ID
41482
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00039858
Nyckelord
Versioner (1)
- 2020-10-24 2020-10-24 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
24 oktober 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Serious Adverse Event (SAE)
- StudyEvent: ODM
Beskrivning
Did the patient experience any serious adverse events during the study?
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C2347804
Beskrivning
SECTION 1 Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Sex
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Race
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Other race - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C3845569
Beskrivning
Weight
Datatyp
float
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Weight unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Beskrivning
Height
Datatyp
float
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Height unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Beskrivning
SECTION 2 Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Sequential number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Diagnosis only (if known) OR Serious signs/symptoms (list one per line)
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beskrivning
(0000-2359)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Beskrivning
Maximum intensity of SAE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beskrivning
Outcome of SAE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1]
- C2985918
- UMLS CUI [2]
- C1148348
Beskrivning
Action taken with study treatment because of SAE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
Did the patient withdraw from study as a result of this SAE?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0877248
Beskrivning
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beskrivning
Does the AE meet the definition of serious? Only Option 1 can be chosen as Answer.
Datatyp
integer
Alias
- UMLS CUI [1]
- C1710056
Beskrivning
SECTION 3 Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C3641099
- UMLS CUI-2
- C1519255
Beskrivning
Disease under study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beskrivning
Treatment failure
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0162643
Beskrivning
Withdrawal of investigational product
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Beskrivning
Concomitant disorder
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beskrivning
Concomitant disorder - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1521902
Beskrivning
Concomitant medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Concomitant medication - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1521902
Beskrivning
Activity related to study participation, procedures
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0199171
Beskrivning
Activity related to study participation, procedures - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C0199171
- UMLS CUI [2,2]
- C1521902
Beskrivning
Other cause of SAE
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
Beskrivning
Other cause of SAE - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beskrivning
SECTION 4 Seriousness
Alias
- UMLS CUI-1
- C1710056
Beskrivning
If Yes, fill the following Question
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Beskrivning
(Send autopsy report when available.)
Datatyp
text
Alias
- UMLS CUI [1]
- C1705232
- UMLS CUI [2]
- C0004398
Beskrivning
Life threatening AE
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1517874
Beskrivning
Hospitalization required or prolonged
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348993
Beskrivning
Disabling AE
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3830477
Beskrivning
AE seriousness due to congenital anomaly
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826727
Beskrivning
Other SAE
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other SAE - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beskrivning
SECTION 5 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1519255
Beskrivning
Sequential number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Medical history, allergies, surgeries relevant to SAE
Datatyp
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
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beskrivning
Disease present during SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C1519255
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0009488
Beskrivning
SECTION 6 Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
- UMLS CUI-4
- C2347946
Beskrivning
Risk factors relevant to SAE (social history, family history, smoking, alcohol, diet, drug abuse, occupational hazard)
Datatyp
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
Beskrivning
SECTION 7 Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1522508
Beskrivning
Investigational product
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3173309
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beskrivning
SECTION 8 Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beskrivning
Sequential number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
(Trade Name Preferred)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beskrivning
Concomitant medication dose
Datatyp
float
Alias
- UMLS CUI [1]
- C2826811
Beskrivning
Concomitant medication dose unit
Datatyp
text
Alias
- UMLS CUI [1]
- C2826646
Beskrivning
Concomitant medication dose frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C2826654
Beskrivning
Concomitant medication route of administration
Datatyp
text
Alias
- UMLS CUI [1]
- C2826730
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
Concomitant medication started pre-study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2981448
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Concomitant medication continued post-SAE
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C0231290
- UMLS CUI [1,3]
- C1519255
Beskrivning
Concomintant medication indication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826696
Beskrivning
SECTION 9 Narrative / Comments
Alias
- UMLS CUI-1
- C0947611
Beskrivning
SECTION 10 Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Beskrivning
Details of other evaluation of SAE, laboratory procedures
Datatyp
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
Beskrivning
SECTION 11 Reporting Investigator
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Beskrivning
This Section should be filled in once for Sections 1-10 and eventually once for Additional or Follow-Up Information.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C1828479
Beskrivning
Investigator name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Investigator address
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beskrivning
Investigator signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Additional or Follow-Up Information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Beskrivning
Additional or Follow-Up Information
Datatyp
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])