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.
Keywords
Versions (1)
- 6/7/20 6/7/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 7, 2020
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
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]
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
[A21]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
[A22]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
[A23]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
[A3]
Data type
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
[A2]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Description
[A4]
Data type
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
[A20]
Data type
boolean
Alias
- UMLS CUI [1]
- C2348376
Description
[A17]
Data type
boolean
Alias
- UMLS CUI [1]
- C1321523
Description
[A26]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C0018810
Description
[A6]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Description
[A7]
Data type
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
[A8]
Data type
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
[A5]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Description
[A25]
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
[A24]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Description
[A9]
Data type
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
[A12]
Data type
boolean
Alias
- UMLS CUI [1]
- C0429001
Description
[A13]
Data type
boolean
Alias
- UMLS CUI [1]
- C0262662
Description
[A28]
Data type
boolean
Alias
- UMLS CUI [1]
- C0428999
Description
[A14]
Data type
boolean
Alias
- UMLS CUI [1]
- C1142551
Description
[A29]
Data type
boolean
Alias
- UMLS CUI [1]
- C0877658
Description
[A18]
Data type
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
[A19]
Data type
boolean
Alias
- UMLS CUI [1]
- C0700363
Description
[A10]
Data type
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
[A11]
Data type
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
[A32]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344429
- UMLS CUI [1,2]
- C0439673
- UMLS CUI [1,3]
- C0011900
Description
[A27]
Data type
boolean
Alias
- UMLS CUI [1]
- C0042514
Description
[A30]
Data type
boolean
Alias
- UMLS CUI [1]
- C0344431
Description
[A15]
Data type
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
[A31]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
- UMLS CUI [2,1]
- C0344432
- UMLS CUI [2,2]
- C0750194
Description
[A16]
Data type
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
[A99]
Data type
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
Data type
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]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Description
[B2]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Description
[B3]
Data type
boolean
Alias
- UMLS CUI [1]
- C0162770
Description
[B5]
Data type
boolean
Alias
- UMLS CUI [1]
- C2346510
Description
[D14]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Description
[B99]
Data type
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
Data type
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]
Data type
boolean
Alias
- UMLS CUI [1]
- C0085614
Description
[C2]
Data type
boolean
Alias
- UMLS CUI [1]
- C0264907
Description
[C3]
Data type
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
[C16]
Data type
boolean
Alias
- UMLS CUI [1]
- C2346542
Description
[C4]
Data type
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
[C5]
Data type
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
[C6]
Data type
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
[C7]
Data type
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
[C13]
Data type
boolean
Alias
- UMLS CUI [1]
- C0281878
Description
[C8]
Data type
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
[C14] synonymous to left anterior fascicular block
Data type
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
[C15] synonymous to left posterior fascicular block
Data type
boolean
Alias
- UMLS CUI [1]
- C0264913
Description
[C9]
Data type
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
[C17]
Data type
boolean
Alias
- UMLS CUI [1]
- C0264914
Description
[C10]
Data type
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
[C11]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Description
[C12]
Data type
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Description
[C18]
Data type
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
[C99]
Data type
boolean
Alias
- UMLS CUI [1]
- C0340494
Description
12 lead ECG, Abnormality, Cardiac Conduction, Comment
Data type
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]
Data type
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
[D2]
Data type
boolean
Alias
- UMLS CUI [1]
- C0340293
Description
[D3]
Data type
boolean
Alias
- UMLS CUI [1]
- C0340312
Description
[D4]
Data type
boolean
Alias
- UMLS CUI [1]
- C0340319
Description
[D5]
Data type
boolean
Alias
- UMLS CUI [1]
- C0340305
Description
[D6]
Data type
boolean
Alias
- UMLS CUI [1]
- C0746727
Description
[D20]
Data type
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
[D98]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Description
12 lead ECG, Abnormality, Myocardial Infarction, Comment
Data type
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]
Data type
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
[D19]
Data type
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
[D8]
Data type
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
[D21]
Data type
boolean
Alias
- UMLS CUI [1]
- C2348119
Description
[D9]
Data type
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
[D10]
Data type
boolean
Alias
- UMLS CUI [1]
- C0438169
Description
[D11]
Data type
boolean
Alias
- UMLS CUI [1]
- C0520888
Description
[D12]
Data type
boolean
Alias
- UMLS CUI [1]
- C0239242
Description
[D15]
Data type
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
[D16]
Data type
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
[D18]
Data type
boolean
Alias
- UMLS CUI [1]
- C2347367
Description
[D13]
Data type
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
[D17]
Data type
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Description
[D99]
Data type
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
Data type
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]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Description
12 lead ECG, Abnormality, Other, Comment
Data type
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])