ID

37679

Beschrijving

Study ID: 105377 Clinical Study ID: 105377 Study Title: A randomised, open-label, parallel-group design study to evaluate the pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Epilepsy

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  1. 16-08-19 16-08-19 -
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GlaxoSmithKline

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16 augustus 2019

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Creative Commons BY-NC 3.0
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Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377)

Engels

Logs/ Repeats - Logs and Repeats; Adverse Events

1 Formulieren  
Logs and Repeats
Beschrijving

Logs and Repeats

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0205341
Date of visit/assessment
Beschrijving

Date of visit/assessment

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions
Beschrijving

Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0205341
UMLS CUI-3
C0877248
UMLS CUI-4
C1516048
UMLS CUI-5
C2347852
UMLS CUI-6
C1516048
Were any concomitant medications taken by the subject during the study?
Beschrijving

Were any concomitant medications taken by the subject during the study?

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any adverse events during the study?
Beschrijving

Did the subject experience any adverse events during the study?

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Were any repeat haematology or clinical chemistry samples taken?
Beschrijving

Were any repeat haematology or clinical chemistry samples taken?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0200345
Were any repeat urinalysis samples taken?
Beschrijving

Were any repeat urinalysis samples taken?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0205341
Were any repeat vital signs recorded?
Beschrijving

Were any repeat vital signs recorded?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat vital signs recorded?
Beschrijving

Were any repeat vital signs recorded?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat PK samples taken?
Beschrijving

Were any repeat PK samples taken?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
UMLS CUI [1,3]
C0205341
Adverse Event (AE)
Beschrijving

Adverse Event (AE)

Alias
UMLS CUI-1
C0877248
Adverse Event - Sequence Number
Beschrijving

Adverse Event - Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348184
Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

Alias
UMLS CUI [1]
C0877248
Adverse Event - Modified term
Beschrijving

Adverse Event - Modified term

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
Adverse Event - MedDRA synonym
Beschrijving

Adverse Event - MedDRA synonym

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1140263
Adverse Event - MedDRA lower level term code
Beschrijving

Adverse Event - MedDRA lower level term code

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3898442
Adverse Event - Failed coding
Beschrijving

Adverse Event - Failed coding

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Adverse Event Start Date and Time
Beschrijving

Adverse Event Start Date and Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826806
Adverse Event Outcome
Beschrijving

Adverse Event Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Adverse Event End Date and Time
Beschrijving

Adverse Event End Date and Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826793
Adverse Event - Date and Time of Death
Beschrijving

Adverse Event - Date and Time of Death

Datatype

datetime

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1148348
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1301931
Adverse Event Frequency
Beschrijving

Adverse Event Frequency

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439603
Adverse Event Maximum Intensity
Beschrijving

Adverse Event Maximum Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Action Taken with Investigational Product(s) as a Result of the AE
Beschrijving

Action Taken with Investigational Product(s) as a Result of the AE

Datatype

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschrijving

Did the subject withdraw from study as a result of this AE?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Does this Adverse Event meet the definition of serious?
Beschrijving

If Yes, complete paper SAE form and fax to GSK Safety within 24 hr

Datatype

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse event Outcome
Beschrijving

Check all that apply

Datatype

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
If other Serious Adverse Event Outcome, specify
Beschrijving

If other Serious Adverse Event Outcome, specify

Datatype

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Was this SAE caused by an activity related to study participation (e.g., procedures)?
Beschrijving

Was this SAE caused by an activity related to study participation (e.g., procedures)?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3641099
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Similar models

Logs/ Repeats - Logs and Repeats; Adverse Events

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Logs and Repeats
C1708728 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions
C1708728 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C1516048 (UMLS CUI-4)
C2347852 (UMLS CUI-5)
C1516048 (UMLS CUI-6)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Did the subject experience any adverse events during the study?
Item
Did the subject experience any adverse events during the study?
boolean
C0877248 (UMLS CUI [1])
Were any repeat haematology or clinical chemistry samples taken?
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Were any repeat urinalysis samples taken?
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat PK samples taken?
Item
Were any repeat PK samples taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Item Group
Adverse Event (AE)
C0877248 (UMLS CUI-1)
Adverse Event - Sequence Number
Item
Adverse Event - Sequence Number
integer
C0877248 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Adverse Event - Modified term
Item
Adverse Event - Modified term
text
C0877248 (UMLS CUI [1,1])
Adverse Event - MedDRA synonym
Item
Adverse Event - MedDRA synonym
text
C0877248 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Adverse Event - MedDRA lower level term code
Item
Adverse Event - MedDRA lower level term code
text
C0877248 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Adverse Event - Failed coding
Item
Adverse Event - Failed coding
text
C0877248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Adverse Event Start Date and Time
Item
Adverse Event Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Adverse Event Outcome
integer
C1705586 (UMLS CUI [1])
Non-serious Adverse Event Outcome
Code List
Adverse Event Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
(Comment:en)
CL Item
Recovering/Resolving (2)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
(Comment:en)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
(Comment:en)
CL Item
Fatal, record Date and Time of Death (5 )
(Comment:en)
Adverse Event End Date and Time
Item
Adverse Event End Date and Time
datetime
C2826793 (UMLS CUI [1])
Adverse Event - Date and Time of Death
Item
Adverse Event - Date and Time of Death
datetime
C0877248 (UMLS CUI [1,1])
C1148348 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C1301931 (UMLS CUI [2,2])
Item
Adverse Event Frequency
integer
C0877248 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious Adverse Event Frequency
Code List
Adverse Event Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Adverse Event Maximum Intensity
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Non-serious Adverse Event Maximum Intensity
Code List
Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Does this Adverse Event meet the definition of serious?
text
C1519255 (UMLS CUI [1])
Does this Adverse Event meet the definition of serious?
Code List
Does this Adverse Event meet the definition of serious?
CL Item
No (N)
CL Item
Yes (Y)
Item
Serious Adverse event Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse event Outcome
Code List
Serious Adverse event Outcome
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongati.on of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
If other Serious Adverse Event Outcome, specify
Item
If other Serious Adverse Event Outcome, specify
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Was this SAE caused by an activity related to study participation (e.g., procedures)?
Item
Was this SAE caused by an activity related to study participation (e.g., procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C3641099 (UMLS CUI [1,2])
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