ID
40854
Beskrivning
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.
Nyckelord
Versioner (1)
- 2020-05-26 2020-05-26 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
26 maj 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
Beskrivning
Mother's relevant medical/family history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0241889
- UMLS CUI-3
- C0026591
Beskrivning
Mother's date of birth
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0421451
Beskrivning
Date of last menstrual period
Datatyp
date
Alias
- UMLS CUI [1]
- C0425932
Beskrivning
Estimated date of delivery
Datatyp
date
Alias
- UMLS CUI [1]
- C1287845
Beskrivning
Contraceptive methods Mother
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0026591
Beskrivning
If Yes, specify:
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C2348235
Beskrivning
Type of conception, tick one:
Datatyp
text
Alias
- UMLS CUI [1]
- C2598844
Beskrivning
(e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0430022
Beskrivning
Number of previous pregnancies: Pre-term
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1547235
- UMLS CUI [1,3]
- C0449788
Beskrivning
Number of previous pragnancies: Full-term
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C3814420
- UMLS CUI [1,3]
- C0449788
Beskrivning
If applicable, record the number.
Datatyp
integer
Alias
- UMLS CUI [1]
- C3665337
Beskrivning
If applicable, record the number
Datatyp
integer
Alias
- UMLS CUI [1]
- C0595939
Beskrivning
If applicable, record the number.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Beskrivning
Record details of children born with defects
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0000768
- UMLS CUI [1,3]
- C2229974
Beskrivning
If applicable, record the number.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0000786
Beskrivning
If applicable, record the number.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0269439
Beskrivning
If applicable, record the number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0156543
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0005615
Beskrivning
Pregnancy outcome Factors
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
Beskrivning
If Yes, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0032972
- UMLS CUI [1,3]
- C1521761
Beskrivning
Father's Relevant Medical/Family History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
- UMLS CUI-4
- C0241889
- UMLS CUI-5
- C0015671
Beskrivning
Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/ chromosomal disorders and medication use
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015671
- UMLS CUI [2,1]
- C0241889
- UMLS CUI [2,2]
- C0015671
Beskrivning
Drug Exposures
Alias
- UMLS CUI-1
- C0743284
Beskrivning
Trade Name preferred
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Route of Admin. or Formulation
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Total Daily Dose
Datatyp
float
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Started Pre-Study
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0451613
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Stop Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
Ongoing Medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
Subject withdrawal
Alias
- UMLS CUI-1
- C0422727
Beskrivning
Reporting Investigator Information
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Beskrivning
Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Title
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3888414
- UMLS CUI [1,2]
- C0008961
Beskrivning
Speciality
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037778
- UMLS CUI [1,2]
- C0008961
Beskrivning
Address
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beskrivning
City or State/Province
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1555315
- UMLS CUI [1,2]
- C1301808
Beskrivning
Country
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0454664
- UMLS CUI [1,2]
- C0008961
Beskrivning
Post or Zip Code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3166855
- UMLS CUI [1,2]
- C0008961
Beskrivning
Telephone No
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0008961
Beskrivning
Fax No
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1549619
- UMLS CUI [1,2]
- C0008961
Beskrivning
(confirming that the data on these pages are accurate and complete)
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2346576
Beskrivning
Investigator's name (print)
Datatyp
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])