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