ID
40801
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 Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis) Form has to be filled in at following visits: Screening, Treatment Period 1 Predose, Treatment Period 1 Prior to Discharge, Treatment Period 2 Predose, Treatment Period 2 Prior to Discharge, and whenever further assesments are done during the study (Unscheduled).
Trefwoorden
Versies (1)
- 15-05-20 15-05-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 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
Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis)
Beschrijving
Local Laboratory Result Data - [Clinical Chemistry]
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Beschrijving
Date and time sample taken - clinical chemistry
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0523961
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201975
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0555903
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201838
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201973
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0337438
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202194
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0337443
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201925
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201950
- UMLS CUI [1,2]
- C0005768
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202236
- UMLS CUI [1,2]
- C0005768
Beschrijving
Laboratory result data - [Haematology]
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschrijving
Date and time sample taken - haematology
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C0014772
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C1948043
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C1261502
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C0474535
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C0018935
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C0032181
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C0948762
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C3544087
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C0200637
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C0200638
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0584609
- UMLS CUI [1,2]
- C0549177
- UMLS CUI [1,3]
- C0007584
Beschrijving
Urinalysis (Dipstick) Test
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Beschrijving
Date and time sample taken - Urinalysis
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Beschrijving
Protein Urine
Datatype
text
Alias
- UMLS CUI [1]
- C0262923
Beschrijving
Glucose Urine
Datatype
text
Alias
- UMLS CUI [1]
- C0004076
Beschrijving
Ketones Urine
Datatype
text
Alias
- UMLS CUI [1,1]
- C1991100
- UMLS CUI [1,2]
- C0430370
Beschrijving
Nitrates Urine
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0028125
Beschrijving
Bilirubin Urine
Datatype
text
Alias
- UMLS CUI [1]
- C0042040
Beschrijving
Blood Urine
Datatype
text
Alias
- UMLS CUI [1]
- C0430372
Beschrijving
Urobilinogen Urine
Datatype
text
Alias
- UMLS CUI [1]
- C0427736
Beschrijving
Leucocytes Urine
Datatype
text
Alias
- UMLS CUI [1]
- C1256582
Beschrijving
Urinalysis (Microscopy) Test
Alias
- UMLS CUI-1
- C0430397
Beschrijving
Sedimentary microscopy should only be performed if the dipstick result for protein, nitrates, blood or leucocytes is abnormal.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Beschrijving
Urinalysis Microscopy - White blood cells
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0023508
Beschrijving
Urinalysis Microscopy - Red blood cells
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0014772
Beschrijving
Urinalysis Microspocy - Hyaline casts
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C1254537
Beschrijving
Urinalysis Microscopy - Granular casts
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2697521
Beschrijving
Urinalysis Microscopy - Cellular casts
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2699157
Similar models
Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis)
C0008000 (UMLS CUI-2)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0549177 (UMLS CUI [1,2])
C0007584 (UMLS CUI [1,3])
C0430370 (UMLS CUI-2)
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0430370 (UMLS CUI [1,2])
C0028125 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
C0023508 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,2])
C1254537 (UMLS CUI [1,2])
C2697521 (UMLS CUI [1,2])
C2699157 (UMLS CUI [1,2])