ID

40996

Beschreibung

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

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  1. 09.06.20 09.06.20 -
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GlaxoSmithKline

Hochgeladen am

9. Juni 2020

DOI

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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447

Englisch

Pregnancy Notification Form (Subject's Partner)

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

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

Randomisation Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Pregnancy Notification Form - Mother's relevant medical/ family history
Beschreibung

Pregnancy Notification Form - Mother's relevant medical/ family history

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C0026591
UMLS CUI-3
C0262926
UMLS CUI-4
C0241889
Mother’s date of birth
Beschreibung

Mother’s date of birth

Datentyp

date

Alias
UMLS CUI [1,1]
C0421451
UMLS CUI [1,2]
C0026591
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]
C0026591
UMLS CUI [1,2]
C0700589
If the mother was using a method of contraception, specify
Beschreibung

If the mother was using a method of contraception, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C2348235
Type of conception
Beschreibung

Check one

Datentyp

integer

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

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

Datentyp

text

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C1456803
UMLS CUI [3]
C0002627
UMLS CUI [4]
C0008509
UMLS CUI [5]
C0011008
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]
C3814420
Number of previous pregnancies - Normal births
Beschreibung

Number of previous pregnancies - Normal births

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C3665337
Number of previous pregnancies - Stillbirths
Beschreibung

Number of previous pregnancies - Stillbirths

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C0595939
Number of previous pregnancies - Children with birth defects
Beschreibung

Number of previous pregnancies - Children with birth defects

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C0000768
Number of previous pregnancies - Spontaneous abortion
Beschreibung

Number of previous pregnancies - Spontaneous abortion

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C0000786
Number of previous pregnancies - Elective abortion
Beschreibung

Number of previous pregnancies - Elective abortion

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C0269439
Number of previous pregnancies - Other
Beschreibung

Number of previous pregnancies - Other

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C0205394
Record details of children born with defects
Beschreibung

Record details of children born with defects

Datentyp

text

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

If there are any additional factors that may have an impact on the outcome of this pregnancy, specify.

Datentyp

text

Alias
UMLS CUI [1,1]
C0032972
UMLS CUI [1,2]
C1521761
UMLS CUI [1,3]
C2348235
Pregnancy Notification Form - Father's relevant medical/ family history
Beschreibung

Pregnancy Notification Form - Father's relevant medical/ family history

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C0015671
UMLS CUI-3
C0262926
UMLS CUI-4
C0241889
Pregnancy Notification Form - Father's relevant medical/ family history
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]
C0032961
UMLS CUI [1,2]
C0015671
UMLS CUI [1,3]
C0262926
UMLS CUI [1,4]
C0241889
Pregnancy Notification Form - Drug Exposures
Beschreibung

Pregnancy Notification Form - Drug Exposures

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C0743284
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
UMLS CUI [2]
C1705957
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

float

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

Medication Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Medication started pre-study
Beschreibung

Medication started pre-study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C2347804
Medication start date
Beschreibung

Medication start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication stop date
Beschreibung

Medication stop date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Ongoing medication
Beschreibung

Ongoing medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
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]
C0422727
Reporting Investigator Information
Beschreibung

Reporting Investigator Information

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

Name

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 [1,1]
C1514254
UMLS CUI [1,2]
C0600091
Telephone No
Beschreibung

Telephone No

Datentyp

integer

Alias
UMLS CUI [1]
C1515258
Fax No
Beschreibung

Fax No

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 signature Date
Beschreibung

Investigator’s signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator’s name
Beschreibung

Investigator’s 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
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Pregnancy Notification Form - Mother's relevant medical/ family history
C0032961 (UMLS CUI-1)
C0026591 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0241889 (UMLS CUI-4)
Mother’s date of birth
Item
Mother’s date of birth
date
C0421451 (UMLS CUI [1,1])
C0026591 (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
C0026591 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
If the mother was using a method of contraception, specify
Item
If the mother was using a method of contraception, specify
text
C0026591 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Type of conception
integer
C2598844 (UMLS CUI [1])
Type of conception
Code List
Type of conception
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilisation) (2)
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Item
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
text
C0022885 (UMLS CUI [1])
C1456803 (UMLS CUI [2])
C0002627 (UMLS CUI [3])
C0008509 (UMLS CUI [4])
C0011008 (UMLS CUI [5])
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])
C3814420 (UMLS CUI [1,2])
Number of previous pregnancies - Normal births
Item
Number of previous pregnancies - Normal births
integer
C0422807 (UMLS CUI [1,1])
C3665337 (UMLS CUI [1,2])
Number of previous pregnancies - Stillbirths
Item
Number of previous pregnancies - Stillbirths
integer
C0422807 (UMLS CUI [1,1])
C0595939 (UMLS CUI [1,2])
Number of previous pregnancies - Children with birth defects
Item
Number of previous pregnancies - Children with birth defects
integer
C0422807 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Number of previous pregnancies - Spontaneous abortion
Item
Number of previous pregnancies - Spontaneous abortion
integer
C0422807 (UMLS CUI [1,1])
C0000786 (UMLS CUI [1,2])
Number of previous pregnancies - Elective abortion
Item
Number of previous pregnancies - Elective abortion
integer
C0422807 (UMLS CUI [1,1])
C0269439 (UMLS CUI [1,2])
Number of previous pregnancies - Other
Item
Number of previous pregnancies - Other
integer
C0422807 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Record details of children born with defects
Item
Record details of children born with defects
text
C1522508 (UMLS CUI [1,1])
C0000768 (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 there are any additional factors that may have an impact on the outcome of this pregnancy, specify.
Item
If there are any additional factors that may have an impact on the outcome of this pregnancy, specify.
text
C0032972 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Pregnancy Notification Form - Father's relevant medical/ family history
C0032961 (UMLS CUI-1)
C0015671 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0241889 (UMLS CUI-4)
Pregnancy Notification Form - Father's relevant medical/ family history
Item
Pregnancy Notification Form - Father's relevant medical/ family history
text
C0032961 (UMLS CUI [1,1])
C0015671 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,4])
Item Group
Pregnancy Notification Form - Drug Exposures
C0032961 (UMLS CUI-1)
C0743284 (UMLS CUI-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])
C1705957 (UMLS CUI [2])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Medication Units
Item
Medication Units
text
C1519795 (UMLS CUI [1])
Medication started pre-study
Item
Medication started pre-study
boolean
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
Medication start date
Item
Medication start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication stop date
Item
Medication 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])
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])
Item Group
Reporting Investigator Information
C0008961 (UMLS CUI-1)
C1533716 (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 [1,1])
C0600091 (UMLS CUI [1,2])
Telephone No
Item
Telephone No
integer
C1515258 (UMLS CUI [1])
Fax No
Item
Fax No
integer
C1549619 (UMLS CUI [1])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator’s signature Date
Item
Investigator’s signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator’s name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
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