ID
40933
Description
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.
Mots-clés
Versions (1)
- 07/06/2020 07/06/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
7 juin 2020
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 4.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
12-Lead ECG Abnormalities
- StudyEvent: ODM
Description
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Description
Rhythm
Alias
- UMLS CUI-1
- C0232187
Description
[A1]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
[A21]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
[A22]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
[A23]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
[A3]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
[A2]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Description
[A4]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
[A20]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348376
Description
[A17]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1321523
Description
[A26]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C0018810
Description
[A6]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Description
[A7]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
[A8]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
[A5]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Description
[A25]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
[A24]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Description
[A9]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
[A12]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0429001
Description
[A13]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0262662
Description
[A28]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0428999
Description
[A14]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1142551
Description
[A29]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0877658
Description
[A18]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
[A19]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0700363
Description
[A10]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
[A11]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
[A32]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344429
- UMLS CUI [1,2]
- C0439673
- UMLS CUI [1,3]
- C0011900
Description
[A27]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042514
Description
[A30]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0344431
Description
[A15]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
[A31]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
- UMLS CUI [2,1]
- C0344432
- UMLS CUI [2,2]
- C0750194
Description
[A16]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
[A99]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Description
12 lead ECG, Abnormality, Electrocardiogram: Rhythm, Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
- UMLS CUI [1,4]
- C0947611
Description
P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
Description
[B1]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Description
[B2]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Description
[B3]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0162770
Description
[B5]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2346510
Description
[D14]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Description
[B99]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Description
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Comment; 12 lead ECG, Abnormality, Electrocardiogram QRS complex, Comment
Type de données
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
Description
Conduction
Alias
- UMLS CUI-1
- C0264886
Description
[C1]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085614
Description
[C2]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264907
Description
[C3]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
[C16]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2346542
Description
[C4]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
[C5]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
[C6]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
[C7]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
[C13]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0281878
Description
[C8]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
[C14] synonymous to left anterior fascicular block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
[C15] synonymous to left posterior fascicular block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264913
Description
[C9]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
[C17]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264914
Description
[C10]
Type de données
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
[C11]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Description
[C12]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Description
[C18]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
[C99]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340494
Description
12 lead ECG, Abnormality, Cardiac Conduction, Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [1,4]
- C0947611
Description
Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Description
[D1]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
[D2]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340293
Description
[D3]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340312
Description
[D4]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340319
Description
[D5]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340305
Description
[D6]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0746727
Description
[D20]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
[D98]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Description
12 lead ECG, Abnormality, Myocardial Infarction, Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0027051
- UMLS CUI [1,4]
- C0947611
Description
Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
- UMLS CUI-2
- C1331539
Description
[D7]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
[D19]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
[D8]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
[D21]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348119
Description
[D9]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
[D10]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0438169
Description
[D11]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520888
Description
[D12]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0239242
Description
[D15]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
[D16]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
[D18]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347367
Description
[D13]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
[D17]
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Description
[D99]
Type de données
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
Description
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Comment; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Comment
Type de données
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
Description
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Description
[E99]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Description
12 lead ECG, Abnormality, Other, Comment
Type de données
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])