ID
41482
Beschrijving
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
Trefwoorden
Versies (1)
- 24-10-20 24-10-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 oktober 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Serious Adverse Event (SAE)
- StudyEvent: ODM
Beschrijving
Did the patient experience any serious adverse events during the study?
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C2347804
Beschrijving
SECTION 1 Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Other race - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C3845569
Beschrijving
Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Weight unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Beschrijving
Height
Datatype
float
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Height unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Beschrijving
SECTION 2 Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Sequential number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Diagnosis only (if known) OR Serious signs/symptoms (list one per line)
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschrijving
(0000-2359)
Datatype
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Beschrijving
Maximum intensity of SAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beschrijving
Outcome of SAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1]
- C2985918
- UMLS CUI [2]
- C1148348
Beschrijving
Action taken with study treatment because of SAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschrijving
Did the patient withdraw from study as a result of this SAE?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0877248
Beschrijving
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beschrijving
Does the AE meet the definition of serious? Only Option 1 can be chosen as Answer.
Datatype
integer
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
SECTION 3 Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C3641099
- UMLS CUI-2
- C1519255
Beschrijving
Disease under study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beschrijving
Treatment failure
Datatype
boolean
Alias
- UMLS CUI [1]
- C0162643
Beschrijving
Withdrawal of investigational product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Beschrijving
Concomitant disorder
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
Concomitant disorder - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1521902
Beschrijving
Concomitant medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Concomitant medication - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1521902
Beschrijving
Activity related to study participation, procedures
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0199171
Beschrijving
Activity related to study participation, procedures - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C0199171
- UMLS CUI [2,2]
- C1521902
Beschrijving
Other cause of SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
Beschrijving
Other cause of SAE - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschrijving
SECTION 4 Seriousness
Alias
- UMLS CUI-1
- C1710056
Beschrijving
If Yes, fill the following Question
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Beschrijving
(Send autopsy report when available.)
Datatype
text
Alias
- UMLS CUI [1]
- C1705232
- UMLS CUI [2]
- C0004398
Beschrijving
Life threatening AE
Datatype
boolean
Alias
- UMLS CUI [1]
- C1517874
Beschrijving
Hospitalization required or prolonged
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348993
Beschrijving
Disabling AE
Datatype
boolean
Alias
- UMLS CUI [1]
- C3830477
Beschrijving
AE seriousness due to congenital anomaly
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschrijving
Other SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other SAE - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beschrijving
SECTION 5 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1519255
Beschrijving
Sequential number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Medical history, allergies, surgeries relevant to SAE
Datatype
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
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschrijving
Disease present during SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C1519255
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0009488
Beschrijving
SECTION 6 Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
- UMLS CUI-4
- C2347946
Beschrijving
Risk factors relevant to SAE (social history, family history, smoking, alcohol, diet, drug abuse, occupational hazard)
Datatype
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
Beschrijving
SECTION 7 Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1522508
Beschrijving
Investigational product
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3173309
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beschrijving
SECTION 8 Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beschrijving
Sequential number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
(Trade Name Preferred)
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschrijving
Concomitant medication dose
Datatype
float
Alias
- UMLS CUI [1]
- C2826811
Beschrijving
Concomitant medication dose unit
Datatype
text
Alias
- UMLS CUI [1]
- C2826646
Beschrijving
Concomitant medication dose frequency
Datatype
text
Alias
- UMLS CUI [1]
- C2826654
Beschrijving
Concomitant medication route of administration
Datatype
text
Alias
- UMLS CUI [1]
- C2826730
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Concomitant medication started pre-study
Datatype
boolean
Alias
- UMLS CUI [1]
- C2981448
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Concomitant medication continued post-SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C0231290
- UMLS CUI [1,3]
- C1519255
Beschrijving
Concomintant medication indication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
SECTION 9 Narrative / Comments
Alias
- UMLS CUI-1
- C0947611
Beschrijving
SECTION 10 Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Beschrijving
Details of other evaluation of SAE, laboratory procedures
Datatype
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
Beschrijving
SECTION 11 Reporting Investigator
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Beschrijving
This Section should be filled in once for Sections 1-10 and eventually once for Additional or Follow-Up Information.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C1828479
Beschrijving
Investigator name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigator address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschrijving
Investigator signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Additional or Follow-Up Information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Beschrijving
Additional or Follow-Up Information
Datatype
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])