ID
40933
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 12-Lead ECG Abnormalities Form has to be filled in whenever an abnormal ECG curve is recorded durig the study.
Stichworte
Versionen (1)
- 07.06.20 07.06.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
7. Juni 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
12-Lead ECG Abnormalities
- StudyEvent: ODM
Beschreibung
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beschreibung
Rhythm
Alias
- UMLS CUI-1
- C0232187
Beschreibung
[A1]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
[A21]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
[A22]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
[A23]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
[A3]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschreibung
[A2]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Beschreibung
[A4]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschreibung
[A20]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschreibung
[A17]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschreibung
[A26]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C0018810
Beschreibung
[A6]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Beschreibung
[A7]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschreibung
[A8]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschreibung
[A5]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Beschreibung
[A25]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschreibung
[A24]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Beschreibung
[A9]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschreibung
[A12]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschreibung
[A13]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschreibung
[A28]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschreibung
[A14]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschreibung
[A29]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschreibung
[A18]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschreibung
[A19]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschreibung
[A10]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschreibung
[A11]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschreibung
[A32]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344429
- UMLS CUI [1,2]
- C0439673
- UMLS CUI [1,3]
- C0011900
Beschreibung
[A27]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042514
Beschreibung
[A30]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344431
Beschreibung
[A15]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschreibung
[A31]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
- UMLS CUI [2,1]
- C0344432
- UMLS CUI [2,2]
- C0750194
Beschreibung
[A16]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschreibung
[A99]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beschreibung
12 lead ECG, Abnormality, Electrocardiogram: Rhythm, Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
- UMLS CUI [1,4]
- C0947611
Beschreibung
P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
Beschreibung
[B1]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beschreibung
[B2]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beschreibung
[B3]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0162770
Beschreibung
[B5]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346510
Beschreibung
[D14]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Beschreibung
[B99]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beschreibung
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Comment; 12 lead ECG, Abnormality, Electrocardiogram QRS complex, Comment
Datentyp
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
Beschreibung
Conduction
Alias
- UMLS CUI-1
- C0264886
Beschreibung
[C1]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschreibung
[C2]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschreibung
[C3]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschreibung
[C16]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschreibung
[C4]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschreibung
[C5]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschreibung
[C6]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschreibung
[C7]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschreibung
[C13]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschreibung
[C8]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschreibung
[C14] synonymous to left anterior fascicular block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschreibung
[C15] synonymous to left posterior fascicular block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschreibung
[C9]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschreibung
[C17]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschreibung
[C10]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschreibung
[C11]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Beschreibung
[C12]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Beschreibung
[C18]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschreibung
[C99]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340494
Beschreibung
12 lead ECG, Abnormality, Cardiac Conduction, Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [1,4]
- C0947611
Beschreibung
Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Beschreibung
[D1]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschreibung
[D2]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340293
Beschreibung
[D3]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340312
Beschreibung
[D4]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340319
Beschreibung
[D5]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340305
Beschreibung
[D6]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0746727
Beschreibung
[D20]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschreibung
[D98]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Beschreibung
12 lead ECG, Abnormality, Myocardial Infarction, Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0027051
- UMLS CUI [1,4]
- C0947611
Beschreibung
Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
- UMLS CUI-2
- C1331539
Beschreibung
[D7]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschreibung
[D19]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschreibung
[D8]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschreibung
[D21]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348119
Beschreibung
[D9]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschreibung
[D10]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0438169
Beschreibung
[D11]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschreibung
[D12]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschreibung
[D15]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschreibung
[D16]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschreibung
[D18]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschreibung
[D13]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschreibung
[D17]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Beschreibung
[D99]
Datentyp
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
Beschreibung
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Comment; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Comment
Datentyp
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
Beschreibung
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Beschreibung
[E99]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Beschreibung
12 lead ECG, Abnormality, Other, Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Ähnliche Modelle
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])