ID

36228

Beschreibung

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

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Versionen (1)
  1. 23.04.19 23.04.19 -
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GlaxoSmithKline

Hochgeladen am

23. April 2019

DOI

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Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

Englisch

Pregnancy Notification Form (Subject's Partner)

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Study Coordinating Center, Identification number

Datentyp

integer

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

Identification number, Randomization

Datentyp

integer

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0034656
Mother's Relevant Medical/Family History
Beschreibung

Mother's Relevant Medical/Family History

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C0026591
UMLS CUI-3
C0262926
Mother's date of birth
Beschreibung

Pregnancy, Mother, Date of birth

Datentyp

date

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C0421451
Date of last menstrual period
Beschreibung

Pregnancy, Mother, Date of last menstrual period

Datentyp

date

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C0425932
Estimated date of delivery
Beschreibung

Pregnancy, Mother, Estimated date of delivery

Datentyp

date

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C1287845
Was the mother using a method of contraception?
Beschreibung

Pregnancy, Mother, Contraceptive method

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C0700589
ff Yes, specify
Beschreibung

Pregnancy, Mother, Contraceptive method

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C0700589
Type of conception, check one
Beschreibung

Pregnancy, Mother, Conception method

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C2598844
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Beschreibung

Pregnancy, Mother, Laboratory Procedures, Medical Procedures

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C0022885
UMLS CUI [1,4]
C0199171
Number of previous pregnancies (specify: Pre-term, Full-term, Normal births, Stillbirths, Children born with defects, Spontaneous abortions, Elective abortions, Other)
Beschreibung

Pregnancy, Mother, Number of Previous Pregnancies

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C0422807
Record details of children born with defects
Beschreibung

Pregnancy, Mother, Congenital Abnormality, number of children

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C0000768
UMLS CUI [1,4]
C2229974
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Beschreibung

Pregnancy, Mother, Risk factors, Pregnancy Outcome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C0035648
UMLS CUI [1,4]
C0032972
ff Yes, specify
Beschreibung

Pregnancy, Mother, Risk factors, Pregnancy Outcome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C0035648
UMLS CUI [1,4]
C0032972
Father's Relevant Medical/Family History
Beschreibung

Father's Relevant Medical/Family History

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C0015671
UMLS CUI-3
C0262926
Father's Relevant Medical/Family History (Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/ chromosomal disorders and medication use}
Beschreibung

Pregnancy, Father, Medical History

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0015671
UMLS CUI [1,3]
C0262926
Drug Exposures
Beschreibung

Drug Exposures

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C0743284
Drug Name
Beschreibung

Drug exposure during pregnancy, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C0877161
UMLS CUI [1,2]
C2360065
Route of Administration or Formulation
Beschreibung

Drug exposure during pregnancy, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C0877161
UMLS CUI [1,2]
C0013153
Total Daily Dose
Beschreibung

Drug exposure during pregnancy, Daily Dose, Total

Datentyp

text

Alias
UMLS CUI [1,1]
C0877161
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Units
Beschreibung

Drug exposure during pregnancy, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0877161
UMLS CUI [1,2]
C1519795
Started Pre-Study
Beschreibung

Drug exposure during pregnancy, Start Date, Before, Clinical Trial Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877161
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
Start Date
Beschreibung

Drug exposure during pregnancy, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0877161
UMLS CUI [1,2]
C0808070
Stop Date
Beschreibung

Drug exposure during pregnancy, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0877161
UMLS CUI [1,2]
C0806020
Ongoing Medication
Beschreibung

Drug exposure during pregnancy, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877161
UMLS CUI [1,2]
C0549178
Reason for Medication
Beschreibung

Drug exposure during pregnancy, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C0877161
UMLS CUI [1,2]
C3146298
Was the subject withdrawn from the study as a result of this pregnancy?
Beschreibung

Pregnancy, Withdraw

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2349954
Reporting Investigator Information
Beschreibung

Reporting Investigator Information

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1533716
Name
Beschreibung

Investigator Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Title
Beschreibung

Clinical Investigators, Title

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C3888414
Speciality
Beschreibung

Clinical Investigators, Medical Specialities

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0037778
Address
Beschreibung

Clinical Investigators, Address

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1442065
City or State/Province
Beschreibung

Clinical Investigators, Cities, State/Province

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0008848
UMLS CUI [1,3]
C1547742
Country
Beschreibung

Clinical Investigators, Country

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0454664
Post or Zip Code
Beschreibung

Clinical Investigators, Postal Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1514254
Telephone No
Beschreibung

Clinical Investigators, Telephone Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1515258
Fax No
Beschreibung

Clinical Investigators, Fax Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1549619
Investigator's Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Investigator Signature, Date in time

