ID

41067

Beschrijving

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

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Versies (1)
  1. 18-06-20 18-06-20 -
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GlaxoSmithKline

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18 juni 2020

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Creative Commons BY-NC 4.0
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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447

Engels

Pharmacokinetics - Blood

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Pharmacokinetics - Blood (Session 1)
Beschrijving

Pharmacokinetics - Blood (Session 1)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beschrijving

Sample Number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 1)
Beschrijving

Pharmacokinetics - Blood (Session 1)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beschrijving

Sample Number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 2)
Beschrijving

Pharmacokinetics - Blood (Session 2)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beschrijving

Sample Number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 2)
Beschrijving

Pharmacokinetics - Blood (Session 2)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beschrijving

Sample Number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 3)
Beschrijving

Pharmacokinetics - Blood (Session 3)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beschrijving

Sample Number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 3)
Beschrijving

Pharmacokinetics - Blood (Session 3)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beschrijving

Sample Number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 4)
Beschrijving

Pharmacokinetics - Blood (Session 4)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beschrijving

Sample Number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 4)
Beschrijving

Pharmacokinetics - Blood (Session 4)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beschrijving

Sample Number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
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Pharmacokinetics - Blood

1 Formulieren
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C1320722 (UMLS CUI-1)
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104 (4)
CL Item
105 (5)
CL Item
106 (6)
CL Item
107 (7)
CL Item
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CL Item
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CL Item
115 (4)
CL Item
116 (5)
CL Item
117 (6)
CL Item
118 (7)
CL Item
119 (8)
CL Item
120 (9)
CL Item
121 (10)
CL Item
122 (11)
CL Item
123 (12)
CL Item
124 (13)
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CL Item
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CL Item
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204 (4)
CL Item
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CL Item
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CL Item
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209 (9)
CL Item
210 (10)
CL Item
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C0005767 (UMLS CUI-2)
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CL Item
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CL Item
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CL Item
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CL Item
213 (2)
CL Item
214 (3)
CL Item
215 (4)
CL Item
216 (5)
CL Item
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CL Item
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CL Item
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C0005767 (UMLS CUI-2)
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CL Item
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CL Item
0.5 hr  (2)
CL Item
1 hr  (3)
CL Item
1.5 hr  (4)
CL Item
2 hr  (5)
CL Item
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CL Item
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CL Item
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CL Item
304 (4)
CL Item
305 (5)
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306 (6)
CL Item
307 (7)
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CL Item
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CL Item
1 hr  (3)
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CL Item
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CL Item
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CL Item
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date
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time
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Sample Number
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Sample Number
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CL Item
313 (2)
CL Item
314 (3)
CL Item
315 (4)
CL Item
316 (5)
CL Item
317 (6)
CL Item
318 (7)
CL Item
319 (8)
CL Item
320 (9)
CL Item
321 (10)
CL Item
322 (11)
CL Item
323 (12)
CL Item
324 (13)
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C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose  (1)
CL Item
0.5 hr  (2)
CL Item
1 hr  (3)
CL Item
1.5 hr  (4)
CL Item
2 hr  (5)
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CL Item
6 hr  (8)
CL Item
8 hr  (9)
CL Item
12 hr (10)
CL Item
24 hr (11)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
401 (1)
CL Item
402 (2)
CL Item
403 (3)
CL Item
404 (4)
CL Item
405 (5)
CL Item
406 (6)
CL Item
407 (7)
CL Item
408 (8)
CL Item
409 (9)
CL Item
410 (10)
CL Item
411 (11)
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C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose  (1)
CL Item
0.5 hr  (2)
CL Item
1 hr  (3)
CL Item
1.5 hr  (4)
CL Item
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CL Item
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CL Item
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CL Item
36 hr (12)
CL Item
48 hr (13)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
412 (1)
CL Item
413 (2)
CL Item
414 (3)
CL Item
415 (4)
CL Item
416 (5)
CL Item
417 (6)
CL Item
418 (7)
CL Item
419 (8)
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420 (9)
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421 (10)
CL Item
422 (11)
CL Item
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424 (13)
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