ID
41482
Description
Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 - See https://clinicaltrials.gov/ct2/show/NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. The Serious Adverse Event (SAE) Form has to be filled in each time when such Event occurs throughout the course of the Study.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Keywords
Versions (1)
- 10/24/20 10/24/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 24, 2020
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Serious Adverse Event (SAE)
- StudyEvent: ODM
Description
Did the patient experience any serious adverse events during the study?
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C2347804
Description
SECTION 1 Demography
Alias
- UMLS CUI-1
- C0011298
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Other race - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C3845569
Description
Weight
Data type
float
Alias
- UMLS CUI [1]
- C0005910
Description
Weight unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Description
Height
Data type
float
Alias
- UMLS CUI [1]
- C0005890
Description
Height unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Description
SECTION 2 Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Description
Sequential number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Diagnosis only (if known) OR Serious signs/symptoms (list one per line)
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Description
(0000-2359)
Data type
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Description
Maximum intensity of SAE
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Description
Outcome of SAE
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1]
- C2985918
- UMLS CUI [2]
- C1148348
Description
Action taken with study treatment because of SAE
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Did the patient withdraw from study as a result of this SAE?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0877248
Description
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Description
Does the AE meet the definition of serious? Only Option 1 can be chosen as Answer.
Data type
integer
Alias
- UMLS CUI [1]
- C1710056
Description
SECTION 3 Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C3641099
- UMLS CUI-2
- C1519255
Description
Disease under study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
Treatment failure
Data type
boolean
Alias
- UMLS CUI [1]
- C0162643
Description
Withdrawal of investigational product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Description
Concomitant disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
Concomitant disorder - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1521902
Description
Concomitant medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Concomitant medication - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1521902
Description
Activity related to study participation, procedures
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0199171
Description
Activity related to study participation, procedures - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C0199171
- UMLS CUI [2,2]
- C1521902
Description
Other cause of SAE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
Description
Other cause of SAE - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Description
SECTION 4 Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
If Yes, fill the following Question
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Description
(Send autopsy report when available.)
Data type
text
Alias
- UMLS CUI [1]
- C1705232
- UMLS CUI [2]
- C0004398
Description
Life threatening AE
Data type
boolean
Alias
- UMLS CUI [1]
- C1517874
Description
Hospitalization required or prolonged
Data type
boolean
Alias
- UMLS CUI [1]
- C2348993
Description
Disabling AE
Data type
boolean
Alias
- UMLS CUI [1]
- C3830477
Description
AE seriousness due to congenital anomaly
Data type
boolean
Alias
- UMLS CUI [1]
- C2826727
Description
Other SAE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
Description
Other SAE - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Description
SECTION 5 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1519255
Description
Sequential number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Medical history, allergies, surgeries relevant to SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C1519255
- UMLS CUI [3,1]
- C0543467
- UMLS CUI [3,2]
- C1519255
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Description
Disease present during SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C1519255
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0009488
Description
SECTION 6 Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
- UMLS CUI-4
- C2347946
Description
Risk factors relevant to SAE (social history, family history, smoking, alcohol, diet, drug abuse, occupational hazard)
Data type
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2347946
- UMLS CUI [2]
- C3714536
- UMLS CUI [3]
- C0241889
- UMLS CUI [4]
- C0543414
- UMLS CUI [5]
- C0001948
- UMLS CUI [6]
- C0012155
- UMLS CUI [7]
- C0013146
- UMLS CUI [8]
- C0337074
Description
SECTION 7 Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1522508
Description
Investigational product
Data type
text
Alias
- UMLS CUI [1]
- C0304229
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3173309
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Description
SECTION 8 Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Description
Sequential number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
(Trade Name Preferred)
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Description
Concomitant medication dose
Data type
float
Alias
- UMLS CUI [1]
- C2826811
Description
Concomitant medication dose unit
Data type
text
Alias
- UMLS CUI [1]
- C2826646
Description
Concomitant medication dose frequency
Data type
text
Alias
- UMLS CUI [1]
- C2826654
Description
Concomitant medication route of administration
Data type
text
Alias
- UMLS CUI [1]
- C2826730
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant medication started pre-study
Data type
boolean
Alias
- UMLS CUI [1]
- C2981448
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Concomitant medication continued post-SAE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C0231290
- UMLS CUI [1,3]
- C1519255
Description
Concomintant medication indication
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
SECTION 9 Narrative / Comments
Alias
- UMLS CUI-1
- C0947611
Description
SECTION 10 Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Description
Details of other evaluation of SAE, laboratory procedures
Data type
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1522508
- UMLS CUI [2]
- C0022885
Description
SECTION 11 Reporting Investigator
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Description
This Section should be filled in once for Sections 1-10 and eventually once for Additional or Follow-Up Information.
Data type
text
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C1828479
Description
Investigator name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator address
Data type
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Description
Investigator signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Additional or Follow-Up Information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Description
Additional or Follow-Up Information
Data type
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2,1]
- C1522577
- UMLS CUI [2,2]
- C1533716
- UMLS CUI [2,3]
- C1519255
Similar models
Serious Adverse Event (SAE)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0347984 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C3845569 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI-2)
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0199171 (UMLS CUI [2])
C1521902 (UMLS CUI [1,2])
C0199171 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0011065 (UMLS CUI [1,2])
C0004398 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1519255 (UMLS CUI [3,2])
C1519255 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0009488 (UMLS CUI [1,4])
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C2347946 (UMLS CUI-4)
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,4])
C3714536 (UMLS CUI [2])
C0241889 (UMLS CUI [3])
C0543414 (UMLS CUI [4])
C0001948 (UMLS CUI [5])
C0012155 (UMLS CUI [6])
C0013146 (UMLS CUI [7])
C0337074 (UMLS CUI [8])
C1522508 (UMLS CUI-2)
C3173309 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2360065 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,2])
C2981656 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
C1519255 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522508 (UMLS CUI [1,4])
C0022885 (UMLS CUI [2])
C1533716 (UMLS CUI-2)
C1828479 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])