ID
32378
Beschreibung
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
Stichworte
Versionen (2)
- 28.10.18 28.10.18 -
- 28.10.18 28.10.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
28. Oktober 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880
Concomitant Medication
- StudyEvent: ODM
Beschreibung
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
List of Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
MONITOR DATA VALIDATION CHECKS Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred).
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
Beschreibung
Unit Dose of Medication
Datentyp
float
Alias
- UMLS CUI [1]
- C2826646
Beschreibung
INVESTIGATOR INSTRUCTIONS UNITS Abbreviation Label TAB = Tablet MCL = Microlitre ML = Millilitre L = Litre MCG = Microgram MG = Milligram G = Gram
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
INVESTIGATOR INSTRUCTIONS ROUTE Abbreviation Label IM = Intramuscular IH = Inhalation IV = Intravenous NS = Nasal TP = Topical PO = Oral VG = Vaginal
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
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.
Datentyp
partialDate
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Taken Prior to Study?
Datentyp
text
Alias
- UMLS CUI [1]
- C2826667
Beschreibung
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’.
Datentyp
partialDate
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Ongoing Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826666
Ähnliche Modelle
Concomitant Medication
- StudyEvent: ODM