ID
40854
Beschreibung
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.
Stichworte
Versionen (1)
- 26.05.20 26.05.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
26. Mai 2020
DOI
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Lizenz
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
Beschreibung
Mother's relevant medical/family history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0241889
- UMLS CUI-3
- C0026591
Beschreibung
Mother's date of birth
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0421451
Beschreibung
Date of last menstrual period
Datentyp
date
Alias
- UMLS CUI [1]
- C0425932
Beschreibung
Estimated date of delivery
Datentyp
date
Alias
- UMLS CUI [1]
- C1287845
Beschreibung
Contraceptive methods Mother
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0026591
Beschreibung
If Yes, specify:
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C2348235
Beschreibung
Type of conception, tick one:
Datentyp
text
Alias
- UMLS CUI [1]
- C2598844
Beschreibung
(e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Datentyp
text
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0430022
Beschreibung
Number of previous pregnancies: Pre-term
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1547235
- UMLS CUI [1,3]
- C0449788
Beschreibung
Number of previous pragnancies: Full-term
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C3814420
- UMLS CUI [1,3]
- C0449788
Beschreibung
If applicable, record the number.
Datentyp
integer
Alias
- UMLS CUI [1]
- C3665337
Beschreibung
If applicable, record the number
Datentyp
integer
Alias
- UMLS CUI [1]
- C0595939
Beschreibung
If applicable, record the number.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Beschreibung
Record details of children born with defects
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0000768
- UMLS CUI [1,3]
- C2229974
Beschreibung
If applicable, record the number.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0000786
Beschreibung
If applicable, record the number.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0269439
Beschreibung
If applicable, record the number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0156543
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0005615
Beschreibung
Pregnancy outcome Factors
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
Beschreibung
If Yes, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0032972
- UMLS CUI [1,3]
- C1521761
Beschreibung
Father's Relevant Medical/Family History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
- UMLS CUI-4
- C0241889
- UMLS CUI-5
- C0015671
Beschreibung
Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/ chromosomal disorders and medication use
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015671
- UMLS CUI [2,1]
- C0241889
- UMLS CUI [2,2]
- C0015671
Beschreibung
Drug Exposures
Alias
- UMLS CUI-1
- C0743284
Beschreibung
Trade Name preferred
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Route of Admin. or Formulation
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Total Daily Dose
Datentyp
float
Alias
- UMLS CUI [1]
- C2348070
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Started Pre-Study
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0451613
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschreibung
Ongoing Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
Subject withdrawal
Alias
- UMLS CUI-1
- C0422727
Beschreibung
Reporting Investigator Information
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Beschreibung
Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Title
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3888414
- UMLS CUI [1,2]
- C0008961
Beschreibung
Speciality
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0037778
- UMLS CUI [1,2]
- C0008961
Beschreibung
Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschreibung
City or State/Province
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1555315
- UMLS CUI [1,2]
- C1301808
Beschreibung
Country
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0454664
- UMLS CUI [1,2]
- C0008961
Beschreibung
Post or Zip Code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3166855
- UMLS CUI [1,2]
- C0008961
Beschreibung
Telephone No
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0008961
Beschreibung
Fax No
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1549619
- UMLS CUI [1,2]
- C0008961
Beschreibung
(confirming that the data on these pages are accurate and complete)
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2346576
Beschreibung
Investigator's name (print)
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Ähnliche Modelle
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])