ID

41073

Beschreibung

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

Stichworte

Versionen (2)
  1. 19.06.20 19.06.20 -
  2. 19.06.20 19.06.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

19. Juni 2020

DOI

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Lizenz

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

Englisch

Concomitant Medication

1 Formulare  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject prior to dosing and/or during the study?
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Beschreibung

(Trade Name Preferred)

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Beschreibung

(eg.500mg)

Datentyp

float

Alias
UMLS CUI [1]
C0869039
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschreibung

(e.g.BID)

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Concomitant Medication Route
Beschreibung

Concomitant Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C2826730
Reason for Concomitant Medication
Beschreibung

Reason for Concomitant Medication

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Concomitant Medication Start Date
Beschreibung

Concomitant Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Concomitant Medication Start Time
Beschreibung

Concomitant Medication Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Concomitant medication taken prior to study?
Beschreibung

Concomitant medication taken prior to study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Concomitant Medication Stop Date
Beschreibung

Concomitant Medication Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Concomitant Medication Stop Time
Beschreibung

Concomitant Medication Stop Time

Datentyp

time

Alias
UMLS CUI [1]
C2826659
Ongoing medication?
Beschreibung

Ongoing medication?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
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Ähnliche Modelle

Concomitant Medication

1 Formulare
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Were any concomitant medications taken by the subject prior to dosing and/or during the study?
Item
Were any concomitant medications taken by the subject prior to dosing and/or during the study?
boolean
C2347852 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
float
C0869039 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
Tablet  (TAB)
CL Item
Microlitre  (MCL)
CL Item
Millilitre  (ML)
CL Item
Litre  (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Frequency
text
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
1 x Daily (OD/QD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
Item
Concomitant Medication Route
text
C2826730 (UMLS CUI [1])
Concomitant Medication Route
Code List
Concomitant Medication Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Reason for Concomitant Medication
Item
Reason for Concomitant Medication
text
C2826696 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Concomitant Medication Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medication Start Time
Item
Concomitant Medication Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Concomitant medication taken prior to study?
Item
Concomitant medication taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication Stop Date
Item
Concomitant Medication Stop Date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Stop Time
Item
Concomitant Medication Stop Time
time
C2826659 (UMLS CUI [1])
Ongoing medication?
Item
Ongoing medication?
boolean
C2826666 (UMLS CUI [1])
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