ID

40796

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 Form has to be filled in at following visits: Screening, Treatment Period 1 Predose, Treatment Period 1 Prior to Discharge, Treatment Period 2 Predose, Treatment Period 2 Prior to Discharge, and whenever extra measurements are done during the study (Unscheduled).

Stichworte

Versionen (1)
  1. 15.05.20 15.05.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15. Mai 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

Englisch

12-Lead ECG

1 Formulare  
  1. StudyEvent: ODM
    1. 12-Lead ECG
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beschreibung

Visit Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG number
Beschreibung

To be filled in only at pre-dose visits. ECG measurement should be done three times at pre-dose visits.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beschreibung

12 lead ECG; Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Beschreibung

12 lead ECG; Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Beschreibung

12 lead ECG; Ventricular Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
bpm
PR Interval
Beschreibung

12 lead ECG; PR Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beschreibung

12 lead ECG; QRS complex Duration

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beschreibung

12 lead ECG; QT interval finding

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beschreibung

12 lead ECG; QTc Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Beschreibung

Option 4 can be selected only at pre-dose visits. At pre-dose and unscheduled visits: Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. At all visits: Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C1274040
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Ähnliche Modelle

12-Lead ECG

1 Formulare
  1. StudyEvent: ODM
    1. 12-Lead ECG
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Screening (Screening)
(Comment:en)
CL Item
Treatment Period 1 Predose (Treatment Period 1 Predose)
(Comment:en)
CL Item
Treatment Period 1 Prior to Discharge (Treatment Period 1 Prior to Discharge)
(Comment:en)
CL Item
Treatment Period 2 Predose (Treatment Period 2 Predose)
(Comment:en)
CL Item
Treatment Period 2 Prior to Discharge (Treatment Period 2 Prior to Discharge)
(Comment:en)
CL Item
Unscheduled (Unscheduled)
(Comment:en)
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
12 lead ECG; ECG Number
Code List
ECG number
CL Item
ECG1 (1)
(Comment:en)
CL Item
ECG2 (2)
(Comment:en)
CL Item
ECG3 (3)
(Comment:en)
12 lead ECG; Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
12 lead ECG; Start Time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
12 lead ECG; Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
12 lead ECG; PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG; QRS complex Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG; QT interval finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG; QTc Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
12 lead ECG; result
Code List
Result of the ECG
CL Item
Normal (1)
(Comment:en)
CL Item
Abnormal - Not clinically significant  (2)
(Comment:en)
CL Item
Abnormal - Clinically significant (3)
(Comment:en)
CL Item
No result (not available) (4)
(Comment:en)
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