Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Complete this form for each subject who becomes pregnant during the study period. Send a copy of the form to GSK by mail or fax within two weeks of learning of the pregnancy. Ensure the relevan information in the electronic Case Report Form is updated
Item
Complete this form for each subject who becomes pregnant during the study period. Send a copy of the form to GSK by mail or fax within two weeks of learning of the pregnancy. Ensure the relevan information in the electronic Case Report Form is updated
text
C0032961 (UMLS CUI [1])
Mother's date of birth
Item
Mother's 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
C0425932 (UMLS CUI [1])
Estimated date of delivery
Item
Estimated date of delivery
date
C1287845 (UMLS CUI [1])
Was the mother using a method of contraception?
Item
Was the mother using a method of contraception?
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0026591 (UMLS CUI [1,3])
If YES, specify
Item
If YES, specify
text
C2348235 (UMLS CUI [1])
Item
Type of conception, check one
text
C2598844 (UMLS CUI [1])
Code List
Type of conception, check one
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilisation) (2)
Relevant laboratory tests and procedures
Item
Relevant laboratory tests and procedures
text
C0022885 (UMLS CUI [1])
Number of previous pregnancies pre-term
Item
Number of previous pregnancies pre-term
integer
C0422807 (UMLS CUI [1,1])
C1547235 (UMLS CUI [1,2])
Number of previous pregnancies full-term
Item
Number of previous pregnancies full-term
integer
C0422807 (UMLS CUI [1,1])
C1547235 (UMLS CUI [1,2])
Normal births
Item
Normal births
integer
C3665337 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Stillbirths
Item
Stillbirths
integer
C0595939 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Children born with defects
Item
Children born with defects
integer
C0000768 (UMLS CUI [1,1])
C2229974 (UMLS CUI [1,2])
Spontaneous abortion
Item
Spontaneous abortion
integer
C0000786 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Elective abortion
Item
Elective abortion
integer
C0269439 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Other
Item
Other
integer
C0205394 (UMLS CUI [1])
Record details of children born with defects
Item
Record details of children born with defects
text
C0000768 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Are there any additional factors that may have an 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])
If YES, specify
Item
If YES, specify
text
C0032972 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects /genetic /chromosomal disorders and medication use
Item
Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects /genetic /chromosomal disorders and medication use
text
C0085762 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
C0851352 (UMLS CUI [3])
C0008625 (UMLS CUI [4])
C0013227 (UMLS CUI [5])
List all medications (including study medications) the subject received during the study period. Enter the investigational product details on the first line. If there are extensive concomitant medications, attach a copy of the concomitant Medications CRF screen.
Item
List all medications (including study medications) the subject received during the study period. Enter the investigational product details on the first line. If there are extensive concomitant medications, attach a copy of the concomitant Medications CRF screen.
text
C0013227 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C1522508 (UMLS CUI [2,2])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Route of Administration or Formulation
Item
Route of Administration or Formulation
text
C0013153 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Started Pre-Study?
Item
Started Pre-Study?
boolean
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Was the subject withdrawn from the study as a result of this pregnancy?
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])
Name
Item
Name
text
C2826892 (UMLS CUI [1])
Title
Item
Title
text
C3888414 (UMLS CUI [1])
Speciality
Item
Speciality
text
C0037778 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1])
City or State/Province
Item
City or State/Province
text
C0008848 (UMLS CUI [1,1])
C1547742 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Post or ZIP Code
Item
Post or ZIP Code
text
C1514254 (UMLS CUI [1])
Telephone Number
Item
Telephone Number
integer
C1515258 (UMLS CUI [1])
Fax Number
Item
Fax Number
integer
C1549619 (UMLS CUI [1])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name (Print)
Item
Investigator's name (Print)
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])