ID
40933
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 12-Lead ECG Abnormalities Form has to be filled in whenever an abnormal ECG curve is recorded durig the study.
Trefwoorden
Versies (1)
- 07-06-20 07-06-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
7 juni 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
12-Lead ECG Abnormalities
- StudyEvent: ODM
Beschrijving
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beschrijving
Rhythm
Alias
- UMLS CUI-1
- C0232187
Beschrijving
[A1]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
[A21]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschrijving
[A22]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschrijving
[A23]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschrijving
[A3]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschrijving
[A2]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Beschrijving
[A4]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschrijving
[A20]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschrijving
[A17]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschrijving
[A26]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C0018810
Beschrijving
[A6]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Beschrijving
[A7]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschrijving
[A8]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschrijving
[A5]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Beschrijving
[A25]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschrijving
[A24]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Beschrijving
[A9]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschrijving
[A12]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschrijving
[A13]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschrijving
[A28]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschrijving
[A14]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschrijving
[A29]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschrijving
[A18]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschrijving
[A19]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschrijving
[A10]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschrijving
[A11]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschrijving
[A32]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344429
- UMLS CUI [1,2]
- C0439673
- UMLS CUI [1,3]
- C0011900
Beschrijving
[A27]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042514
Beschrijving
[A30]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344431
Beschrijving
[A15]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschrijving
[A31]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
- UMLS CUI [2,1]
- C0344432
- UMLS CUI [2,2]
- C0750194
Beschrijving
[A16]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschrijving
[A99]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beschrijving
12 lead ECG, Abnormality, Electrocardiogram: Rhythm, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
- UMLS CUI [1,4]
- C0947611
Beschrijving
P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
Beschrijving
[B1]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beschrijving
[B2]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beschrijving
[B3]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0162770
Beschrijving
[B5]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346510
Beschrijving
[D14]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Beschrijving
[B99]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beschrijving
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Comment; 12 lead ECG, Abnormality, Electrocardiogram QRS complex, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2216025
- UMLS CUI [1,4]
- C0947611
- UMLS CUI [2,1]
- C0430456
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C0429098
- UMLS CUI [2,4]
- C0947611
Beschrijving
Conduction
Alias
- UMLS CUI-1
- C0264886
Beschrijving
[C1]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschrijving
[C2]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschrijving
[C3]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschrijving
[C16]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschrijving
[C4]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschrijving
[C5]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschrijving
[C6]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschrijving
[C7]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschrijving
[C13]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschrijving
[C8]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschrijving
[C14] synonymous to left anterior fascicular block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschrijving
[C15] synonymous to left posterior fascicular block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschrijving
[C9]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschrijving
[C17]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschrijving
[C10]
Datatype
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschrijving
[C11]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Beschrijving
[C12]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Beschrijving
[C18]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschrijving
[C99]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340494
Beschrijving
12 lead ECG, Abnormality, Cardiac Conduction, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [1,4]
- C0947611
Beschrijving
Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Beschrijving
[D1]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschrijving
[D2]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340293
Beschrijving
[D3]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340312
Beschrijving
[D4]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340319
Beschrijving
[D5]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340305
Beschrijving
[D6]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0746727
Beschrijving
[D20]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschrijving
[D98]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Beschrijving
12 lead ECG, Abnormality, Myocardial Infarction, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0027051
- UMLS CUI [1,4]
- C0947611
Beschrijving
Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
- UMLS CUI-2
- C1331539
Beschrijving
[D7]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschrijving
[D19]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschrijving
[D8]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschrijving
[D21]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348119
Beschrijving
[D9]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschrijving
[D10]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438169
Beschrijving
[D11]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschrijving
[D12]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschrijving
[D15]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschrijving
[D16]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschrijving
[D18]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschrijving
[D13]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschrijving
[D17]
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Beschrijving
[D99]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2746082
- UMLS CUI [2,1]
- C0948857
- UMLS CUI [2,2]
- C0205394
Beschrijving
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Comment; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1331539
- UMLS CUI [1,4]
- C0947611
- UMLS CUI [2,1]
- C0430456
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C0948857
- UMLS CUI [2,4]
- C0947611
Beschrijving
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Beschrijving
[E99]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Beschrijving
12 lead ECG, Abnormality, Other, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Similar models
12-Lead ECG Abnormalities
- StudyEvent: ODM
C0040223 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0750197 (UMLS CUI [1,2])
C0344432 (UMLS CUI [2,1])
C0750194 (UMLS CUI [2,2])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0232310 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,2])
C0149721 (UMLS CUI [1,3])
C0332437 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0429098 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
C0489625 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0027051 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C1331539 (UMLS CUI-2)
C0429059 (UMLS CUI [2])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0948857 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])