are no cancer cells in the body fluid (peritoneal fluid) around the ovaries. (T2b)
(Comment:en)
CL Item
(Stage IIC). Tumor has extended or implanted into other pelvic tissues (T23 or T2b) AND there are cancer cells in the body fluid (peritoneal fluid) around the ovaries. (T2c)
CL Item
(Stage III). Tumor involves one or both ovaries and there are cancer cells in body fluid outside the pelvis (peritoneal metastasis) identified in a sample of fluid under the microscope. (T3)
(Comment:en)
CL Item
(Stage IIIA). Cancer cells are identified microscopically in body fluid outside the pelvis (peritoneal metastasis) or on abdominal peritoneal surfaces. (T3a)
(Comment:en)
CL Item
(Stage IIIB). Tumor involves one or both ovaries and implants on abdominal peritoneal surfaces measure 2 cm (0.8 in.) or less in size. (T3b)
(Comment:en)
CL Item
(Stage IIIC) and Any T, N1M0 (Stage IIIC). Tumor implants on abdominal peritoneal surfaces measure 2 cm (0.8 in.) in size and cancer involves lymph nodes in the abdominal area. (T3c)
(Comment:en)
CL Item
Lymph nodes near the primary tumor cannot be evaluated. (NX)
CL Item
Cancer has not spread to lymph nodes nearthe primary tumor. (N0)
CL Item
Cancer has spread to lymph nodes near the primary tumor. (N1)
CL Item
Distant metastasis cannot be assessed. (MX)
CL Item
No distant metastasis is found. (M0)
CL Item
Metastasis to another part of the body has occurred. (M1)
Item
Lines of Therapy Completed at Screening
text
C1514463 (UMLS CUI [1])
CL Item
1 Line (1)
CL Item
Unknown (U)
Item
Response to Most Recent Prior Therapy
text
C0332152 (UMLS CUI [1,1])
C0871261 (UMLS CUI [1,2])
C0871261 (UMLS CUI [1,2])
CL Item
Platinum - refractory (6)
CL Item
Platinum - resistant (7)
CL Item
Platinum sensitive relapsed (8)
Item
Relapsed or Refractory Disease
text
C0205269 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0277556 (UMLS CUI [2])
CL Item
Relapsed < 6 months (5)
CL Item
Relapsed 6-12 months (6)
CL Item
Relapsed >12 months (7)
CL Item
Relapsed (time period unknown) (8)
CL Item
Refractory (2)
metastatic disease
Item
Metastatic Disease at Screening
boolean
C0027627 (UMLS CUI [1])
Date Metastatic Disease First Diagnosed
Item
Date Metastatic Disease First Diagnosed
date
C0011008 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
CL Item
Abdomen/abdominal wall (Abdomen/abdominal wall)
CL Item
Adrenals (Adrenals)
CL Item
Blood (Blood)
CL Item
Bladder (Bladder)
CL Item
Bone (Bone)
CL Item
Bone marrow (Bone marrow)
CL Item
Breast (Breast)
CL Item
Cervix (Cervix)
CL Item
Chest wall (Chest wall)
CL Item
CNS (CNS)
CL Item
Colon (Colon)
CL Item
Esophagus/oesophagus (Esophagus/oesophagus)
CL Item
Head and neck (Head and neck)
CL Item
Head (Head)
CL Item
Kidney (Kidney)
CL Item
Liver (Liver)
CL Item
Lung (Lung)
CL Item
Lymph nodes (Lymph nodes)
CL Item
Oral cavity (Oral cavity)
CL Item
Ovary (Ovary)
CL Item
Pancreas (Pancreas)
CL Item
Peritoneum (Peritoneum)
CL Item
Pleura (Pleura)
CL Item
Rectum (Rectum)
CL Item
Skin (Skin)
CL Item
Small intestine (Small intestine)
CL Item
Spleen (Spleen)
CL Item
Stomach (Stomach)
CL Item
Thyroid (Thyroid)
CL Item
Other, specify (Other, specify)
CL Item
Yes (Y)
(Comment:en)
CL Item
No (N)
(Comment:en)
CL Item
Not Assessed (NA)
(Comment:en)
Item Group
Local Laboratory [Previous CA-125 Values] - Multiple Assessment
C1254595 (UMLS CUI-1)
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Address
text
C1301826 (UMLS CUI [1,1])
C1882331 (UMLS CUI [1,2])
C1882331 (UMLS CUI [1,2])
GSK Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
CA 125
Item
float
C0201549 (UMLS CUI [1])
Item Group
Residual toxicities related to previous therapy for cancer
C0920425 (UMLS CUI-1)
C0013221 (UMLS CUI-2)
C0013221 (UMLS CUI-2)
residual toxicity
Item
Does the subject have any residual toxicities related to previous therapy for cancer?
