ID

31918

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 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Trefwoorden

Versies (3)
  1. 30-09-18 30-09-18 -
  2. 08-10-18 08-10-18 -
  3. 08-10-18 08-10-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

8 oktober 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 105-040

Engels

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

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Beschrijving

Study Site; Numbers

Datatype

text

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Patient's initials
Beschrijving

Person Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Patient's trial number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Investigator Comment Log
Beschrijving

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
Comment Date
Beschrijving

Comment; Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0011008
Page number
Beschrijving

Page (document); Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0237753
Comments
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Patient Discharge Notification Postcard
Beschrijving

Patient Discharge Notification Postcard

Alias
UMLS CUI-1
C0030685
UMLS CUI-2
C0422202
Project number
Beschrijving

Project; Identification number

Datatype

integer

Alias
UMLS CUI [1,1]
C1709701
UMLS CUI [1,2]
C1300638
Protocol number
Beschrijving

Study Protocol; Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0237753
Site number
Beschrijving

Study Site; Numbers

Datatype

text

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Date discharged
Beschrijving

Discharge date

Datatype

date

Alias
UMLS CUI [1]
C2361123
Patient's initials
Beschrijving

Person Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Patient's trial number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Last dose of study drug record
Beschrijving

Last dose of study drug record

Alias
UMLS CUI-1
C3854006
UMLS CUI-2
C0178602
UMLS CUI-3
C0034869
UMLS CUI-4
C1517741
Was study drug stopped permanently before completion of all 18 weeks of treatment and taper?
Beschrijving

Experimental drug; Discontinuation (procedure) | Completion Status; Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [2,1]
C0805732
UMLS CUI [2,2]
C0087111
If study drug stopped, check the primary reason drug was stopped
Beschrijving

Experimental drug; Discontinuation (procedure); Indication of (contextual qualifier)

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0392360
Date of last dose
Beschrijving

Date last dose

Datatype

date

Alias
UMLS CUI [1]
C1762893
End of study record
Beschrijving

End of study record

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0444496
Did the patient complete the Screen, Baseline, Treatment Phases and Taper?
Beschrijving

Baseline; Complete | Screening procedure; Complete | treatment phases; Complete | Tapering - action; Complete

Datatype

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
If patient did not complete Screen, Baseline, Treatment Phases and Taper, check primary reason.
Beschrijving

Baseline; Screening procedure; treatment phases; Tapering - action; Complete; Reason and justification

Datatype

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
Date patient discharged from the study
Beschrijving

No further protocol specified treatments or evaluations are planned

Datatype

date

Alias
UMLS CUI [1,1]
C2361123
UMLS CUI [1,2]
C2603343
Did the patient die anytime during the study (Baseline Day 1 through Taper and Folllow-Up Phases?)
Beschrijving

Cessation of life; Clinical Trials; During

Datatype

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
If patient died, onset date of the event wich led to death
Beschrijving

Death Related to Adverse Event; Date of onset

Datatype

date

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C0574845
Date of death
Beschrijving

Date of death

Datatype

date

Alias
UMLS CUI [1]
C1148348
Characterize the cause of death
Beschrijving

Cause of Death

Datatype

integer

Alias
UMLS CUI [1]
C0007465
If other cause of death, specify.
Beschrijving

Cause of Death; Other; Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Check attribution of death to study medication
Beschrijving

Cessation of life; Experimental drug; attribution

Datatype

integer

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0596130
Was an autopsy performed?
Beschrijving

Autopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0004398
Status of randomization code/ Investigator's statement
Beschrijving

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
Was the blind on the randomization code for this patient broken?
Beschrijving

Randomization; Code; Blinded Clinical Study Unit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C2347038
UMLS CUI [1,4]
C3846158
Date of blind was broken
Beschrijving

Date in time; Blinded Clinical Study

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C3846158
Reason for breaking blind
Beschrijving

Date in time; Blinded Clinical Study

Datatype

text

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C3846158
Investigator's statement
Beschrijving

Investigator's statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
Investigator's Signature
Beschrijving

Investigator Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Beschrijving

Investigator Signature; Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name
Beschrijving

Investigator Name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Laboratory Comments - Unscheduled Laboratory Assessment
Beschrijving

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
Do you consider any of the laboratory values at this clinic visit to be of potential OR actual clinical significance AND unexpected in this patient population?
Beschrijving

Laboratory Results; Clinical Significance; Unexpected

Datatype

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C4055646
Laboratory results that are of potential or actual clinical significance and unexpected
Beschrijving

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
Laboratory parameter
Beschrijving

Laboratory; Parameter Value

Datatype

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0549193
Comment (Laboratory parameter)
Beschrijving

