ID
32008
Description
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
Mots-clés
Versions (4)
- 22/09/2018 22/09/2018 -
- 27/09/2018 27/09/2018 -
- 08/10/2018 08/10/2018 -
- 11/10/2018 11/10/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
11 octobre 2018
DOI
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Licence
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
Description
Laboratory finding - Week 4
Alias
- UMLS CUI-1
- C0587081
Description
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Description
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
Description
Laboratory; Parameter Value
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Description
Comment | Laboratory; Parameter Value
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Description
AED plasma concentration - Week 4
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0683150
Description
Laboratory finding - Week 6
Alias
- UMLS CUI-1
- C0587081
Description
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Description
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
Description
Laboratory; Parameter Value
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Description
Comment | Laboratory; Parameter Value
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Description
AED plasma concentration - Week 6
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0683150
Description
Study Continuitation Record - Date of assessment
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-3
- C2985720
Description
Study Continuitation Record - Inclusion and Exclusion Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-3
- C1512693
- UMLS CUI-5
- C0680251
Description
Study Continuitation Record - Baseline Seizure Inclusion Criterion
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1512693
- UMLS CUI-3
- C0036572
- UMLS CUI-4
- C1442488
Description
This answer must be YES. If No, the patient will be withdrawn from the study.
Type de données
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
Description
Study Continuitation Record - Eligibility Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1516637
Description
Menarche; Visit; Last; Since
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0025274
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Description
If the answer is No, the patient will be withdrawn from the study.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Description
If the answer is No, the patient will be withdrawn from the study.
Type de données
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
Description
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.
Type de données
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])