ID

32008

Beschreibung

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

Stichworte

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Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. Oktober 2018

DOI

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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

Englisch

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

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Beschreibung

Study Site; Numbers

Datentyp

text

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

Person Initials

Datentyp

text

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

Clinical Trial Subject Unique Identifier

Datentyp

text

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

Specimen collection date

Datentyp

date

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

Specimen collection date

Datentyp

date

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

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?
Beschreibung

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

Datentyp

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
Beschreibung

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
Beschreibung

Laboratory; Parameter Value

Datentyp

text

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

Comment | Laboratory; Parameter Value

Datentyp

text

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

AED plasma concentration - Week 4

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

Antiepileptic Agents; plasma concentration

Datentyp

text

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

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?
Beschreibung

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

Datentyp

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
Beschreibung

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
Beschreibung

Laboratory; Parameter Value

Datentyp

text

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

Comment | Laboratory; Parameter Value

Datentyp

text

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

AED plasma concentration - Week 6

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

Antiepileptic Agents; plasma concentration

Datentyp

text

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

Study Continuitation Record - Date of assessment

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

Assessment Date

Datentyp

date

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

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?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Study Continuitation Record - Baseline Seizure Inclusion Criterion
Beschreibung

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?
Beschreibung

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

Datentyp

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
Beschreibung

Study Continuitation Record - Eligibility Criteria

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

Menarche; Visit; Last; Since

Datentyp

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?
Beschreibung

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

Datentyp

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?
Beschreibung

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

Datentyp

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?
Beschreibung

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.

Datentyp

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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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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