ID

23039

Beskrivning

NCT00340080 / VIIV-CNA106030 https://clinicaltrials.gov/ct2/show/NCT00340080 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Pregnancy Notification Form Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Länk

https://clinicaltrials.gov/ct2/show/NCT00340080

Nyckelord

Versioner (2)
  1. 2017-06-20 2017-06-20 -
  2. 2017-06-20 2017-06-20 -
Uppladdad den

20 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Genetic Screening For HLA-B*5701 Pregnancy Notification Form NCT00340080

Engelsk

Genetic Screening For HLA-B*5701 Pregnancy Notification Form NCT00340080

1 Formulär  
Pregnancy Notification Form
Beskrivning

Pregnancy Notification Form

Alias
UMLS CUI-1
C0032961
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Mothers date of birth
Beskrivning

Mothers date of birth

Datatyp

date

Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0421451
Date of last menstrual period
Beskrivning

Date of last menstrual period

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0025329
Estimated date of delivery
Beskrivning

Estimated date of delivery

Datatyp

date

Alias
UMLS CUI [1]
C1287845
Was the mother using a method of contraception?
Beskrivning

contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
If Yes, please specify
Beskrivning

Was the mother using a method of contraception?

Datatyp

text

Alias
UMLS CUI [1]
C0700589
Type of conception, check one:
Beskrivning

Type of conception

Datatyp

integer

Alias
UMLS CUI [1]
C2598844
Relevant laboratory tests
Beskrivning

Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).

Datatyp

text

Alias
UMLS CUI [1]
C0022885
laboratory test date
Beskrivning

Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).

Datatyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Relevant procedures
Beskrivning

Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).

Datatyp

text

Alias
UMLS CUI [1]
C0430022
procedure date
Beskrivning

Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).

Datatyp

date

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0011008
Number of previous pregnancies: Pre-term
Beskrivning

Pre-term pregnancies

Datatyp

integer

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1547235
UMLS CUI [1,3]
C0449788
Number of previous pregnancies: Full-term
Beskrivning

Full-term pregnancy

Datatyp

integer

Alias
UMLS CUI [1,1]
C2114495
UMLS CUI [1,2]
C0449788
Number of: Normal births
Beskrivning

Normal births

Datatyp

integer

Alias
UMLS CUI [1,1]
C3665337
UMLS CUI [1,2]
C0449788
Number of: Stillbirths
Beskrivning

Stillbirths

Datatyp

integer

Alias
UMLS CUI [1,1]
C0595939
UMLS CUI [1,2]
C0449788
Number of: Children born with defects
Beskrivning

Children born with defects

Datatyp

integer

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0449788
Record details of children born with defects
Beskrivning

Children born with defects

Datatyp

text

Alias
UMLS CUI [1]
C0000768
Number of: Spontaneous abortion
Beskrivning

Spontaneous abortion

Datatyp

integer

Alias
UMLS CUI [1,1]
C0000786
UMLS CUI [1,2]
C0449788
Number of: Elective abortion
Beskrivning

Elective abortion

Datatyp

integer

Alias
UMLS CUI [1,1]
C0269439
UMLS CUI [1,2]
C0449788
Number of: Other
Beskrivning

other birth

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005615
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0449788
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Beskrivning

impact on the outcome of this pregnancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032972
UMLS CUI [1,2]
C1521761
If Yes, please specify
Beskrivning

Are there any additional factors that may have an impact on the outcome of this pregnancy?

Datatyp

text

Alias
UMLS CUI [1,1]
C0032972
UMLS CUI [1,2]
C1521761
Fathers relevant medical/family history
Beskrivning

Fathers relevant medical/family history

Datatyp

text

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C0241889
Was the subject withdrawn from the study as a result of this pregnancy?
Beskrivning

withdrawn from the study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0032961
Drug exposures
Beskrivning

Drug exposures

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

Drug Name

Datatyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0013227
Route of Admin. or Formulation
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dose
Beskrivning

Total Daily Dose

Datatyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0013227
Started Pre-Study
Beskrivning

Started Pre-Study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0451613
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Stop Date
Beskrivning

Stop Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Ongoing Medication
Beskrivning

Ongoing Medication

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Tillbaka till toppen

Similar models

Genetic Screening For HLA-B*5701 Pregnancy Notification Form NCT00340080

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Pregnancy Notification Form
C0032961 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Mothers date of birth
Item
Mothers date of birth
date
C0026591 (UMLS CUI [1,1])
C0421451 (UMLS CUI [1,2])
Date of last menstrual period
Item
Date of last menstrual period
date
C0011008 (UMLS CUI [1,1])
C0025329 (UMLS CUI [1,2])
Estimated date of delivery
Item
Estimated date of delivery
date
C1287845 (UMLS CUI [1])
contraception
Item
Was the mother using a method of contraception?
boolean
C0700589 (UMLS CUI [1])
contraception
Item
If Yes, please specify
text
C0700589 (UMLS CUI [1])
Item
Type of conception, check one:
integer
C2598844 (UMLS CUI [1])
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)
laboratory tests
Item
Relevant laboratory tests
text
C0022885 (UMLS CUI [1])
laboratory test date
Item
laboratory test date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
procedure
Item
Relevant procedures
text
C0430022 (UMLS CUI [1])
procedure date
Item
procedure date
date
C0430022 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pre-term pregnancies
Item
Number of previous pregnancies: Pre-term
integer
C0032961 (UMLS CUI [1,1])
C1547235 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Full-term pregnancy
Item
Number of previous pregnancies: Full-term
integer
C2114495 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Normal births
Item
Number of: Normal births
integer
C3665337 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Stillbirths
Item
Number of: Stillbirths
integer
C0595939 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Children born with defects
Item
Number of: Children born with defects
integer
C0000768 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Children born with defects
Item
Record details of children born with defects
text
C0000768 (UMLS CUI [1])
Spontaneous abortion
Item
Number of: Spontaneous abortion
integer
C0000786 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Elective abortion
Item
Number of: Elective abortion
integer
C0269439 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
other birth
Item
Number of: Other
integer
C0005615 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
impact on the outcome of this pregnancy
Item
Are there any additional factors that may have an impact on the outcome of this pregnancy?
boolean
C0032972 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
impact on the outcome of this pregnancy
Item
If Yes, please specify
text
C0032972 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
Fathers relevant medical/family history
Item
Fathers relevant medical/family history
text
C0015671 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2])
withdrawn from the study
Item
Was the subject withdrawn from the study as a result of this pregnancy?
boolean
C0422727 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
Item Group
Drug exposures
C0743284 (UMLS CUI-1)
C0032961 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Route
Item
Route of Admin. or Formulation
text
C0013153 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Units
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Started Pre-Study
Item
Started Pre-Study
boolean
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Ongoing Medication
Item
Ongoing Medication
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Tillbaka till toppen 

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