ID
32331
Beschrijving
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
Trefwoorden
Versies (5)
- 19-10-18 19-10-18 -
- 26-10-18 26-10-18 -
- 26-10-18 26-10-18 -
- 26-10-18 26-10-18 -
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 oktober 2018
DOI
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Licentie
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)
Beschrijving
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beschrijving
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0521116
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C1444637
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Hair and skin
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
Beschrijving
Hair and Skin
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [2]
- C0558035
Beschrijving
Lymph nodes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Beschrijving
Lymph nodes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Beschrijving
Eyes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Beschrijving
Eyes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Beschrijving
Ears, Nose and Throat
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Beschrijving
Ears, Nose and Throat
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Beschrijving
Breasts
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Beschrijving
Breasts
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Beschrijving
Respiratory
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0599324
Beschrijving
Respiratory
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0599324
Beschrijving
Cardiovascular
Datatype
integer
Alias
- UMLS CUI [1]
- C3854344
Beschrijving
Cardiovascular
Datatype
text
Alias
- UMLS CUI [1]
- C3854344
Beschrijving
Abdomen
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beschrijving
Abdomen
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beschrijving
Urogenital
Datatype
integer
Alias
- UMLS CUI [1]
- C1828035
Beschrijving
Urogenital
Datatype
text
Alias
- UMLS CUI [1]
- C1828035
Beschrijving
Pelvic
Datatype
integer
Alias
- UMLS CUI [1]
- C0200045
Beschrijving
Pelvic
Datatype
text
Alias
- UMLS CUI [1]
- C0200045
Beschrijving
Rectal
Datatype
integer
Alias
- UMLS CUI [1]
- C0199900
Beschrijving
Rectal
Datatype
text
Alias
- UMLS CUI [1]
- C0199900
Beschrijving
Musculoskeletal
Datatype
integer
Alias
- UMLS CUI [1]
- C0475091
Beschrijving
Musculoskeletal
Datatype
text
Alias
- UMLS CUI [1]
- C0475091
Beschrijving
Neurological
Datatype
integer
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
Neurological
Datatype
text
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
Mental status
Datatype
integer
Alias
- UMLS CUI [1]
- C3260990
Beschrijving
Mental Status
Datatype
text
Alias
- UMLS CUI [1]
- C3260990
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
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
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
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
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Sitting
Datatype
integer
Maateenheden
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
ECG
Alias
- UMLS CUI-1
- C1623258
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Medical History, Physical Examination, Vital Signs and ECG (Screening)
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C0024204 (UMLS CUI [1,2])
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