ID
38054
Description
Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures
Keywords
Versions (1)
- 9/12/19 9/12/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 12, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)
Visit 1 / Screen - Haematology/ Clinical Chemistry; AED Plasma Concentration
Description
Haematology
Alias
- UMLS CUI-1
- C0018941
Description
Haematology - Date sample collected
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0018941
Description
Haematology - Laboratory number
Data type
text
Alias
- UMLS CUI [1,1]
- C2986056
- UMLS CUI [1,2]
- C0018941
Description
If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant
Data type
text
Alias
- UMLS CUI [1]
- C0518015
Description
If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant
Data type
text
Alias
- UMLS CUI [1]
- C0032181
Description
If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant
Data type
text
Alias
- UMLS CUI [1]
- C0023508
Description
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Description
Clinical Chemistry - Date sample collected
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0008000
Description
Clinical Chemistry - Laboratory number
Data type
text
Alias
- UMLS CUI [1,1]
- C2986056
- UMLS CUI [1,2]
- C0008000
Description
If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant
Data type
text
Alias
- UMLS CUI [1]
- C0201976
Description
If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant
Data type
text
Alias
- UMLS CUI [1]
- C0201836
Description
If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant
Data type
text
Alias
- UMLS CUI [1]
- C0201899
Description
Plasma Concentrations of AEDs
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0683150
Description
AED plasma concentration - Date of sample
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0003299
- UMLS CUI [1,3]
- C0683150
Description
Drug NOT including Study Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0304229
Description
Time since last dose
Data type
durationDatetime
Measurement units
- hrs
Alias
- UMLS CUI [1,1]
- C0946444
- UMLS CUI [1,2]
- C1711239
Description
Medication Concentration Value
Data type
float
Alias
- UMLS CUI [1,1]
- C0683150
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1522609
Description
Medication Concentration Units
Data type
text
Alias
- UMLS CUI [1,1]
- C0683150
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1519795
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Visit 1 / Screen - Haematology/ Clinical Chemistry; AED Plasma Concentration
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