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