Comment | Laboratory; Parameter Value

Datatype

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2,1]
C0022877
UMLS CUI [2,2]
C0549193
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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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Site; Numbers
Item
Site number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Person Initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Comment; Date in time
Item
Comment Date
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Page (document); Numbers
Item
Page number
integer
C1704732 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Patient Discharge Notification Postcard
C0030685 (UMLS CUI-1)
C0422202 (UMLS CUI-2)
Project; Identification number
Item
Project number
integer
C1709701 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Study Protocol; Numbers
Item
Protocol number
integer
C2348563 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Study Site; Numbers
Item
Site number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Discharge date
Item
Date discharged
date
C2361123 (UMLS CUI [1])
Person Initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Item Group
Last dose of study drug record
C3854006 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0034869 (UMLS CUI-3)
C1517741 (UMLS CUI-4)
Experimental drug; Discontinuation (procedure) | Completion Status; Therapeutic procedure
Item
Was study drug stopped permanently before completion of all 18 weeks of treatment and taper?
boolean
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0805732 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Item
If study drug stopped, check the primary reason drug was stopped
integer
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Experimental drug; Discontinuation (procedure); Indication of (contextual qualifier)
Code List
If study drug stopped, check the primary reason drug was stopped
CL Item
Adverse Experience (record details on ADVERSEnEXPERIENCES pages) (1)
CL Item
Death (Check only, if death is NOT an outcome of an adverse experience) (2)
CL Item
Inadequate response to study drug (including seizure exacerbation) (3)
CL Item
Consent withdrawn (4)
CL Item
Lost to follow-up (5)
CL Item
Protocol violation (non- compliance or pregnancy) (6)
Date last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Item Group
End of study record
C0008976 (UMLS CUI-1)
C0444496 (UMLS CUI-2)
Baseline; Complete | Screening procedure; Complete | treatment phases; Complete | Tapering - action; Complete
Item
Did the patient complete the Screen, Baseline, Treatment Phases and Taper?
boolean
C1442488 (UMLS CUI [1,1])
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])
Item
If patient did not complete Screen, Baseline, Treatment Phases and Taper, check primary reason.
integer
C1442488 (UMLS CUI [1,1])
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])
undefined item
Code List
If patient did not complete Screen, Baseline, Treatment Phases and Taper, check primary reason.
CL Item
Adverse Experience (record details on ADVERSEnEXPERIENCES pages) (1)
CL Item
Death (Check only, if death is NOT an outcome of an adverse experience) (2)
CL Item
Inadequate response to study drug (including seizure exacerbation) (3)
CL Item
Consent withdrawn (4)
CL Item
Lost to follow-up (5)
CL Item
Protocol violation (non- compliance or pregnancy) (6)
Discharge date; Study
Item
Date patient discharged from the study
date
C2361123 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Cessation of life; Clinical Trials; During
Item
Did the patient die anytime during the study (Baseline Day 1 through Taper and Folllow-Up Phases?)
boolean
C0011065 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1442488 (UMLS CUI [2])
C0441640 (UMLS CUI [3])
C1522577 (UMLS CUI [4])
Death Related to Adverse Event; Date of onset
Item
If patient died, onset date of the event wich led to death
date
C1705232 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Characterize the cause of death
integer
C0007465 (UMLS CUI [1])
Cause of Death
Code List
Characterize the cause of death
CL Item
Accidental (1)
CL Item
Seizure- related (If seizure- related, check one) (2)
CL Item
Aspiration (3)
CL Item
Status epilepticus (4)
CL Item
Drowning (5)
CL Item
Other (specify) (6)
Cause of Death; Other; Specification
Item
If other cause of death, specify.
text
C0007465 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Check attribution of death to study medication
integer
C0011065 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0596130 (UMLS CUI [1,3])
undefined item
Code List
Check attribution of death to study medication
CL Item
Not a reasonable possibility (1)
CL Item
A resonable possibility (2)
Autopsy
Item
Was an autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Item Group
Status of randomization code/ Investigator's statement
C0034656 (UMLS CUI-1)
C0805701 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0008961 (UMLS CUI-4)
C1710187 (UMLS CUI-5)
Randomization; Code; Blinded Clinical Study Unit
Item
Was the blind on the randomization code for this patient broken?
boolean
C0034656 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C2347038 (UMLS CUI [1,3])
C3846158 (UMLS CUI [1,4])
Date in time; Blinded Clinical Study
Item
Date of blind was broken
date
C0011008 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
Date in time; Blinded Clinical Study
Item
Reason for breaking blind
text
C0011008 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
Item Group
Investigator's statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Investigator Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature; Date in time
Item
Date of Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Item Group
Laboratory Comments - Unscheduled Laboratory Assessment
C0022877 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0022877 (UMLS CUI-4)
C3854240 (UMLS CUI-5)
Laboratory Results; Clinical Significance; Unexpected
Item
Do you consider any of the laboratory values at this clinic visit to be of potential OR actual clinical significance AND unexpected in this patient population?
boolean
C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
Item Group
Laboratory results that are of potential or actual clinical significance and unexpected
C1254595 (UMLS CUI-1)
C2826293 (UMLS CUI-2)
C4055646 (UMLS CUI-3)
Laboratory; Parameter Value
Item
Laboratory parameter
text
C0022877 (UMLS CUI [1,1])
C0549193 (UMLS CUI [1,2])
Comment | Laboratory; Parameter Value
Item
Comment (Laboratory parameter)
text
C0947611 (UMLS CUI [1])
C0022877 (UMLS CUI [2,1])
C0549193 (UMLS CUI [2,2])
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