ID
31707
Beschrijving
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 Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial
Trefwoorden
Versies (4)
- 22-09-18 22-09-18 -
- 27-09-18 27-09-18 -
- 08-10-18 08-10-18 -
- 11-10-18 11-10-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
22 september 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients
Laboratory Comments - Baseline Week 4 and 6 and Study Continuation Record - Baseline Study Week 8
Beschrijving
Laboratory finding - Week 4
Alias
- UMLS CUI-1
- C0587081
Beschrijving
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Beschrijving
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
Beschrijving
Laboratory; Parameter Value
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Beschrijving
Comment | Laboratory; Parameter Value
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Beschrijving
Laboratory finding - Week 6
Alias
- UMLS CUI-1
- C0587081
Beschrijving
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Beschrijving
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
Beschrijving
Laboratory; Parameter Value
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Beschrijving
Comment | Laboratory; Parameter Value
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Beschrijving
Study Continuitation Record - Date of assessment
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-3
- C2985720
Beschrijving
Study Continuitation Record - Inclusion and Exclusion Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-3
- C1512693
- UMLS CUI-5
- C0680251
Beschrijving
Study Continuitation Record - Baseline Seizure Inclusion Criterion
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1512693
- UMLS CUI-3
- C0036572
- UMLS CUI-4
- C1442488
Beschrijving
This answer must be YES. If No, the patient will be withdrawn from the study.
Datatype
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
Beschrijving
Study Continuitation Record - Eligibility Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1516637
Beschrijving
Menarche; Visit; Last; Since
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0025274
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Beschrijving
If the answer is No, the patient will be withdrawn from the study.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Beschrijving
If the answer is No, the patient will be withdrawn from the study.
Datatype
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
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710187
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0032961
- UMLS CUI [1,4]
- C0870186
Similar models
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])
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])
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])