ID
31918
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
Keywords
Versions (3)
- 9/30/18 9/30/18 -
- 10/8/18 10/8/18 -
- 10/8/18 10/8/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 8, 2018
DOI
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License
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
Investigator Comment Log, Patient Discharge Notification Postcard, Last Dose of Study Drug Record, End of Study Record, Status of Randomization Code/ Investigator's Statement and Laboratory Comments
Description
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Description
Comment; Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0011008
Description
Page (document); Numbers
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C0237753
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Patient Discharge Notification Postcard
Alias
- UMLS CUI-1
- C0030685
- UMLS CUI-2
- C0422202
Description
Project; Identification number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1709701
- UMLS CUI [1,2]
- C1300638
Description
Study Protocol; Numbers
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0237753
Description
Study Site; Numbers
Data type
text
Alias
- UMLS CUI [1,1]
- C2825164
- UMLS CUI [1,2]
- C0237753
Description
Discharge date
Data type
date
Alias
- UMLS CUI [1]
- C2361123
Description
Person Initials
Data type
text
Alias
- UMLS CUI [1]
- C2986440
Description
Clinical Trial Subject Unique Identifier
Data type
text
Alias
- UMLS CUI [1]
- C2348585
Description
Last dose of study drug record
Alias
- UMLS CUI-1
- C3854006
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C0034869
- UMLS CUI-4
- C1517741
Description
Experimental drug; Discontinuation (procedure) | Completion Status; Therapeutic procedure
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [2,1]
- C0805732
- UMLS CUI [2,2]
- C0087111
Description
Experimental drug; Discontinuation (procedure); Indication of (contextual qualifier)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0392360
Description
Date last dose
Data type
date
Alias
- UMLS CUI [1]
- C1762893
Description
End of study record
Alias
- UMLS CUI-1
- C0008976
- UMLS CUI-2
- C0444496
Description
Baseline; Complete | Screening procedure; Complete | treatment phases; Complete | Tapering - action; Complete
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1442488
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [2,1]
- C0220908
- UMLS CUI [2,2]
- C0205197
- UMLS CUI [3,1]
- C0815181
- UMLS CUI [3,2]
- C0205197
- UMLS CUI [4,1]
- C0441640
- UMLS CUI [4,2]
- C0205197
Description
Baseline; Screening procedure; treatment phases; Tapering - action; Complete; Reason and justification
Data type
integer
Alias
- UMLS CUI [1,1]
- C1442488
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0566251
- UMLS CUI [2,1]
- C0220908
- UMLS CUI [2,2]
- C0205197
- UMLS CUI [2,3]
- C0566251
- UMLS CUI [3,1]
- C0815181
- UMLS CUI [3,2]
- C0205197
- UMLS CUI [3,3]
- C0566251
- UMLS CUI [4,1]
- C0441640
- UMLS CUI [4,2]
- C0205197
- UMLS CUI [4,3]
- C0566251
Description
No further protocol specified treatments or evaluations are planned
Data type
date
Alias
- UMLS CUI [1,1]
- C2361123
- UMLS CUI [1,2]
- C2603343
Description
Cessation of life; Clinical Trials; During
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [2]
- C1442488
- UMLS CUI [3]
- C0441640
- UMLS CUI [4]
- C1522577
Description
Death Related to Adverse Event; Date of onset
Data type
date
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0574845
Description
Date of death
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Cause of Death
Data type
integer
Alias
- UMLS CUI [1]
- C0007465
Description
Cause of Death; Other; Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Cessation of life; Experimental drug; attribution
Data type
integer
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0596130
Description
Autopsy
Data type
boolean
Alias
- UMLS CUI [1]
- C0004398
Description
Status of randomization code/ Investigator's statement
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0805701
- UMLS CUI-3
- C0449438
- UMLS CUI-4
- C0008961
- UMLS CUI-5
- C1710187
Description
Randomization; Code; Blinded Clinical Study Unit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C2347038
- UMLS CUI [1,4]
- C3846158
Description
Date in time; Blinded Clinical Study
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2347038
- UMLS CUI [1,3]
- C3846158
Description
Date in time; Blinded Clinical Study
Data type
text
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2347038
- UMLS CUI [1,3]
- C3846158
Description
Investigator's statement
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1710187
Description
Investigator Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature; Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Laboratory Comments - Unscheduled Laboratory Assessment
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C0947611
- UMLS CUI-3
- C0220825
- UMLS CUI-4
- C0022877
- UMLS CUI-5
- C3854240
Description
Laboratory Results; Clinical Significance; Unexpected
Data type
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
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C2826293
- UMLS CUI-3
- C4055646
Description
Laboratory; Parameter Value
Data type
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Description
Comment | Laboratory; Parameter Value
Data type
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Similar models
Investigator Comment Log, Patient Discharge Notification Postcard, Last Dose of Study Drug Record, End of Study Record, Status of Randomization Code/ Investigator's Statement and Laboratory Comments
C0237753 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0422202 (UMLS CUI-2)
C1300638 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0178602 (UMLS CUI-2)
C0034869 (UMLS CUI-3)
C1517741 (UMLS CUI-4)
C0457454 (UMLS CUI [1,2])
C0805732 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0457454 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0444496 (UMLS CUI-2)
C0205197 (UMLS CUI [1,2])
C0220908 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0815181 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0441640 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0205197 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0220908 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0566251 (UMLS CUI [2,3])
C0815181 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0566251 (UMLS CUI [3,3])
C0441640 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0566251 (UMLS CUI [4,3])
C2603343 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1442488 (UMLS CUI [2])
C0441640 (UMLS CUI [3])
C1522577 (UMLS CUI [4])
C0574845 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0596130 (UMLS CUI [1,3])
C0805701 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0008961 (UMLS CUI-4)
C1710187 (UMLS CUI-5)
C0805701 (UMLS CUI [1,2])
C2347038 (UMLS CUI [1,3])
C3846158 (UMLS CUI [1,4])
C2347038 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
C2347038 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
C1710187 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0022877 (UMLS CUI-4)
C3854240 (UMLS CUI-5)
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])
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