ID

33375

Description

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the Pregnancy notification form (subject's partner). Complete this form for each subject's partner who becomes pregnant during the study period. This form should be completed according to the protocol reporting requirements. Complete this form for each subject's partner who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject's Case Report Form. Note: 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.

Link

https://clinicaltrials.gov/ct2/show/NCT00599612

Keywords

Versions (2)
  1. 12/7/18 12/7/18 -
  2. 12/7/18 12/7/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 7, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

English

Pregnancy notification form (subject's partner)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Mothers relevant medical/family history
Description

Mothers relevant medical/family history

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

day month year

Data type

date

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

day month year

Data type

date

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

day month year

Data type

boolean

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

Use of a method of contraception

Data type

text

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
If "useof a method of contraception", please specify
Description

Method of contraception

Data type

text

Alias
UMLS CUI [1]
C0700589
Type of conception
Description

Tick one

Data type

integer

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

(e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures). Please note for each date of test and procedure.

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C0011008
UMLS CUI [3]
C0041618
UMLS CUI [4,1]
C0002627
UMLS CUI [4,2]
C0870078
UMLS CUI [5]
C0008509
Number of previous pregnancies
Description

Number of previous pregnancies

Alias
UMLS CUI-1
C0422807
Number of Pre-term
Description

Number of Pre-term

Data type

integer

Alias
UMLS CUI [1,1]
C0151526
UMLS CUI [1,2]
C0449788
Number of Full-term
Description

Number of Full-term

Data type

integer

Alias
UMLS CUI [1,1]
C3814420
UMLS CUI [1,2]
C0449788
Number of Normal births
Description

If applicable, record the number in the appropriate categories

Data type

integer

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

If applicable, record the number in the appropriate categories

Data type

integer

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

If applicable, record the number in the appropriate categories

Data type

integer

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0449788
Number of Spontaneous abortion
Description

If applicable, record the number in the appropriate categories

Data type

integer

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

If applicable, record the number in the appropriate categories

Data type

integer

Alias
UMLS CUI [1,1]
C0269439
UMLS CUI [1,2]
C0449788
Number of Other birth types
Description

Number of Other birth types

Data type

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0449788
If children born with defects, please record details
Description

Children born with defects

Data type

text

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0000768
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Description

Additional factors impacting outcome of pregnancy

Data type

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0032972
If you tick yes for "additional factors", please specify
Description

Specification of factors

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0035648
Fathers relevant medical/family history
Description

Fathers relevant medical/family history

Alias
UMLS CUI-1
C0015671
UMLS CUI-2
C0262926
UMLS CUI-3
C0241889
Medical/family history
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0241889
DRUG EXPOSURES
Description

DRUG EXPOSURES

Alias
UMLS CUI-1
C0743284
Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C2360065
Route of Administration or Formulation
Description

Route of Administration or Formulation

Data type

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dose
Description

Total Daily Dose

Data type

integer

Alias
UMLS CUI [1]
C2348070
Units of Total Daily Dose
Description

Units of Total Daily Dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C1519795
Started Pre-study
Description

Started Pre-study

Data type

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Start date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication
Description

Ongoing Medication

Data type

text

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Withdraw from study
Description

Withdraw from study

Alias
UMLS CUI-1
C2349954
Was the subject withdrawn from the study as a result of this pregnancy?
Description

Withdraw

Data type

text

Alias
UMLS CUI [1]
C2349954
REPORTING INVESTIGATOR INFORMATION
Description

REPORTING INVESTIGATOR INFORMATION

Alias
UMLS CUI-1
C1955348
UMLS CUI-2
C0008961
Name of investigator
Description

Name of investigator

Data type

text

Alias
UMLS CUI [1]
C2826892
Title of investigator
Description

Title of investigator

Data type

text

Alias
UMLS CUI [1,1]
C3888414
UMLS CUI [1,2]
C0008961
Speciality of investigator
Description