boolean
C0920425 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,2])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item Group
Cancer related current medical conditions
C3899485 (UMLS CUI-1)
Cancer related current medical conditions
Item
Does the subject have any cancer related current medical conditions
boolean
C3899485 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item Group
non-cancer related medical conditions
C0262926 (UMLS CUI-1)
C1518422 (UMLS CUI-2)
C0006826 (UMLS CUI-3)
C0332281 (UMLS CUI-4)
C1518422 (UMLS CUI-2)
C0006826 (UMLS CUI-3)
C0332281 (UMLS CUI-4)
non-cancer related current medical conditions
Item
Does the subject have any non-cancer related current medical conditions
boolean
C3899485 (UMLS CUI [1,1])
C3640974 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C3640974 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item Group
Prior Anti-Cancer Therapy
C0920425 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C1514463 (UMLS CUI-2)
chemotherapy, hormonal therapy, immunotherapy, biologic therapy
Item
Has the subject received prior chemotherapy, hormonal, immunotherapy and/or biologic therapy for the cancer under study?
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0279025 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
Radiotherapy
Item
Has the subject received prior radiotherapy for the cancer under study?
boolean
C1522449 (UMLS CUI [1])
Item Group
Prior Anti-Cancer therapy: chemotherapy, hormonal, immunotherapy and/or biologic therapy for the cancer under study?
C0920425 (UMLS CUI-1)
C0205373 (UMLS CUI-2)
C0205373 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Regimen Sequence
Item
Regimen Sequence
integer
C19464 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C49153 (NCI Thesaurus ObjectClass-2)
C25694 (NCI Thesaurus Property)
C2348184 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C25463 (NCI Thesaurus ValueDomain)
C49153 (NCI Thesaurus ObjectClass-2)
C25694 (NCI Thesaurus Property)
C2348184 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Item
Therapy Type
text
C0087111 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2])
CL Item
Chemotherapy (cytotoxics, non-cytotoxics) (C)
CL Item
Hormone Therapy (H)
CL Item
Immunotherapy (I)
CL Item
Biological Therapy (antibodys, cytokines) (B)
Total number of cycles
Item
Number of Cycles/Doses
integer
C2045831 (UMLS CUI [1])
CL Item
Cycles (1)
CL Item
Doses (2)
Total Dose
Item
Cumulative Dose
float
C2986497 (UMLS CUI [1])
dose units
Item
Dose Units
text
C1519795 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
CL Item
Neoadjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or Metastatic (3)
CL Item
Local/Regional (4)
CL Item
Prophylactic (5)
CL Item
Radiosensitizer (6)
CL Item
Induction (10)
CL Item
Consolidation (11)
CL Item
Maintenance (12)
CL Item
Not Applicable (X)
Therapy start date
Item
Start Date
date
C3173309 (UMLS CUI [1])
Therapy stop date
Item
Stop Date
date
C1531784 (UMLS CUI [1])
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
CL Item
Unknown (U)
Overall Response Duration
Item
Duration of Response
integer
C0237585 (UMLS CUI [1])
Item Group
Prior anti-cancer therapy - radiotherapy
C1522449 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
C0920425 (UMLS CUI-2)
Anatomic Site
Item
Site
text
C1515974 (UMLS CUI [1])
Total Dose
Item
Cumulative Dose
float
C2986497 (UMLS CUI [1])
CL Item
Gy (1)
CL Item
cGy (2)
CL Item
x100 RAD (3)
CL Item
Neoadjuvant (1)
(Comment:en)
CL Item
Adjuvant (2)
(Comment:en)
CL Item
Advanced or Metastatic (3)
(Comment:en)
CL Item
Local/Regional (4)
(Comment:en)
CL Item
Prophylactic (5)
(Comment:en)
CL Item
Palliative (7)
(Comment:en)
CL Item
Curative (9)
(Comment:en)
CL Item
Other (OT)
(Comment:en)
Therapy start date
Item
Start Date
date
C3173309 (UMLS CUI [1])
Therapy stop date
Item
Stop Date
date
C1531784 (UMLS CUI [1])
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
CL Item
Unknown (U)
Overall Response Duration
Item
Duration of Response
integer
C0237585 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood pressure
Item
Blood pressure, systolic
integer
C0005823 (UMLS CUI [1])
Blood pressure
Item
Blood pressure, diastolic
integer
C0005823 (UMLS CUI [1])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Time
Item
Start time of ECG
time
C0040223 (UMLS CUI [1])
Date
Item
Start Date of ECG
date
C0011008 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Item Group
12-lead ECG Abnormalities
C0522055 (UMLS CUI-1)
C0430456 (UMLS CUI-2)
C0430456 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Rhythm Abnormalities
Item
Other abnormal rhythm, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities: P Wave Morphology
integer
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Code List
Record clinically significant abnormalities: P Wave Morphology
CL Item
Left atrial abnormality (P mltrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology, enter comment (6)
P Wave Morphology Abnormalities
Item
Other morphology, enter comment
text
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Conduction Abnormalities
Item
Other conduction, enter comment
text
C0232219 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities: Myocardial Infarction
