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)
- 12/7/18 12/7/18 -
- 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
Pregnancy notification form (subject's partner)
- StudyEvent: ODM
Description
Mothers relevant medical/family history
Alias
- UMLS CUI-1
- C0026591
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0241889
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0421451
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0425932
Description
day month year
Data type
boolean
Alias
- UMLS CUI [1]
- C1287845
Description
Use of a method of contraception
Data type
text
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C0700589
Description
Method of contraception
Data type
text
Alias
- UMLS CUI [1]
- C0700589
Description
Tick one
Data type
integer
Alias
- UMLS CUI [1]
- C2598844
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
Description
Number of previous pregnancies
Alias
- UMLS CUI-1
- C0422807
Description
Number of Pre-term
Data type
integer
Alias
- UMLS CUI [1,1]
- C0151526
- UMLS CUI [1,2]
- C0449788
Description
Number of Full-term
Data type
integer
Alias
- UMLS CUI [1,1]
- C3814420
- UMLS CUI [1,2]
- C0449788
Description
If applicable, record the number in the appropriate categories
Data type
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Description
If applicable, record the number in the appropriate categories
Data type
integer
Alias
- UMLS CUI [1,1]
- C0595939
- UMLS CUI [1,2]
- C0449788
Description
If applicable, record the number in the appropriate categories
Data type
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C0449788
Description
If applicable, record the number in the appropriate categories
Data type
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Description
If applicable, record the number in the appropriate categories
Data type
integer
Alias
- UMLS CUI [1,1]
- C0269439
- UMLS CUI [1,2]
- C0449788
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
Description
Children born with defects
Data type
text
Alias
- UMLS CUI [1,1]
- C0008059
- UMLS CUI [1,2]
- C0000768
Description
Additional factors impacting outcome of pregnancy
Data type
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C0032972
Description
Specification of factors
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0035648
Description
Fathers relevant medical/family history
Alias
- UMLS CUI-1
- C0015671
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0241889
Description
DRUG EXPOSURES
Alias
- UMLS CUI-1
- C0743284
Description
(Trade Name preferred)
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Route of Administration or Formulation
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Total Daily Dose
Data type
integer
Alias
- UMLS CUI [1]
- C2348070
Description
Units of Total Daily Dose
Data type
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C1519795
Description
Started Pre-study
Data type
text
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Ongoing Medication
Data type
text
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Withdraw from study
Alias
- UMLS CUI-1
- C2349954
Description
REPORTING INVESTIGATOR INFORMATION
Alias
- UMLS CUI-1
- C1955348
- UMLS CUI-2
- C0008961
Description
Name of investigator
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Title of investigator
Data type
text
Alias
- UMLS CUI [1,1]
- C3888414
- UMLS CUI [1,2]
- C0008961
Description
Speciality of investigator
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0037778
Description
Address
Data type
text
Alias
- UMLS CUI [1]
- C1442065
Description
City or State/Province
Data type
text
Alias
- UMLS CUI [1,1]
- C0008848
- UMLS CUI [1,2]
- C1547742
Description
Country
Data type
text
Alias
- UMLS CUI [1]
- C0454664
Description
Post or Zip code
Data type
text
Alias
- UMLS CUI [1,1]
- C1514254
- UMLS CUI [1,2]
- C0600091
Description
Telephone No
Data type
integer
Alias
- UMLS CUI [1]
- C1515258
Description
Fax No
Data type
integer
Alias
- UMLS CUI [1]
- C1549619
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0807937
Description
Confirming that the data on these page are accurate and complete.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's name (print)
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Pregnancy notification form (subject's partner)
- StudyEvent: ODM
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
C0421451 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
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])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0000768 (UMLS CUI [1,2])
C0032972 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
C0241889 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0008961 (UMLS CUI-2)
C0008961 (UMLS CUI [1,2])
C0037778 (UMLS CUI [1,2])
C1547742 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
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