ID
32008
Beskrivning
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial
Nyckelord
Versioner (4)
- 2018-09-22 2018-09-22 -
- 2018-09-27 2018-09-27 -
- 2018-10-08 2018-10-08 -
- 2018-10-11 2018-10-11 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 oktober 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
AED Plasma Concentration - Baseline Week 4 and 6, Laboratory Comments - Baseline Week 4 and 6 and Study Continuation Record - Baseline Study Week 8
Beskrivning
Laboratory finding - Week 4
Alias
- UMLS CUI-1
- C0587081
Beskrivning
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Beskrivning
Laboratory results that are of potential or actual clinical significance and unexpected - Week 4
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C2826293
- UMLS CUI-3
- C4055646
Beskrivning
AED plasma concentration - Week 4
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0683150
Beskrivning
Laboratory finding - Week 6
Alias
- UMLS CUI-1
- C0587081
Beskrivning
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Beskrivning
Laboratory results that are of potential or actual clinical significance and unexpected - Week 6
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C2826293
- UMLS CUI-3
- C4055646
Beskrivning
AED plasma concentration - Week 6
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0683150
Beskrivning
Study Continuitation Record - Date of assessment
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-3
- C2985720
Beskrivning
Study Continuitation Record - Inclusion and Exclusion Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-3
- C1512693
- UMLS CUI-5
- C0680251
Beskrivning
Study Continuitation Record - Baseline Seizure Inclusion Criterion
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1512693
- UMLS CUI-3
- C0036572
- UMLS CUI-4
- C1442488
Beskrivning
This answer must be YES. If No, the patient will be withdrawn from the study.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0036572
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C1272706
- UMLS CUI [1,4]
- C0347984
- UMLS CUI [2,1]
- C1299590
- UMLS CUI [2,2]
- C1272706
- UMLS CUI [2,3]
- C1442488
- UMLS CUI [2,4]
- C0347984
Beskrivning
Study Continuitation Record - Eligibility Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1516637
Beskrivning
Menarche; Visit; Last; Since
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0025274
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Beskrivning
If the answer is No, the patient will be withdrawn from the study.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Beskrivning
If the answer is No, the patient will be withdrawn from the study.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [2,1]
- C0700589
- UMLS CUI [2,2]
- C0699733
- UMLS CUI [3,1]
- C0700589
- UMLS CUI [3,2]
- C3843422
Beskrivning
In addition, all other appropriate person (e.g. parent or legal guardian, if not already obtained as part of the previous requirement, investigator and witness) must also sign this statement. If the answer is No, the patient will be withdrawn from the study.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710187
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0032961
- UMLS CUI [1,4]
- C0870186
Similar models
AED Plasma Concentration - Baseline Week 4 and 6, Laboratory Comments - Baseline Week 4 and 6 and Study Continuation Record - Baseline Study Week 8
C0237753 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
C2826293 (UMLS CUI-2)
C4055646 (UMLS CUI-3)
C0549193 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2,1])
C0549193 (UMLS CUI [2,2])
C0683150 (UMLS CUI-2)
C0683150 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
C2826293 (UMLS CUI-2)
C4055646 (UMLS CUI-3)
C0549193 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2,1])
C0549193 (UMLS CUI [2,2])
C0683150 (UMLS CUI-2)
C0683150 (UMLS CUI [1,2])
C2985720 (UMLS CUI-3)
C1512693 (UMLS CUI-3)
C0680251 (UMLS CUI-5)
C0680251 (UMLS CUI [1,2])
C1512693 (UMLS CUI-2)
C0036572 (UMLS CUI-3)
C1442488 (UMLS CUI-4)
C0750480 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C1299590 (UMLS CUI [2,1])
C1272706 (UMLS CUI [2,2])
C1442488 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C1516637 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
C0032961 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0013227 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0699733 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C3843422 (UMLS CUI [3,2])
C1519316 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0870186 (UMLS CUI [1,4])