ID
32008
Descripción
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
Palabras clave
Versiones (4)
- 22/9/18 22/9/18 -
- 27/9/18 27/9/18 -
- 8/10/18 8/10/18 -
- 11/10/18 11/10/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
11 de octubre de 2018
DOI
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Licencia
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
Descripción
Laboratory finding - Week 4
Alias
- UMLS CUI-1
- C0587081
Descripción
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Descripción
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
Descripción
Laboratory; Parameter Value
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Descripción
Comment | Laboratory; Parameter Value
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Descripción
AED plasma concentration - Week 4
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0683150
Descripción
Laboratory finding - Week 6
Alias
- UMLS CUI-1
- C0587081
Descripción
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Descripción
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
Descripción
Laboratory; Parameter Value
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Descripción
Comment | Laboratory; Parameter Value
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Descripción
AED plasma concentration - Week 6
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0683150
Descripción
Study Continuitation Record - Date of assessment
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-3
- C2985720
Descripción
Study Continuitation Record - Inclusion and Exclusion Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-3
- C1512693
- UMLS CUI-5
- C0680251
Descripción
Study Continuitation Record - Baseline Seizure Inclusion Criterion
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1512693
- UMLS CUI-3
- C0036572
- UMLS CUI-4
- C1442488
Descripción
This answer must be YES. If No, the patient will be withdrawn from the study.
Tipo de datos
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
Descripción
Study Continuitation Record - Eligibility Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1516637
Descripción
Menarche; Visit; Last; Since
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0025274
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Descripción
If the answer is No, the patient will be withdrawn from the study.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Descripción
If the answer is No, the patient will be withdrawn from the study.
Tipo de datos
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
Descripción
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.
Tipo de datos
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])