ID
32151
Description
This ODM file contains a form for the documention required at the follow-up and unscheduled visits. 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)
- 10/21/18 10/21/18 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 21, 2018
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880
Follow-Up Visit und Unscheduled Visit Form
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Sitting
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Sitting
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Sitting
Data type
integer
Measurement units
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Hair and skin
Data type
integer
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
Description
Hair and Skin
Data type
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
Description
Lymph nodes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Description
Lymph nodes
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Description
Eyes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Description
Eyes
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Description
Ears, Nose and Throat
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Description
Ears, Nose and Throat
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Description
Breasts
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Description
Breasts
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Description
Respiratory
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0599324
Description
Respiratory
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0599324
Description
Cardiovascular
Data type
integer
Alias
- UMLS CUI [1]
- C3854344
Description
Cardiovascular
Data type
text
Alias
- UMLS CUI [1]
- C3854344
Description
Abdomen
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Description
Abdomen
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Description
Urogenital
Data type
integer
Alias
- UMLS CUI [1]
- C1828035
Description
Urogenital
Data type
text
Alias
- UMLS CUI [1]
- C1828035
Description
Pelvic
Data type
integer
Alias
- UMLS CUI [1]
- C0200045
Description
Pelvic
Data type
text
Alias
- UMLS CUI [1]
- C0200045
Description
Rectal
Data type
integer
Alias
- UMLS CUI [1]
- C0199900
Description
Rectal
Data type
text
Alias
- UMLS CUI [1]
- C0199900
Description
Musculoskeletal
Data type
integer
Alias
- UMLS CUI [1]
- C0475091
Description
Musculoskeletal
Data type
text
Alias
- UMLS CUI [1]
- C0475091
Description
Neurological
Data type
integer
Alias
- UMLS CUI [1]
- C0027853
Description
Neurological
Data type
text
Alias
- UMLS CUI [1]
- C0027853
Description
Mental status
Data type
integer
Alias
- UMLS CUI [1]
- C3260990
Description
Mental Status
Data type
text
Alias
- UMLS CUI [1]
- C3260990
Similar models
Follow-Up Visit und Unscheduled Visit Form
- StudyEvent: ODM
C0558035 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,2])
C0200149 (UMLS CUI [1,2])
C0278350 (UMLS CUI [1,2])
C0278350 (UMLS CUI [1,2])
C0199850 (UMLS CUI [1,2])
C0599324 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])