ID
40854
Description
Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Pregnancy Notification Form is used to report pregnancy to GSK in specific cases specified by the Protocol. This form should be completed according to the protocol reporting requirements. Complete this form for each subject or 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.
Keywords
Versions (1)
- 5/26/20 5/26/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 26, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
Description
Mother's relevant medical/family history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0241889
- UMLS CUI-3
- C0026591
Description
Mother's date of birth
Data type
date
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0421451
Description
Date of last menstrual period
Data type
date
Alias
- UMLS CUI [1]
- C0425932
Description
Estimated date of delivery
Data type
date
Alias
- UMLS CUI [1]
- C1287845
Description
Contraceptive methods Mother
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0026591
Description
If Yes, specify:
Data type
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C2348235
Description
Type of conception, tick one:
Data type
text
Alias
- UMLS CUI [1]
- C2598844
Description
(e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Data type
text
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0430022
Description
Number of previous pregnancies: Pre-term
Data type
integer
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1547235
- UMLS CUI [1,3]
- C0449788
Description
Number of previous pragnancies: Full-term
Data type
integer
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C3814420
- UMLS CUI [1,3]
- C0449788
Description
If applicable, record the number.
Data type
integer
Alias
- UMLS CUI [1]
- C3665337
Description
If applicable, record the number
Data type
integer
Alias
- UMLS CUI [1]
- C0595939
Description
If applicable, record the number.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Description
Record details of children born with defects
Data type
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0000768
- UMLS CUI [1,3]
- C2229974
Description
If applicable, record the number.
Data type
integer
Alias
- UMLS CUI [1]
- C0000786
Description
If applicable, record the number.
Data type
integer
Alias
- UMLS CUI [1]
- C0269439
Description
If applicable, record the number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0156543
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0005615
Description
Pregnancy outcome Factors
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
Description
If Yes, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0032972
- UMLS CUI [1,3]
- C1521761
Description
Father's Relevant Medical/Family History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
- UMLS CUI-4
- C0241889
- UMLS CUI-5
- C0015671
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]
- C0015671
- UMLS CUI [2,1]
- C0241889
- UMLS CUI [2,2]
- C0015671
Description
Drug Exposures
Alias
- UMLS CUI-1
- C0743284
Description
Trade Name preferred
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Route of Admin. or Formulation
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Total Daily Dose
Data type
float
Alias
- UMLS CUI [1]
- C2348070
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Started Pre-Study
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0451613
Description
Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- 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
Subject withdrawal
Alias
- UMLS CUI-1
- C0422727
Description
Reporting Investigator Information
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Description
Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Title
Data type
text
Alias
- UMLS CUI [1,1]
- C3888414
- UMLS CUI [1,2]
- C0008961
Description
Speciality
Data type
text
Alias
- UMLS CUI [1,1]
- C0037778
- UMLS CUI [1,2]
- C0008961
Description
Address
Data type
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Description
City or State/Province
Data type
text
Alias
- UMLS CUI [1,1]
- C1555315
- UMLS CUI [1,2]
- C1301808
Description
Country
Data type
text
Alias
- UMLS CUI [1,1]
- C0454664
- UMLS CUI [1,2]
- C0008961
Description
Post or Zip Code
Data type
text
Alias
- UMLS CUI [1,1]
- C3166855
- UMLS CUI [1,2]
- C0008961
Description
Telephone No
Data type
text
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0008961
Description
Fax No
Data type
text
Alias
- UMLS CUI [1,1]
- C1549619
- UMLS CUI [1,2]
- C0008961
Description
(confirming that the data on these pages are accurate and complete)
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2346576
Description
Investigator's name (print)
Data type
text
Alias
- UMLS CUI [1]
- C2826892
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Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
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C0237753 (UMLS CUI [1,2])
C0241889 (UMLS CUI-2)
C0026591 (UMLS CUI-3)
C0421451 (UMLS CUI [1,2])
C0026591 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0430022 (UMLS CUI [2])
C1547235 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C3814420 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C2229974 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,2])
C2229974 (UMLS CUI [1,3])
C0156543 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C0005615 (UMLS CUI [2,2])
C1521761 (UMLS CUI [1,2])
C0032972 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,3])
C0015671 (UMLS CUI-2)
C0241889 (UMLS CUI-4)
C0015671 (UMLS CUI-5)
C0015671 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0015671 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C0008961 (UMLS CUI [1,2])
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