ID

36218

Descripción

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Palabras clave

Versiones (1)
  1. 23/4/19 23/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

23 de abril de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

Inglés

Serious Adverse Event (SAE)

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Descripción

Study Coordinating Center, Identification number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Randomization Number
Descripción

Randomization, Identification Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1300638
Serious Adverse Events - Section 1
Descripción

Serious Adverse Events - Section 1

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse event during the study?
Descripción

Serious Adverse Event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Event
Descripción

Serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Start Date
Descripción

Serious Adverse Event, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Start Time
Descripción

Serious Adverse Event, Start time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Outcome
Descripción

Serious Adverse Event, Adverse Event Outcome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date
Descripción

Serious Adverse Event, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
End Time
Descripción

Serious Adverse Event, End Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522314
Maximum Intensity
Descripción

Serious Adverse Event, Severity of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710066
Action Taken with lnvestigational Producl(s) as a ResuIt of the SAE
Descripción

Serious Adverse Event, Action Taken with Study Treatment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this SAE?
Descripción

Serious Adverse Event, Withdraw

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Descripción

Serious Adverse Event, Relationship, Experimental drug

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
If fatal, was a post-mortem/autopsy performed?
Descripción

Serious Adverse Event, Fatal, Autopsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0004398
Seriousness
Descripción

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710066
Seriousness (specify reason(s) for considering this a SAE, check all that apply)
Descripción

Serious Adverse Event, Severity of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710066
Demography Data
Descripción

Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0011298
Date of birth
Descripción

Patient date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Sex
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Weight
Descripción

Body Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Descripción

If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0439849
UMLS CUI-3
C0304229
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Descripción

Serious Adverse Event, Relationship, Experimental drug

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Possible Causes of SAE Other Than lnvestigational Product(s)
Descripción

Possible Causes of SAE Other Than lnvestigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
Possible Causes of SAE Other Than lnvestigational Product(s), check all that apply
Descripción

Serious Adverse Event, Causations

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Relevant Medical Conditions
Descripción

Relevant Medical Conditions

Alias
UMLS CUI-1
C0012634
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Descripción

Medical History; Hypersensitivity; Operative Surgical Procedures

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0543467
Date of Onset
Descripción

Disease, Date of Onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Condition Present at Time of the SAE?
Descripción

Disease, During, Serious Adverse Event

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1519255
lf No, Date of Last Occurrence
Descripción

Disease, Occurrence, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0011008
Other Relevant Risk Factors
Descripción

Other Relevant Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
Other RELEVANT Risk Factors (provide any family or social history (e.g.. smoking, alcohol. diet, drug abuse. occupational hazard) relevant to the SAE)
Descripción

Serious Adverse Event, Risk factor

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0035648
Relevant Concomitant Medications
Descripción

Relevant Concomitant Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Drug Name
Descripción

Serious Adverse Event, Concomitant Agent, Medication name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Dose
Descripción

Serious Adverse Event, Concomitant Agent, Medication dose

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3174092
Unit
Descripción

Serious Adverse Event, Concomitant Agent, Unit

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439148
Frequency
Descripción

Serious Adverse Event, Concomitant Agent, Frequencies

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439603
Route
Descripción

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Taken Prior to Study?
Descripción

Serious Adverse Event, Concomitant Medication Previous Occurence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826667
Start Date
Descripción

Serious Adverse Event, Concomitant Agent, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0808070
Stop Date
Descripción

Serious Adverse Event, Concomitant Agent, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Ongoing Medication?
Descripción

Serious Adverse Event, Concomitant Medication Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826666
Reason for Medication
Descripción

Serious Adverse Event, Concomitant Agent, Indication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0392360
Details of lnvestigational Product(s)
Descripción

Details of lnvestigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Date of Dose
Descripción

Serious Adverse Event, Experimental drug, Dosage, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0011008
Time of Dose
Descripción

Serious Adverse Event, Experimental drug, Dosage, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0040223
Details of Relevant Assessments
Descripción

Details of Relevant Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
UMLS CUI-3
C1522508
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
Descripción

Serious Adverse Event, Evaluation, Details

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1522508
Narrative Remarks
Descripción

Narrative Remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Narrative Remarks (provide a brief narrative description ofthe SAE and details of treatment given)
Descripción

Serious Adverse Event, Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Investigator Signature
Descripción

Investigator Signature

Alias
UMLS CUI-1
C2346576
Investigator Signature
Descripción

Investigator Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date
Descripción

Investigator Signature, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name (print)
Descripción

Investigator Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Serious Adverse Event (SAE)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Randomization, Identification Number
Item
Randomization Number
integer
C0034656 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Serious Adverse Events - Section 1
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event
Item
Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event, Start time
Item
Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/ Resolved  (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
CL Item
Fatal (5)
Serious Adverse Event, End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, End Time
Item
End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
Code List
Maximum Intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe  (3)
CL Item
Not applicable (4)
Item
Action Taken with lnvestigational Producl(s) as a ResuIt of the SAE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
Code List
Action Taken with lnvestigational Producl(s) as a ResuIt of the SAE
CL Item
lnvestigational 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)
Serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Relationship, Experimental drug
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Fatal, Autopsy
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710066 (UMLS CUI-2)
Item
Seriousness (specify reason(s) for considering this a SAE, check all that apply)
text
C1519255 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Serious Adverse Event, Severity of Adverse Event
Code List
Seriousness (specify reason(s) for considering this a SAE, check all that apply)
CL Item
Results in death  (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other (6)
Item Group
Demography Data
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
C1519255 (UMLS CUI-1)
C0439849 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Item
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Relationship, Experimental drug
Code List
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
CL Item
Yes  (1)
CL Item
No (2)
CL Item
Unknown at this time  (3)
CL Item
Not applicable (4)
Item Group
Possible Causes of SAE Other Than lnvestigational Product(s)
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than lnvestigational Product(s), check all that apply
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Serious Adverse Event, Causations
Code List
Possible Causes of SAE Other Than lnvestigational Product(s), check all that apply
CL Item
Disease under study (1)
CL Item
Medical condition(s) (record in Section 6)  (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication (record in Section 8) (5)
CL Item
Activity related to study participation (e.g. , procedures)  (6)
CL Item
Other (7)
Item Group
Relevant Medical Conditions
C0012634 (UMLS CUI-1)
Medical History; Hypersensitivity; Operative Surgical Procedures
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Disease, Date of Onset
Item
Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Disease, During, Serious Adverse Event
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Disease, Occurrence, Date in time
Item
lf No, Date of Last Occurrence
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Other Relevant Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Serious Adverse Event, Risk factor
Item
Other RELEVANT Risk Factors (provide any family or social history (e.g.. smoking, alcohol. diet, drug abuse. occupational hazard) relevant to the SAE)
text
C1519255 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
Item Group
Relevant Concomitant Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Serious Adverse Event, Concomitant Agent, Medication name
Item
Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Medication dose
Item
Dose
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Medication Previous Occurence
Item
Taken Prior to Study?
boolean
C1519255 (UMLS CUI [1,1])
C2826667 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Medication Ongoing
Item
Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Indication
Item
Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Details of lnvestigational Product(s)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Serious Adverse Event, Experimental drug, Dosage, Date in time
Item
Date of Dose
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Serious Adverse Event, Experimental drug, Dosage, Time
Item
Time of Dose
time
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Details of Relevant Assessments
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Serious Adverse Event, Evaluation, Details
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
text
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item Group
Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Narrative Remarks (provide a brief narrative description ofthe SAE and details of treatment given)
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
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