integer
C3854475 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Code List
Record clinically significant abnormalities: Myocardial Infarction
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, non Q-wave (7)
CL Item
Other myocardial infarction, enter comment (8)
Myocardial Infarction ECG
Item
Other myocardial infarction, enter comment
text
C3854475 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Depolarisation/Repolarisation Abnormalities
Item
Other depolarisation/repolarisation, enter comment
text
C0948857 (UMLS CUI [1])
12-lead ECG Abnormalities
Item
Other abnormalities
text
C0522055 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities: Rhythm
integer
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (1)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (2)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (3)
CL Item
Sinus pause (4)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (5)
CL Item
Ectopic supraventricular beats (6)
CL Item
Ectopic supraventricular rhythm (7)
CL Item
Wandering atrial pacemaker (8)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (9)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (10)
CL Item
Atrial flutter (11)
CL Item
Atrial fibrillation (12)
CL Item
unctional rhythm (heart rate ≤100 beats/min) (13)
CL Item
Junctional rhythm (14)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (15)
CL Item
Ectopic ventricular beats (16)
CL Item
Ventricular couplets (17)
CL Item
Bigeminy (18)
CL Item
Trigeminy (19)
CL Item
Electrical alternans (20)
CL Item
R on T phenomenon (21)
CL Item
Ventricular fibrillation (22)
CL Item
Idioventricular rhythm (heart rate < 100 beats/min) (23)
CL Item
Sustained ventricular tachycardia (24)
CL Item
Non-sustained ventricular tachycardia (25)
CL Item
Ventricular tachycardia (26)
CL Item
Monomorphic ventricular tachycardia (27)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (28)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (29)
CL Item
Artificial pacemaker (30)
CL Item
Other abnormal rhythm (31)
Item
Record clinically significant abnormalities: Conduction
integer
C0232219 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
First degree AV block (PR interval > 200 msec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30°) (6)
CL Item
Right axis deviation (QRS axis more positive than +110°) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Incomplete left bundle branch block (9)
CL Item
Right bundle branch block (10)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (11)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (12)
CL Item
Left bundle branch block (13)
CL Item
Bifascicular block (14)
CL Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (15)
CL Item
QT/QTc prolongation ≥ 500 msec (17)
CL Item
AV dissociation (18)
CL Item
Other conduction (19)
Item
Record clinically significant abnormalities: Depolarisation/Repolarisation (QRS-T)
integer
C0948857 (UMLS CUI [1])
Code List
Record clinically significant abnormalities: Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST elevation-pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/inversion (13)
CL Item
Other depolarisation/repolarisation (14)
Item Group
Local Laboratory - Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date Sample taken Haematology
Item
Date Sample taken Haematology
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Haematocrit (HCT)
Item
Haematocrit (HCT)
float
C0018935 (UMLS CUI [1])
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
float
C0518015 (UMLS CUI [1])
Platelet count (absolute)
Item
Platelet count (absolute)
float
C0032181 (UMLS CUI [1])
White blood cell count (WBC) (Absolute)
Item
White blood cell count (WBC) (Absolute)
float
C0023508 (UMLS CUI [1])
Neutrophil count (absolute)
Item
Neutrophil count (absolute)
float
C0948762 (UMLS CUI [1])
Lymphocyte count (absolute)
Item
Lymphocyte count (absolute)
float
C3544087 (UMLS CUI [1])
PTT
Item
Activated Partial Thromboplastin Time (PTT)
float
C0030605 (UMLS CUI [1])
INR
Item
International Normalized Ratio
float
C0525032 (UMLS CUI [1])
Prothrombin time
Item
Prothrombin time
float
C0033707 (UMLS CUI [1])
Item Group
Local Laboratory - Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken clinical chemistry
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
BUN
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
Glucose (fasting)
Item
Glucose (fasting)
float
C0583513 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Lipase
Item
Serum lipase
float
C0373670 (UMLS CUI [1])
Amylase
Item
Serum Amylase
float
C0201883 (UMLS CUI [1])
T4
Item
T4 (only if TSH abnormal)
float
C0202231 (UMLS CUI [1])
TSH
Item
TSH
float
C0202230 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
UPC ratio
Item
UPC ratio
float
C1524119 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
C0033684 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Date of first CA-125 sample
Item
Date of first CA-125 sample
date
C0011008 (UMLS CUI [1,1])
C0201549 (UMLS CUI [1,2])
C0201549 (UMLS CUI [1,2])
Date of second CA-125 sample
Item
Date of second CA-125 sample
date
C0011008 (UMLS CUI [1,1])
C0201549 (UMLS CUI [1,2])
C0201549 (UMLS CUI [1,2])