ID

34038

Beschreibung

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

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Versionen (2)
  1. 09.11.18 09.11.18 -
  2. 11.01.19 11.01.19 -
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GSK group of companies

Hochgeladen am

11. Januar 2019

DOI

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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

Englisch

Pregnancy Notification Form

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Beschreibung

Randomisation Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Pregnancy Notification Form (Subject)
Beschreibung

Pregnancy Notification Form (Subject)

Alias
UMLS CUI-1
C0032961
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
Beschreibung

This form does not routinely need to be completed for subject's partner pregnancy unless there is specific instruction to do so stated in the protocol.

Datentyp

text

Alias
UMLS CUI [1]
C0032961
Mother's Relevant Medical/Family History
Beschreibung

Mother's Relevant Medical/Family History

Alias
UMLS CUI-1
C0026591
UMLS CUI-2
C0262926
UMLS CUI-3
C0241889
Mother's date of birth
Beschreibung

Mother's date of birth

Datentyp

date

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

Date of last menstrual period

Datentyp

date

Alias
UMLS CUI [1]
C0425932
Estimated date of delivery
Beschreibung

Estimated date of delivery

Datentyp

date

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

Was the mother using a method of contraception?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0026591
If YES, specify
Beschreibung

If YES, specify

Datentyp

text

Alias
UMLS CUI [1]
C2348235
Type of conception, check one
Beschreibung

Type of conception, check one

Datentyp

text

Alias
UMLS CUI [1]
C2598844
Relevant laboratory tests and procedures
Beschreibung

e.g., ultrasound, aminiocentesis and chorionic villi sampling, including dates of tests and procedures

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Number of previous pregnancies pre-term
Beschreibung

Number of previous pregnancies pre-term

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C1547235
Number of previous pregnancies full-term
Beschreibung

Number of previous pregnancies full-term

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C1547235
If applicable, record the number in the appropriate categories below:
Beschreibung

If applicable, record the number in the appropriate categories below:

Alias
UMLS CUI-1
C0237753
Normal births
Beschreibung

Normal births

Datentyp

integer

Alias
UMLS CUI [1,1]
C3665337
UMLS CUI [1,2]
C0237753
Stillbirths
Beschreibung

Stillbirths

Datentyp

integer

Alias
UMLS CUI [1,1]
C0595939
UMLS CUI [1,2]
C0237753
Children born with defects
Beschreibung

Children born with defects

Datentyp

integer

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2229974
Spontaneous abortion
Beschreibung

Spontaneous abortion

Datentyp

integer

Alias
UMLS CUI [1,1]
C0000786
UMLS CUI [1,2]
C0237753
Elective abortion
Beschreibung

Elective abortion

Datentyp

integer

Alias
UMLS CUI [1,1]
C0269439
UMLS CUI [1,2]
C0237753
Other
Beschreibung

Other

Datentyp

integer

Alias
UMLS CUI [1]
C0205394
Record details of children born with defects
Beschreibung

Record details of children born with defects

Datentyp

text

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1522508
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032972
UMLS CUI [1,2]
C1521761
If YES, specify
Beschreibung

If YES, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0032972
UMLS CUI [1,2]
C1521761
UMLS CUI [1,3]
C2348235
Father's Relevant Medical/Family History
Beschreibung

Father's Relevant Medical/Family History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0241889
UMLS CUI-3
C0015671
Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects /genetic /chromosomal disorders and medication use
Beschreibung

Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects /genetic /chromosomal disorders and medication use

Datentyp

text

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0038586
UMLS CUI [2]
C0008679
UMLS CUI [3]
C0851352
UMLS CUI [4]
C0008625
UMLS CUI [5]
C0013227
Drug Exposures
Beschreibung

Drug Exposures

Alias
UMLS CUI-1
C0743284
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.
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2603343
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1522508
Drug Name
Beschreibung

Trade name preferred

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Route of Administration or Formulation
Beschreibung

Route of Administration or Formulation

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

float

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

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Started Pre-Study?
Beschreibung

Started Pre-Study?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Was the subject withdrawn from the study as a result of this pregnancy?
Beschreibung

Was the subject withdrawn from the study as a result of this pregnancy?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0032961
Reporting Investigator Information
Beschreibung

Reporting Investigator Information

Alias
UMLS CUI-1
C1955348
UMLS CUI-2
C0008961
Name
Beschreibung

Forward to a more appropriate physician if needed

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Title
Beschreibung

Title

Datentyp

text

Alias
UMLS CUI [1]
C3888414
Speciality
Beschreibung

Speciality

Datentyp

text

Alias
UMLS CUI [1]
C0037778
Address
Beschreibung

Address

Datentyp

text

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

City or State/Province

Datentyp

text

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

Country

Datentyp

text

Alias
UMLS CUI [1]
C0454664
Post or ZIP Code
Beschreibung

Post or ZIP Code

Datentyp

text

Alias
UMLS CUI [1]
C1514254
Telephone Number
Beschreibung

Telephone Number

Datentyp

integer

Alias
UMLS CUI [1]
C1515258
Fax Number
Beschreibung

Fax Number

Datentyp

integer

Alias
UMLS CUI [1]
C1549619
Investigator's signature
Beschreibung

confirming that the data on these pages are accurate and complete

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (Print)
Beschreibung

Investigator's name (Print)

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
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Ähnliche Modelle

Pregnancy Notification Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
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])
Item Group
Pregnancy Notification Form (Subject)
C0032961 (UMLS CUI-1)
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])
Item Group
Mother's Relevant Medical/Family History
C0026591 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
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])
Type of conception, check one
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])
Item Group
If applicable, record the number in the appropriate categories below:
C0237753 (UMLS CUI-1)
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])
Item Group
Father's Relevant Medical/Family History
C0262926 (UMLS CUI-1)
C0241889 (UMLS CUI-2)
C0015671 (UMLS CUI-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])
Item Group
Drug Exposures
C0743284 (UMLS CUI-1)
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])
Item Group
Reporting Investigator Information
C1955348 (UMLS CUI-1)
C0008961 (UMLS CUI-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])
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