Speciality of investigator

Data type

text

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

Address

Data type

text

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

City or State/Province

Data type

text

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

Country

Data type

text

Alias
UMLS CUI [1]
C0454664
Post or Zip code
Description

Post or Zip code

Data type

text

Alias
UMLS CUI [1,1]
C1514254
UMLS CUI [1,2]
C0600091
Telephone No
Description

Telephone No

Data type

integer

Alias
UMLS CUI [1]
C1515258
Fax No
Description

Fax No

Data type

integer

Alias
UMLS CUI [1]
C1549619
Date of signature
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0807937
Investigator's signature
Description

Confirming that the data on these page are accurate and complete.

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Description

Investigator's name (print)

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Pregnancy notification form (subject's partner)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item Group
Mothers 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
boolean
C1287845 (UMLS CUI [1])
Item
Was the mother using a method of contraception?
text
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Use of a method of contraception
Code List
Was the mother using a method of contraception?
CL Item
Yes (Y)
CL Item
No (N)
Method of contraception
Item
If "useof a method of contraception", please specify
text
C0700589 (UMLS CUI [1])
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
Item
Relevant laboratory tests and procedures
text
C0022885 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0041618 (UMLS CUI [3])
C0002627 (UMLS CUI [4,1])
C0870078 (UMLS CUI [4,2])
C0008509 (UMLS CUI [5])
Item Group
Number of previous pregnancies
C0422807 (UMLS CUI-1)
Number of Pre-term
Item
Number of Pre-term
integer
C0151526 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Full-term
Item
Number of Full-term
integer
C3814420 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Normal births
Item
Number of Normal births
integer
C3665337 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Stillbirths
Item
Number of Stillbirths
integer
C0595939 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Children born with defects
Item
Number of Children born with defects
integer
C0000768 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Spontaneous abortion
Item
Number of Spontaneous abortion
integer
C0000786 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Elective abortion
Item
Number of Elective abortion
integer
C0269439 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Other birth types
Item
Number of Other birth types
integer
C0205394 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Children born with defects
Item
If children born with defects, please record details
text
C0008059 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Item
Are there any additional factors that may have an impact on the outcome of this pregnancy?
text
C0035648 (UMLS CUI [1,1])
C0032972 (UMLS CUI [1,2])
Additional factors impacting outcome of pregnancy
Code List
Are there any additional factors that may have an impact on the outcome of this pregnancy?
CL Item
Yes (Y)
CL Item
No (N)
Specification of factors
Item
If you tick yes for "additional factors", please specify
text
C2348235 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
Item Group
Fathers relevant medical/family history
C0015671 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
Medical/family history
Item
Medical/family history
text
C0262926 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
Item Group
DRUG EXPOSURES
C0743284 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (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
integer
C2348070 (UMLS CUI [1])
Units of Total Daily Dose
Item
Units of Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Item
Started Pre-study
text
C0808070 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Started Pre-study
Code List
Started Pre-study
CL Item
Yes (Y)
CL Item
No (N)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1])
Item
Ongoing Medication
text
C2826666 (UMLS CUI [1])
Ongoing Medication
Code List
Ongoing Medication
CL Item
Yes (Y)
CL Item
No (N)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Withdraw from study
C2349954 (UMLS CUI-1)
Item
Was the subject withdrawn from the study as a result of this pregnancy?
text
C2349954 (UMLS CUI [1])
Withdraw
Code List
Was the subject withdrawn from the study as a result of this pregnancy?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
REPORTING INVESTIGATOR INFORMATION
C1955348 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
Name of investigator
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Title of investigator
Item
Title of investigator
text
C3888414 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Speciality of investigator
Item
Speciality of investigator
text
C0008961 (UMLS CUI [1,1])
C0037778 (UMLS CUI [1,2])
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])
Date of signature
Item
Date of signature
date
C0807937 (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])
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