ID

29504

Beschrijving

Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Concomitant Medications

Trefwoorden

Versies (1)
  1. 04-04-18 04-04-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

4 april 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257

Engels

Concomitant Medications

1 Formulieren  
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Were any concomitant medications taken by the subject within 7 days prior to dosing and/or during the study?
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Drug Name
Beschrijving

Drug Name

Datatype

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Dose
Beschrijving

Dose

Datatype

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
Unit
Beschrijving

Unit

Datatype

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Route
Beschrijving

Route

Datatype

integer

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

Reason for Medication

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0392360
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
Start Time
Beschrijving

Start Time

Datatype

time

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

Taken Prior to Study?

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
Stop Date
Beschrijving

Stop Date

Datatype

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0806020
Stop time
Beschrijving

Stop time

Datatype

time

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

Ongoing Medication?

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Terug naar het begin van de pagina

Similar models

Concomitant Medications

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Concomitant medications
Item
Were any concomitant medications taken by the subject within 7 days prior to dosing and/or during the study?
boolean
C2347852 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Unit
Code List
Unit
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 [1,1])
C2347852 (UMLS CUI [1,2])
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
Route
integer
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Intramuscular (1)
(Comment:en)
CL Item
Inhalation (2)
(Comment:en)
CL Item
Intravenous (3)
(Comment:en)
CL Item
Nasal (4)
(Comment:en)
CL Item
Topical (5)
(Comment:en)
CL Item
Oral (6)
(Comment:en)
CL Item
Vaginal (7)
(Comment:en)
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop time
Item
Stop time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial