ID

32378

Description

This ODM file contains the form for documentation of any concomitant medication. To be assessed at screening and re-assessed at every visit. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. 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: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

Keywords

Versions (2)
  1. 10/28/18 10/28/18 -
  2. 10/28/18 10/28/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 28, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880

English

Concomitant Medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medication
Description

Concomitant Medication

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

MONITOR DATA VALIDATION CHECKS • Check that either ’Yes’ or ’No’ box at the top of the page has been completed. 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

text

Alias
UMLS CUI [1]
C2347852
List of Concomitant Medication
Description

List of Concomitant Medication

Alias
UMLS CUI-1
C2347852
Drug Name
Description

MONITOR DATA VALIDATION CHECKS Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred).

Data type

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Description

Unit Dose of Medication

Data type

float

Alias
UMLS CUI [1]
C2826646
Units
Description

INVESTIGATOR INSTRUCTIONS UNITS Abbreviation Label TAB = Tablet MCL = Microlitre ML = Millilitre L = Litre MCG = Microgram MG = Milligram G = Gram

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

INVESTIGATOR INSTRUCTIONS FREQUENCY Abbreviation Label OD/QD = 1 x Daily BID = 2 x Daily TID = 3 x Daily QID = 4 x Daily PRN = As required

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

INVESTIGATOR INSTRUCTIONS ROUTE Abbreviation Label IM = Intramuscular IH = Inhalation IV = Intravenous NS = Nasal TP = Topical PO = Oral VG = Vaginal

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Start Date
Description

INVESTIGATOR INSTRUCTIONS • Record unknown months as UNK. MONITOR DATA VALIDATION CHECKS • Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. • It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. • It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Data type

partialDate

Alias
UMLS CUI [1]
C2826734
Taken Prior to Study?
Description

Taken Prior to Study?

Data type

text

Alias
UMLS CUI [1]
C2826667
Stop Date
Description

MONITOR DATA VALIDATION CHECKS • Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. • It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Data type

partialDate

Alias
UMLS CUI [1]
C2826744
Ongoing Medication
Description

Ongoing Medication

Data type

text

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant Medication
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])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
text
C2347852 (UMLS CUI [1])
Concomitant medications
Code List
Were any concomitant medications taken by the subject prior to screening and/or during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
List of Concomitant Medication
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Unit Dose of Medication
Item
Unit Dose
float
C2826646 (UMLS CUI [1])
Unit of Dose of Medication
Item
Units
text
C1519795 (UMLS CUI [1])
Frequency of Medication
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route of Medication
Item
Route
text
C0013153 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Start Date of Medication
Item
Start Date
partialDate
C2826734 (UMLS CUI [1])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
Taken Prior to Study?
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Stop Date of Medication
Item
Stop Date
partialDate
C2826744 (UMLS CUI [1])
Item
Ongoing Medication
text
C2826666 (UMLS CUI [1])
Ongoing Medication
Code List
Ongoing Medication
CL Item
Yes (Y)
CL Item
No (N)
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