Informações:
Falhas:
ID
32159
Descrição
Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous
Palavras-chave
Versões (1)
- 22/10/2018 22/10/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
22 de outubro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619
Similar models
Visit 01
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Details of Operation
C0543467 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
C1522508 (UMLS CUI-2)
Item
Type of surgery
text
C0543467 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
CL Item
Gastrointestinal (Gastrointestinal)
CL Item
Gynecological (Gynecological)
CL Item
Urological (Urological)
CL Item
Other,specify (Other,specify)
Cancer surgery
Item
Cancer surgery
boolean
C0920424 (UMLS CUI [1])
Induction of general anesthesia; Date in time; Time
Item
Date and time of anesthesia induction
datetime
C0473960 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Time of incision
Item
Time of incision
time
C2116297 (UMLS CUI [1])
Time of incision; closure by suture
Item
Time of incision closure
time
C2116297 (UMLS CUI [1,1])
C0009068 (UMLS CUI [1,2])
C0009068 (UMLS CUI [1,2])
CL Item
General (General)
CL Item
Spinal/Epidural (Spinal/Epidural)
Peripheral Venous Catheter; Central venous catheter, device
Item
Was any i.v. or central venous line used?
boolean
C2985513 (UMLS CUI [1])
C1145640 (UMLS CUI [2])
C1145640 (UMLS CUI [2])
Cell saver, Equipment
Item
Was cell saver equipment used?
boolean
C1441512 (UMLS CUI [1,1])
C0014672 (UMLS CUI [1,2])
C0014672 (UMLS CUI [1,2])
date time
Item
Date and time of removal of Indewelling Intrathecal or Epidural Catheter
datetime
C3524354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C3524353 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C3524353 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item
Post-operative - Prior to first post-operative injection
text
C0474523 (UMLS CUI [1,1])
C2112579 (UMLS CUI [1,2])
C2112579 (UMLS CUI [1,2])
Code List
Post-operative - Prior to first post-operative injection
CL Item
Not done (Not done)
CL Item
Same laboratory as recorded before (Same laboratory as recorded before)
Item
Laboratory Name/City
text
C0474523 (UMLS CUI [1,1])
C1882331 (UMLS CUI [1,2])
C1882331 (UMLS CUI [1,2])
CL Item
Not done (Not done)
CL Item
Same laboratory as recorded before (Same laboratory as recorded before)
Hematology finding; Sampling; Date in time; Time
Item
Date and Time of Sampling
datetime
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Test
text
C0474523 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
CL Item
Platelet (Platelet)
CL Item
Hemoglobin (Hemoglobin)
Hematology finding; Numerical Value
Item
Value
float
C0474523 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,2])
CL Item
10^9/L (10^9/L)
CL Item
g/dL (g/dL)
Hematology finding; Unit, other
Item
If other unit, specify
text
C0474523 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0439148 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
major abdominal surgery
Item
Undergoing major abdominal surgery (any surgery between the diaphragm and the pelvic floor) lasting longer than 45 min (duration from induction of anesthesia to closure)
boolean
C0455612 (UMLS CUI [1])
Age
Item
Over 40 years
boolean
C0001779 (UMLS CUI [1])
Bleeding active, Clinical significance
Item
Active, clinically significant bleeding
boolean
C0741554 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
Bleeding tendency, Blood coagulation disorder
Item
Documented congenital or acquired bleeding tendency/disorder(s)
boolean
C1458140 (UMLS CUI [1,1])
C0005779 (UMLS CUI [1,2])
C0005779 (UMLS CUI [1,2])
Gastrointestinal Diseases
Item
Active ulcerative gastrointestinal disease unless it's the reason for the present surgery
boolean
C0017178 (UMLS CUI [1])
Intracranial Hemorrhages, Recent; Operation on brain, Recent; Spinal Cord, Operative Surgical Procedures, Recent; Ophthalmologic Surgical Procedures, Recent
Item
Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation) brain, spinal, orophthalmologic surgery
boolean
C0151699 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0195775 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0037925 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0038901 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C0332185 (UMLS CUI [1,2])
C0195775 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0037925 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0038901 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
Catheters, Spinal, Intrathecal
Item
Indwelling intrathecal or epidural catheters for more than 2 hours after surgical closure
boolean
C2584606 (UMLS CUI [1])
Catheter, Spinal, Intrathecal; Function procedure
Item
Patient with indwelling intrathecal or epidural catheter at the time of randomization, or patients who had a traumatic puncture or unusual difficulty in applying the catheter (e.g., more than two attempts or a bloody tap)
boolean
C2584606 (UMLS CUI [1])
C0034117 (UMLS CUI [2])
C0034117 (UMLS CUI [2])
Cerebral metastasis
Item
Known cerebral metastases
boolean
C0555278 (UMLS CUI [1])
Hemostatic function
Item
Patient in whom hemostasis has not been established 6 hours after surgical closure
boolean
C0019116 (UMLS CUI [1])
Thrombocytopenia
Item
Current thrombocytopenia (<100.000/mm3)
boolean
C0040034 (UMLS CUI [1])
Bacterial Endocarditis
Item
Bacterial endocarditis
boolean
C0014121 (UMLS CUI [1])
Creatinine measurement
Item
Creatinine level above 2.0 mg/dl (180 μmol/L) in a well-hydrated patient
boolean
C0201976 (UMLS CUI [1])
Contrast Media; Hypersensitivity
Item
Documented hypersensitivity to contrast media
boolean
C0009924 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
Contrast Media; Medical Contraindication
Item
Use of any contraindicated drug that could not be combined with the injection of contrast medium
boolean
C0009924 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,2])
Peripheral vascular disease; Peripheral ischemia
Item
Patient with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings
boolean
C0085096 (UMLS CUI [1,1])
C0235490 (UMLS CUI [1,2])
C0235490 (UMLS CUI [1,2])
major abdominal surgery
Item
Undergoing major abdominal surgery (any surgery between the diaphragm and the pelvic floor) lasting longer than 45 min (duration from induction of anesthesia to closure)
boolean
C0455612 (UMLS CUI [1])
Age
Item
Over 40 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Patient who has signed the informed consent
boolean
C0021430 (UMLS CUI [1])
Bleeding active, Clinical significance
Item
Active, clinically significant bleeding
boolean
C0741554 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
Bleeding tendency, Blood coagulation disorder
Item
Documented congenital or acquired bleeding tendency/disorder(s)
boolean
C1458140 (UMLS CUI [1,1])
C0005779 (UMLS CUI [1,2])
C0005779 (UMLS CUI [1,2])
Gastrointestinal Diseases
Item
Active ulcerative gastrointestinal disease unless it's the reason for the present surgery
boolean
C0017178 (UMLS CUI [1])
Intracranial Hemorrhages, Recent; Operation on brain, Recent; Spinal Cord, Operative Surgical Procedures, Recent; Ophthalmologic Surgical Procedures, Recent
Item
Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation) brain, spinal, orophthalmologic surgery
boolean
C0151699 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0195775 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0037925 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0038901 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C0332185 (UMLS CUI [1,2])
C0195775 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0037925 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0038901 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
Catheters, Spinal, Intrathecal
Item
Indwelling intrathecal or epidural catheters for more than 2 hours after surgical closure
boolean
C2584606 (UMLS CUI [1])
Catheter, Spinal, Intrathecal; Function procedure
Item
Patient with indwelling intrathecal or epidural catheter at the time of randomization, or patients who had a traumatic puncture or unusual difficulty in applying the catheter (e.g., more than two attempts or a bloody tap)
boolean
C2584606 (UMLS CUI [1])
C0034117 (UMLS CUI [2])
C0034117 (UMLS CUI [2])
Cerebral metastasis
Item
Known cerebral metastases
boolean
C0555278 (UMLS CUI [1])
Hemostatic function
Item
Patient in whom hemostasis has not been established 6 hours after surgical closure
boolean
C0019116 (UMLS CUI [1])
Thrombocytopenia
Item
Current thrombocytopenia (<100.000/mm3)
boolean
C0040034 (UMLS CUI [1])
Bacterial Endocarditis
Item
Bacterial endocarditis
boolean
C0014121 (UMLS CUI [1])
Creatinine measurement
Item
Creatinine level above 2.0 mg/dl (180 μmol/L) in a well-hydrated patient
boolean
C0201976 (UMLS CUI [1])
Contrast Media; Hypersensitivity
Item
Documented hypersensitivity to contrast media
boolean
