ID
41482
Beschreibung
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
Stichworte
Versionen (1)
- 24.10.20 24.10.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. Oktober 2020
DOI
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Lizenz
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
Beschreibung
Did the patient experience any serious adverse events during the study?
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C2347804
Beschreibung
SECTION 1 Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Race
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Other race - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C3845569
Beschreibung
Weight
Datentyp
float
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Weight unit
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Beschreibung
Height
Datentyp
float
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Height unit
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Beschreibung
SECTION 2 Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Sequential number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Diagnosis only (if known) OR Serious signs/symptoms (list one per line)
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschreibung
(0000-2359)
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Beschreibung
Maximum intensity of SAE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beschreibung
Outcome of SAE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1]
- C2985918
- UMLS CUI [2]
- C1148348
Beschreibung
Action taken with study treatment because of SAE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschreibung
Did the patient withdraw from study as a result of this SAE?
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0877248
Beschreibung
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beschreibung
Does the AE meet the definition of serious? Only Option 1 can be chosen as Answer.
Datentyp
integer
Alias
- UMLS CUI [1]
- C1710056
Beschreibung
SECTION 3 Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C3641099
- UMLS CUI-2
- C1519255
Beschreibung
Disease under study
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beschreibung
Treatment failure
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0162643
Beschreibung
Withdrawal of investigational product
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Beschreibung
Concomitant disorder
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
Concomitant disorder - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1521902
Beschreibung
Concomitant medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Concomitant medication - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1521902
Beschreibung
Activity related to study participation, procedures
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0199171
Beschreibung
Activity related to study participation, procedures - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C0199171
- UMLS CUI [2,2]
- C1521902
Beschreibung
Other cause of SAE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
Beschreibung
Other cause of SAE - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschreibung
SECTION 4 Seriousness
Alias
- UMLS CUI-1
- C1710056
Beschreibung
If Yes, fill the following Question
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Beschreibung
(Send autopsy report when available.)
Datentyp
text
Alias
- UMLS CUI [1]
- C1705232
- UMLS CUI [2]
- C0004398
Beschreibung
Life threatening AE
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1517874
Beschreibung
Hospitalization required or prolonged
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348993
Beschreibung
Disabling AE
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3830477
Beschreibung
AE seriousness due to congenital anomaly
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschreibung
Other SAE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
Beschreibung
Other SAE - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beschreibung
SECTION 5 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1519255
Beschreibung
Sequential number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Medical history, allergies, surgeries relevant to SAE
Datentyp
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
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschreibung
Disease present during SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C1519255
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0009488
Beschreibung
SECTION 6 Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
- UMLS CUI-4
- C2347946
Beschreibung
Risk factors relevant to SAE (social history, family history, smoking, alcohol, diet, drug abuse, occupational hazard)
Datentyp
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
Beschreibung
SECTION 7 Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1522508
Beschreibung
Investigational product
Datentyp
text
Alias
- UMLS CUI [1]
- C0304229
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3173309
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beschreibung
SECTION 8 Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beschreibung
Sequential number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
(Trade Name Preferred)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschreibung
Concomitant medication dose
Datentyp
float
Alias
- UMLS CUI [1]
- C2826811
Beschreibung
Concomitant medication dose unit
Datentyp
text
Alias
- UMLS CUI [1]
- C2826646
Beschreibung
Concomitant medication dose frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C2826654
Beschreibung
Concomitant medication route of administration
Datentyp
text
Alias
- UMLS CUI [1]
- C2826730
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Concomitant medication started pre-study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2981448
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Concomitant medication continued post-SAE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C0231290
- UMLS CUI [1,3]
- C1519255
Beschreibung
Concomintant medication indication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
SECTION 9 Narrative / Comments
Alias
- UMLS CUI-1
- C0947611
Beschreibung
SECTION 10 Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Beschreibung
Details of other evaluation of SAE, laboratory procedures
Datentyp
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
Beschreibung
SECTION 11 Reporting Investigator
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Beschreibung
This Section should be filled in once for Sections 1-10 and eventually once for Additional or Follow-Up Information.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C1828479
Beschreibung
Investigator name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigator address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschreibung
Investigator signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Additional or Follow-Up Information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Beschreibung
Additional or Follow-Up Information
Datentyp
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
Ähnliche Modelle
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])