Datentyp

date

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

nvestigator Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Pregnancy Notification Form (Subject's Partner)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Identification number, Randomization
Item
Randomization Number
integer
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item Group
Mother's Relevant Medical/Family History
C0032961 (UMLS CUI-1)
C0026591 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
Pregnancy, Mother, Date of birth
Item
Mother's date of birth
date
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0421451 (UMLS CUI [1,3])
Pregnancy, Mother, Date of last menstrual period
Item
Date of last menstrual period
date
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0425932 (UMLS CUI [1,3])
Pregnancy, Mother, Estimated date of delivery
Item
Estimated date of delivery
date
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C1287845 (UMLS CUI [1,3])
Pregnancy, Mother, Contraceptive method
Item
Was the mother using a method of contraception?
boolean
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Pregnancy, Mother, Contraceptive method
Item
ff Yes, specify
text
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Item
Type of conception, check one
text
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C2598844 (UMLS CUI [1,3])
Pregnancy, Mother, Type of Conception
Code List
Type of conception, check one
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilisation) (2)
Item
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
text
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C0199171 (UMLS CUI [1,4])
Pregnancy, Mother, Type of Conception
Code List
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Pregnancy, Mother, Number of Previous Pregnancies
Item
Number of previous pregnancies (specify: Pre-term, Full-term, Normal births, Stillbirths, Children born with defects, Spontaneous abortions, Elective abortions, Other)
text
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0422807 (UMLS CUI [1,3])
Pregnancy, Mother, Congenital Abnormality, number of children
Item
Record details of children born with defects
text
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,3])
C2229974 (UMLS CUI [1,4])
Pregnancy, Mother, Risk factors, Pregnancy Outcome
Item
Are there any additional factors that may have an impact on the outcome of this pregnancy?
boolean
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C0032972 (UMLS CUI [1,4])
Pregnancy, Mother, Risk factors, Pregnancy Outcome
Item
ff Yes, specify
boolean
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C0032972 (UMLS CUI [1,4])
Item Group
Father's Relevant Medical/Family History
C0032961 (UMLS CUI-1)
C0015671 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
Pregnancy, Father, Medical History
Item
Father's Relevant Medical/Family History (Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/ chromosomal disorders and medication use}
text
C0032961 (UMLS CUI [1,1])
C0015671 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Item Group
Drug Exposures
C0032961 (UMLS CUI-1)
C0743284 (UMLS CUI-2)
Drug exposure during pregnancy, Medication name
Item
Drug Name
text
C0877161 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Drug exposure during pregnancy, Drug Administration Routes
Item
Route of Administration or Formulation
text
C0877161 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Drug exposure during pregnancy, Daily Dose, Total
Item
Total Daily Dose
text
C0877161 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Drug exposure during pregnancy, Unit of Measure
Item
Units
text
C0877161 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Drug exposure during pregnancy, Start Date, Before, Clinical Trial Period
Item
Started Pre-Study
boolean
C0877161 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Drug exposure during pregnancy, Start Date
Item
Start Date
date
C0877161 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Drug exposure during pregnancy, End Date
Item
Stop Date
date
C0877161 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Drug exposure during pregnancy, Continuous
Item
Ongoing Medication
boolean
C0877161 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Drug exposure during pregnancy, Indication
Item
Reason for Medication
text
C0877161 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pregnancy, Withdraw
Item
Was the subject withdrawn from the study as a result of this pregnancy?
boolean
C0032961 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Item Group
Reporting Investigator Information
C0008961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Investigator Name
Item
Name
text
C2826892 (UMLS CUI [1])
Clinical Investigators, Title
Item
Title
text
C0008961 (UMLS CUI [1,1])
C3888414 (UMLS CUI [1,2])
Clinical Investigators, Medical Specialities
Item
Speciality
text
C0008961 (UMLS CUI [1,1])
C0037778 (UMLS CUI [1,2])
Clinical Investigators, Address
Item
Address
text
C0008961 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Clinical Investigators, Cities, State/Province
Item
City or State/Province
text
C0008961 (UMLS CUI [1,1])
C0008848 (UMLS CUI [1,2])
C1547742 (UMLS CUI [1,3])
Clinical Investigators, Country
Item
Country
text
C0008961 (UMLS CUI [1,1])
C0454664 (UMLS CUI [1,2])
Clinical Investigators, Postal Code
Item
Post or Zip Code
text
C0008961 (UMLS CUI [1,1])
C1514254 (UMLS CUI [1,2])
Clinical Investigators, Telephone Number
Item
Telephone No
integer
C0008961 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Clinical Investigators, Fax Number
Item
Fax No
integer
C0008961 (UMLS CUI [1,1])
C1549619 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
nvestigator Name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
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