ID

25693

Descrição

Medical and Medication History, Concomitant Meds - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876 Study ID: 100789 Clinical Study ID: NKV100789 Study Title: A two-part, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of single intravenous doses of GW679769 when administered alone and in combination with intravenous or oral doses of dexamethasone in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 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

Palavras-chave

Versões (1)
  1. 10/09/2017 10/09/2017 -
Titular dos direitos

glaxoSmithKline

Transferido a

10 de setembro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Medical and Medication History, Concomitant Meds - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

Inglês

Medical and Medication History, Concomitant Meds - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 Formulários  
Medical history
Descrição

Medical history

Alias
UMLS CUI-1
C0262926
Date of medical history
Descrição

Medical history date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011008
Time of medical history
Descrição

Medical history time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0040223
Is the subject or has the subject suffered from any significant medical or surgical condition?
Descrição

lf "Yes", list one diagnosis per line below. Only in the absence of a diagnosis, record the signs and symptoms on separate lines.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012634
Disease
Descrição

Disease

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0012634
Diagnosis
Descrição

Diagnosis

Tipo de dados

text

Alias
UMLS CUI [1]
C0011900
Year of first diagnosis
Descrição

Year of first diagnosis

Tipo de dados

partialDate

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Diagnosis in the past
Descrição

Past disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444637
Diagnosis ongoing
Descrição

Ongoing disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0012634
Medication history
Descrição

Medication history

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0013227
Date of medication history
Descrição

Date of medication history

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0013227
Time of medication history
Descrição

Medication history time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0013227
Has the subject taken any medication during the time period specific in the protocol prior to first dose of the investigational product?
Descrição

If "Yes", please record al medications used below. Medical indications recorded here must conelate with either diagnoses (or symptoms) listed in the medical/surgical history or physical exam forms.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0013227
Medication history
Descrição

Medication history

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0013227
Drug name (trade name preferred)
Descrição

Trade name

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C059250
Dose
Descrição

Drug Dose

Tipo de dados

float

Alias
UMLS CUI [1]
C0678766
Frequency
Descrição

Frequency of pharmaceutical preparation

Tipo de dados

text

Alias
UMLS CUI [1]
C3476109
Route
Descrição

Route

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
Mark if continue during study
Descrição

Pharmaceutical preparation continuous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Medical illness or diagnosis
Descrição

Diagnosis

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0013227
Start date
Descrição

pharmaceutical preparation start date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Descrição

pharmaceutical preparation end date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Concomitant Medication
Descrição

Concomitant Medication

Alias
UMLS CUI-1
C2347852
History Date
Descrição

Concomitant medication Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0011008
History Time
Descrição

Concomitant Medication Time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0040223
Has the subject taken any medication during the study?
Descrição

If "Yes", please record all medications used below. Where appropriate medical conditions should be recorded on the Adverse Event Form utilizing the same terminology for the medical illness/diagnosis. If a Continuing Medication Dosage has changed or the medication was stopped, record the change below if not already recorded as a Prior Medication.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant medication
Descrição

Concomitant medication

Alias
UMLS CUI-1
C2347852
Drug name (trade name preferred)
Descrição

Trade name

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C059250
Dose
Descrição

Drug dose

Tipo de dados

float

Alias
UMLS CUI [1]
C0678766
Frequency
Descrição

Frequency of medication

Tipo de dados

text

Alias
UMLS CUI [1]
C3476109
Medical illness or diagnosis
Descrição

Diagnosis concomitant medication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C2347852
Start date
Descrição

Start date concomitant medication

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
Start time
Descrição

Start time concomitant medication

Tipo de dados

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2347852
End date
Descrição

End date concomitant medication

Tipo de dados

date

Alias
UMLS CUI [1]
C2826744
End time
Descrição

End time concomitant medication

Tipo de dados

time

Alias
UMLS CUI [1]
C2826659
Mark if continue during study
Descrição

Pharmaceutical preparation continuous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
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Similar models

Medical and Medication History, Concomitant Meds - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Medical history
C0262926 (UMLS CUI-1)
Medical history date
Item
Date of medical history
date
C0262926 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Medical history time
Item
Time of medical history
time
C0262926 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
medical condition
Item
Is the subject or has the subject suffered from any significant medical or surgical condition?
boolean
C0262926 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item Group
Disease
C0262926 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Past disease
Item
Diagnosis in the past
boolean
C0012634 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Ongoing disease
Item
Diagnosis ongoing
boolean
C0549178 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item Group
Medication history
C0262926 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Date of medication history
Item
Date of medication history
date
C0011008 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Medication history time
Item
Time of medication history
time
C0040223 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
medication history
Item
Has the subject taken any medication during the time period specific in the protocol prior to first dose of the investigational product?
boolean
C0262926 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Medication history
C0262926 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Trade name
Item
Drug name (trade name preferred)
text
C0013227 (UMLS CUI [1,1])
C059250 (UMLS CUI [1,2])
Drug Dose
Item
Dose
float
C0678766 (UMLS CUI [1])
Frequency of pharmaceutical preparation
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Pharmaceutical preparation continuous
Item
Mark if continue during study
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Diagnosis
Item
Medical illness or diagnosis
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
pharmaceutical preparation start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
pharmaceutical preparation end date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant medication Date
Item
History Date
date
C2347852 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Concomitant Medication Time
Item
History Time
time
C2347852 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Concomitant medication
Item
Has the subject taken any medication during the study?
boolean
C2347852 (UMLS CUI [1])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Trade name
Item
Drug name (trade name preferred)
text
C0013227 (UMLS CUI [1,1])
C059250 (UMLS CUI [1,2])
Drug dose
Item
Dose
float
C0678766 (UMLS CUI [1])
Frequency of medication
Item
Frequency
text
C3476109 (UMLS CUI [1])
Diagnosis concomitant medication
Item
Medical illness or diagnosis
text
C0011900 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Start date concomitant medication
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Start time concomitant medication
Item
Start time
time
C1301880 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
End date concomitant medication
Item
End date
date
C2826744 (UMLS CUI [1])
End time concomitant medication
Item
End time
time
C2826659 (UMLS CUI [1])
Pharmaceutical preparation continuous
Item
Mark if continue during study
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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