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

Keywords

Versions (4)
  1. 9/22/18 9/22/18 -
  2. 9/27/18 9/27/18 -
  3. 10/8/18 10/8/18 -
  4. 10/11/18 10/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 11, 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

English

AED Plasma Concentration - Baseline Week 4 and 6, Laboratory Comments - Baseline Week 4 and 6 and Study Continuation Record - Baseline Study Week 8

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Description

Study Site; Numbers

Data type

text

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

Person Initials

Data type

text

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

Clinical Trial Subject Unique Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Date sample collected - Week 4
Description

Specimen collection date

Data type

date

Alias
UMLS CUI [1]
C1302413
Date sample collected - Week 6
Description

Specimen collection date

Data type

date

Alias
UMLS CUI [1]
C1302413
Laboratory finding - Week 4
Description

Laboratory finding - Week 4

Alias
UMLS CUI-1
C0587081
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?
Description

If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).

Data type

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 - Week 4
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
Laboratory parameter
Description

Laboratory; Parameter Value

Data type

text

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

Comment | Laboratory; Parameter Value

Data type

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2,1]
C0022877
UMLS CUI [2,2]
C0549193
AED plasma concentration - Week 4
Description

AED plasma concentration - Week 4

Alias
UMLS CUI-1
C0003299
UMLS CUI-2
C0683150
AED plasma concentration
Description

Antiepileptic Agents; plasma concentration

Data type

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0683150
Laboratory finding - Week 6
Description

Laboratory finding - Week 6

Alias
UMLS CUI-1
C0587081
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?
Description

If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).

Data type

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 - Week 6
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
Laboratory parameter
Description

Laboratory; Parameter Value

Data type

text

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

Comment | Laboratory; Parameter Value

Data type

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2,1]
C0022877
UMLS CUI [2,2]
C0549193
AED plasma concentration - Week 6
Description

AED plasma concentration - Week 6

Alias
UMLS CUI-1
C0003299
UMLS CUI-2
C0683150
AED plasma concentration
Description

Antiepileptic Agents; plasma concentration

Data type

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0683150
Study Continuitation Record - Date of assessment
Description

Study Continuitation Record - Date of assessment

Alias
UMLS CUI-1
C2348568
UMLS CUI-3
C2985720
Date of assessment
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Study Continuitation Record - Inclusion and Exclusion Criteria
Description

Study Continuitation Record - Inclusion and Exclusion Criteria

Alias
UMLS CUI-1
C2348568
UMLS CUI-3
C1512693
UMLS CUI-5
C0680251
Does the patient continue to meet the Inclusion and Exclusion Criteria?
Description

This answer must be YES. If No, the patient will be withdrawn from the study.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Study Continuitation Record - Baseline Seizure Inclusion Criterion
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
Has the investigator judged that this patient had at least four seizures during each of the two consecutive 4- week intervals and the patient's maximum seizure- free interval during entire Baseline Phase did not exceed 4 weeks?
Description

This answer must be YES. If No, the patient will be withdrawn from the study.

Data type

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
Study Continuitation Record - Eligibility Criteria
Description

Study Continuitation Record - Eligibility Criteria

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C1516637
Has this patient become menarcheal since the last clinic visit?
Description

Menarche; Visit; Last; Since

Data type

boolean

Alias
UMLS CUI [1,1]
C0025274
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1711239
If patient become menarcheal since the last clinic visit, is this patient not currently pregnant (the result of a serum pregnancy test conducted at this visit is negative) or breastfeeding?
Description

If the answer is No, the patient will be withdrawn from the study.

Data type

boolean

Alias
UMLS CUI [1]
C0025274
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0430061
UMLS CUI [4]
C0006147
Does this patient employ a contraceptive method (whether a drug, device or abstinence) acceptable to the investigator?
Description

If the answer is No, the patient will be withdrawn from the study.

Data type

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
Has this patient either signed or have had signed by a parent or guardian on their behalf, a statement of intent to avoid pregnancy?
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.

Data type

boolean

Alias
UMLS CUI [1,1]
C1710187
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C0032961
UMLS CUI [1,4]
C0870186
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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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Specimen collection date
Item
Date sample collected - Week 4
date
C1302413 (UMLS CUI [1])
Specimen collection date
Item
Date sample collected - Week 6
date
C1302413 (UMLS CUI [1])
Item Group
Laboratory finding - Week 4
C0587081 (UMLS CUI-1)
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 - Week 4
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])
Item Group
AED plasma concentration - Week 4
C0003299 (UMLS CUI-1)
C0683150 (UMLS CUI-2)
Antiepileptic Agents; plasma concentration
Item
AED plasma concentration
text
C0003299 (UMLS CUI [1,1])
C0683150 (UMLS CUI [1,2])
Item Group
Laboratory finding - Week 6
C0587081 (UMLS CUI-1)
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 - Week 6
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])
Item Group
AED plasma concentration - Week 6
C0003299 (UMLS CUI-1)
C0683150 (UMLS CUI-2)
Antiepileptic Agents; plasma concentration
Item
AED plasma concentration
text
C0003299 (UMLS CUI [1,1])
C0683150 (UMLS CUI [1,2])
Item Group
Study Continuitation Record - Date of assessment
C2348568 (UMLS CUI-1)
C2985720 (UMLS CUI-3)
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item Group
Study Continuitation Record - Inclusion and Exclusion Criteria
C2348568 (UMLS CUI-1)
C1512693 (UMLS CUI-3)
C0680251 (UMLS CUI-5)
Inclusion; Exclusion Criteria
Item
Does the patient continue to meet the Inclusion and Exclusion Criteria?
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Item Group
Study Continuitation Record - Baseline Seizure Inclusion Criterion
C2348568 (UMLS CUI-1)
C1512693 (UMLS CUI-2)
C0036572 (UMLS CUI-3)
C1442488 (UMLS CUI-4)
Seizures; Count; Interval ; During | Seizure free; Interval; Baseline; During
Item
Has the investigator judged that this patient had at least four seizures during each of the two consecutive 4- week intervals and the patient's maximum seizure- free interval during entire Baseline Phase did not exceed 4 weeks?
boolean
C0036572 (UMLS CUI [1,1])
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])
Item Group
Study Continuitation Record - Eligibility Criteria
C2348568 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Menarche; Visit; Last; Since
Item
Has this patient become menarcheal since the last clinic visit?
boolean
C0025274 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
Menarche | Pregnancy | Serum pregnancy test negative | Breast Feeding
Item
If patient become menarcheal since the last clinic visit, is this patient not currently pregnant (the result of a serum pregnancy test conducted at this visit is negative) or breastfeeding?
boolean
C0025274 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Contraceptive methods; Pharmaceutical Preparations | Contraceptive methods; Devices | Contraceptive methods; Abstinence
Item
Does this patient employ a contraceptive method (whether a drug, device or abstinence) acceptable to the investigator?
boolean
C0700589 (UMLS CUI [1,1])
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])
Statement; Signature; Pregnancy; avoidance
Item
Has this patient either signed or have had signed by a parent or guardian on their behalf, a statement of intent to avoid pregnancy?
boolean
C1710187 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0870186 (UMLS CUI [1,4])
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