C0009924 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
Pregnancy; Breast Feeding
Item
Known pregnancy and/or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Contrast Media; Medical Contraindication
Item
Use of any contraindicated drug that could not be combined with the injection of contrast medium
boolean
C0009924 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,2])
Peripheral vascular disease; Peripheral ischemia
Item
Patient with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings
boolean
C0085096 (UMLS CUI [1,1])
C0235490 (UMLS CUI [1,2])
C0235490 (UMLS CUI [1,2])
Mental Disorders
Item
Mental disorders that could interfere with study participation and/or failure to give written informed consent to take part in the study
boolean
C0004936 (UMLS CUI [1])
Life Expectancy
Item
Patient's life-expectancy < 6 months
boolean
C0023671 (UMLS CUI [1])
Deep Vein Thrombosis
Item
Clinical sign of DVT and/or history of recent DVT (i.e., within the previous 3 months)
boolean
C0149871 (UMLS CUI [1])
Study Subject Participation Status
Item
Participation in any other therapeutic drug study or a device study evaluating DVT prophylaxis within 90 days preceding inclusion
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status; Fondaparinux sodium
Item
Previous participation in a study of fondaparinux sodium
boolean
C2348568 (UMLS CUI [1,1])
C1098510 (UMLS CUI [1,2])
C1098510 (UMLS CUI [1,2])
Fondaparinux, Hypersensitivity
Item
Known hypersensitivity to fondaparinux sodium and its excipients
boolean
C1098510 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
Mental disorders, Addictive behavior
Item
Current addictive disorders that could interfere with study participation
boolean
C0004936 (UMLS CUI [1,1])
C0085281 (UMLS CUI [1,2])
C0085281 (UMLS CUI [1,2])
Use of anticoagulation; preoperative
Item
Administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin, fibrinolytic agents or drugs blocking GPIIb-IIIa platelet receptors two calendar days before surgery
boolean
C0449867 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,2])
Anticoagulation contraindicated; Use of anticoagulation, no, Discontinuation (procedure)
Item
Patients for whom anticoagulant therapy was contraindicated or who have, due to concomitant disease, an indication for oral anticoagulant or heparins (including LMWH) and who can not discontinue those treatments
boolean
C1531588 (UMLS CUI [1])
C0449867 (UMLS CUI [2,1])
C1298908 (UMLS CUI [2,2])
C0457454 (UMLS CUI [2,3])
C0449867 (UMLS CUI [2,1])
C1298908 (UMLS CUI [2,2])
C0457454 (UMLS CUI [2,3])
Contraception status
Item
Women of child-bearing potential: women not using an appropriate contraceptive method during the whole duration of study participation (oral contraceptive, intrauterine device, surgical sterilization, parenteral contraception)
boolean
C0420837 (UMLS CUI [1])
Body Weight
Item
Patient with body weight <50Kg
boolean
C0005910 (UMLS CUI [1])
Prophylactic treatment, Requirement; Pneumatic compression therapy, Requirement
Item
Patients, who in the opinion of the investigator, require a pharmacological prophylaxis in addition to intermittent pneumatic compression
boolean
C0199176 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1167944 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1514873 (UMLS CUI [1,2])
C1167944 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Item Group
Treatment Assignment
C0087111 (UMLS CUI-1)
C1516050 (UMLS CUI-2)
C1516050 (UMLS CUI-2)
Randomization; Date in time; Time
Item
Date and Time of randomization
datetime
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Clinical Trial Subject Unique Identifier
Item
Treatment Number
integer
C2348585 (UMLS CUI [1])
Pregnancy; Breast Feeding
Item
Known pregnancy and/or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Pregnancy; Breastfeeding, planned
Item
Known pregnancy and/or women who intend to breastfeed
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0006147 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Vascular Surgical Procedures
Item
Patients undergoing vascular surgery
boolean
C0042381 (UMLS CUI [1])
Item Group
Treatment Assignment
C0087111 (UMLS CUI-1)
C1516050 (UMLS CUI-2)
C1516050 (UMLS CUI-2)
Randomization; Date in time; Time
Item
Date and Time of randomization
datetime
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Clinical Trial Subject Unique Identifier
Item
Treatment Number
integer
C2348585 (UMLS CUI [1])