ID
40854
Beschrijving
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.
Trefwoorden
Versies (1)
- 26-05-20 26-05-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 mei 2020
DOI
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Licentie
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
Beschrijving
Mother's relevant medical/family history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0241889
- UMLS CUI-3
- C0026591
Beschrijving
Mother's date of birth
Datatype
date
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0421451
Beschrijving
Date of last menstrual period
Datatype
date
Alias
- UMLS CUI [1]
- C0425932
Beschrijving
Estimated date of delivery
Datatype
date
Alias
- UMLS CUI [1]
- C1287845
Beschrijving
Contraceptive methods Mother
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0026591
Beschrijving
If Yes, specify:
Datatype
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C2348235
Beschrijving
Type of conception, tick one:
Datatype
text
Alias
- UMLS CUI [1]
- C2598844
Beschrijving
(e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0430022
Beschrijving
Number of previous pregnancies: Pre-term
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1547235
- UMLS CUI [1,3]
- C0449788
Beschrijving
Number of previous pragnancies: Full-term
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C3814420
- UMLS CUI [1,3]
- C0449788
Beschrijving
If applicable, record the number.
Datatype
integer
Alias
- UMLS CUI [1]
- C3665337
Beschrijving
If applicable, record the number
Datatype
integer
Alias
- UMLS CUI [1]
- C0595939
Beschrijving
If applicable, record the number.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Beschrijving
Record details of children born with defects
Datatype
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0000768
- UMLS CUI [1,3]
- C2229974
Beschrijving
If applicable, record the number.
Datatype
integer
Alias
- UMLS CUI [1]
- C0000786
Beschrijving
If applicable, record the number.
Datatype
integer
Alias
- UMLS CUI [1]
- C0269439
Beschrijving
If applicable, record the number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0156543
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0005615
Beschrijving
Pregnancy outcome Factors
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
Beschrijving
If Yes, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0032972
- UMLS CUI [1,3]
- C1521761
Beschrijving
Father's Relevant Medical/Family History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
- UMLS CUI-4
- C0241889
- UMLS CUI-5
- C0015671
Beschrijving
Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/ chromosomal disorders and medication use
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015671
- UMLS CUI [2,1]
- C0241889
- UMLS CUI [2,2]
- C0015671
Beschrijving
Drug Exposures
Alias
- UMLS CUI-1
- C0743284
Beschrijving
Trade Name preferred
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Route of Admin. or Formulation
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Total Daily Dose
Datatype
float
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Started Pre-Study
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0451613
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Stop Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Ongoing Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
Subject withdrawal
Alias
- UMLS CUI-1
- C0422727
Beschrijving
Reporting Investigator Information
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Beschrijving
Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Title
Datatype
text
Alias
- UMLS CUI [1,1]
- C3888414
- UMLS CUI [1,2]
- C0008961
Beschrijving
Speciality
Datatype
text
Alias
- UMLS CUI [1,1]
- C0037778
- UMLS CUI [1,2]
- C0008961
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschrijving
City or State/Province
Datatype
text
Alias
- UMLS CUI [1,1]
- C1555315
- UMLS CUI [1,2]
- C1301808
Beschrijving
Country
Datatype
text
Alias
- UMLS CUI [1,1]
- C0454664
- UMLS CUI [1,2]
- C0008961
Beschrijving
Post or Zip Code
Datatype
text
Alias
- UMLS CUI [1,1]
- C3166855
- UMLS CUI [1,2]
- C0008961
Beschrijving
Telephone No
Datatype
text
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0008961
Beschrijving
Fax No
Datatype
text
Alias
- UMLS CUI [1,1]
- C1549619
- UMLS CUI [1,2]
- C0008961
Beschrijving
(confirming that the data on these pages are accurate and complete)
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2346576
Beschrijving
Investigator's name (print)
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
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])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C1301808 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])