ID
32333
Description
This ODM file contains the form to document the physical examination, ecg, vital signs and medical history. To be assessed at screening. 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 (5)
- 10/19/18 10/19/18 -
- 10/26/18 10/26/18 -
- 10/26/18 10/26/18 -
- 10/26/18 10/26/18 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 26, 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
Medical History, Physical Examination, Vital Signs and ECG (Screening)
Description
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Description
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Data type
text
Alias
- UMLS CUI [1]
- C0011900
Description
CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0521116
Description
PAST MEDICAL CONDITIONS Conditions from which the subject has suffered in the past, but are no longer present. A past condition may have stopped as recently as the day prior to being assessed.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C1444637
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]
- C0031809
- UMLS CUI [2]
- C0558035
Description
Hair and Skin
Data type
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [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
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Blood pressure and heart rate are to be performed after the subject has been in a sitting position for at least 5 minutes followed by standing 1 minute later. Sitting
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure and heart rate are to be performed after the subject has been in a sitting position for at least 5 minutes followed by standing 1 minute later. 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
ECG
Alias
- UMLS CUI-1
- C1623258
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Medical History, Physical Examination, Vital Signs and ECG (Screening)
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C1444637 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
C0558035 (UMLS CUI [2])
C0031809 (UMLS CUI [1,2])
C0558035 (UMLS CUI [2])
C0024204 (UMLS CUI [1,2])
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