ID

40843

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 Concomitant Medications has to be filled in at the Screening Visit and throughout the study whenever a change in patient's medication is made.

Keywords

Versions (1)
  1. 5/24/20 5/24/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 24, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

English

Concomitant Medications

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Document Type
Description

Document Type

Data type

text

Alias
UMLS CUI [1]
C1547673
Concomintant Medications
Description

Concomintant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the study?
Description

If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
List of Concomintant Medications
Description

List of Concomintant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Description

Concomitant Agent Drug Name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Unit Dose
Description

Concomitant Agent Unit Dose

Data type

float

Alias
UMLS CUI [1]
C2826646
Units
Description

Concomitant Agent Unit

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Frequency
Description

Concomitant Agent Frequency

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

Concomitant Agent Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Reason for Medication
Description

Concomitant Agent Indication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Start Date
Description

Concomitant Agent Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Start Time
Description

Concomitant Agent Start Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Taken Prior to Study?
Description

Concomitant Agent Taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Stop Date
Description

Concomitant Agent Stop Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Stop Time
Description

Concomitant Agent Stop Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1522314
Ongoing Medication?
Description

Concomitant Agent Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Document Type
text
C1547673 (UMLS CUI [1])
Visit Type
Code List
Document Type
CL Item
Screening (Screening)
(Comment:en)
CL Item
Treatment Period (Treatment Period)
Item Group
Concomintant Medications
C2347852 (UMLS CUI-1)
Concomintant agents taken during the study
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
List of Concomintant Medications
C2347852 (UMLS CUI-1)
Concomitant Agent Drug Name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Agent Unit Dose
Item
Unit Dose
float
C2826646 (UMLS CUI [1])
Concomitant Agent Unit
Item
Units
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Concomitant Agent Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant Agent Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Agent Indication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Concomitant Agent Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Agent Start Time
Item
Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Concomitant Agent Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Agent Stop Date
Item
Stop Date
date
C2826744 (UMLS CUI [1])
Concomitant Agent Stop Time
Item
Stop Time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Concomitant Agent Ongoing
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
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