ID

32333

Beschreibung

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

Stichworte

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Rechteinhaber

GlaxoSmithKline

Hochgeladen am

26. Oktober 2018

DOI

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

Englisch

Medical History, Physical Examination, Vital Signs and ECG (Screening)

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Medical Conditions
Beschreibung

Medical Conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0009488
Diagnosis
Beschreibung

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Is the diagnosis current?
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0521116
Is the diagnosis past?
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1444637
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Hair and skin
Beschreibung

Hair and skin

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0031809
UMLS CUI [2]
C0558035
Hair and Skin: If Abnormal, please specify
Beschreibung

Hair and Skin

Datentyp

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0031809
UMLS CUI [2]
C0558035
Lymph nodes
Beschreibung

Lymph nodes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
Lymph nodes: If Abnormal, please specify
Beschreibung

Lymph nodes

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
Eyes
Beschreibung

Eyes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0200149
Eyes: If Abnormal, please specify
Beschreibung

Eyes

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0200149
Ears, Nose and Throat
Beschreibung

Ears, Nose and Throat

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
Ears, Nose and Throat: If Abnormal, please specify
Beschreibung

Ears, Nose and Throat

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
Breasts
Beschreibung

Breasts

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
Breasts: If Abnormal or not done, please specify
Beschreibung

Breasts

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
Respiratory
Beschreibung

Respiratory

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0599324
Respiratory: If Abnormal, please specify
Beschreibung

Respiratory

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0599324
Cardiovascular
Beschreibung

Cardiovascular

Datentyp

integer

Alias
UMLS CUI [1]
C3854344
Cardiovascular: If Abnormal, please specify
Beschreibung

Cardiovascular

Datentyp

text

Alias
UMLS CUI [1]
C3854344
Abdomen
Beschreibung

Abdomen

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Abdomen: If Abnormal, please specify
Beschreibung

Abdomen

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Urogenital
Beschreibung

Urogenital

Datentyp

integer

Alias
UMLS CUI [1]
C1828035
Urogenital: If abnormal or not done, please specify
Beschreibung

Urogenital

Datentyp

text

Alias
UMLS CUI [1]
C1828035
Pelvic
Beschreibung

Pelvic

Datentyp

integer

Alias
UMLS CUI [1]
C0200045
Pelvic: If Abnormal or not done, please specify
Beschreibung

Pelvic

Datentyp

text

Alias
UMLS CUI [1]
C0200045
Rectal
Beschreibung

Rectal

Datentyp

integer

Alias
UMLS CUI [1]
C0199900
Rectal: If abnormal or not done, please specify
Beschreibung

Rectal

Datentyp

text

Alias
UMLS CUI [1]
C0199900
Musculoskeletal
Beschreibung

Musculoskeletal

Datentyp

integer

Alias
UMLS CUI [1]
C0475091
Musculoskeletal: If Abnormal, please specify
Beschreibung

Musculoskeletal

Datentyp

text

Alias
UMLS CUI [1]
C0475091
Neurological
Beschreibung

Neurological

Datentyp

integer

Alias
UMLS CUI [1]
C0027853
Neurological: If Abnormal, please specify
Beschreibung

Neurological

Datentyp

text

Alias
UMLS CUI [1]
C0027853
Mental status
Beschreibung

Mental status

Datentyp

integer

Alias
UMLS CUI [1]
C3260990
Mental Status: If Abnormal, please specify
Beschreibung

Mental Status

Datentyp

text

Alias
UMLS CUI [1]
C3260990
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic blood pressure
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Sitting

Datentyp

integer

Maßeinheiten
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
ECG
Beschreibung

ECG

Alias
UMLS CUI-1
C1623258
Result of the ECG ✔ one:
Beschreibung

In case of clinically significant abnormality: Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.

Datentyp

text

Alias
UMLS CUI [1]
C0438154
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Ähnliche Modelle

Medical History, Physical Examination, Vital Signs and ECG (Screening)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Medical Conditions
C0262926 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Is the diagnosis current?
Item
Is the diagnosis current?
boolean
C0011900 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Is the diagnosis past?
Item
Is the diagnosis past?
boolean
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Hair and skin
integer
C0018494 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0558035 (UMLS CUI [2])
Hair and skin
Code List
Hair and skin
CL Item
Normal (1)
CL Item
Abnormal (2)
Hair and Skin
Item
Hair and Skin: If Abnormal, please specify
text
C0018494 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0558035 (UMLS CUI [2])
Item
Lymph nodes
integer
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Lymph nodes
Code List
Lymph nodes
CL Item
Normal (1)
CL Item
Abnormal (2)
Lymph nodes
Item
Lymph nodes: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Item
Eyes
integer
C0031809 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
Eyes
Code List
Eyes
CL Item
Normal (1)
CL Item
Abnormal (2)
Eyes
Item
Eyes: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
Item
Ears, Nose and Throat
integer
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
Ears, Nose and Throat
Code List
Ears, Nose and Throat
CL Item
Normal (1)
CL Item
Abnormal (2)
Ears, Nose and Throat
Item
Ears, Nose and Throat: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
Item
Breasts
integer
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
Breasts
Code List
Breasts
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Breasts
Item
Breasts: If Abnormal or not done, please specify
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
Item
Respiratory
integer
C0031809 (UMLS CUI [1,1])
C0599324 (UMLS CUI [1,2])
Respiratory
Code List
Respiratory
CL Item
Normal (1)
CL Item
Abnormal (2)
Respiratory
Item
Respiratory: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0599324 (UMLS CUI [1,2])
Item
Cardiovascular
integer
C3854344 (UMLS CUI [1])
Cardiovascular
Code List
Cardiovascular
CL Item
Normal (1)
CL Item
Abnormal (2)
Cardiovascular
Item
Cardiovascular: If Abnormal, please specify
text
C3854344 (UMLS CUI [1])
Item
Abdomen
integer
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Abdomen
Code List
Abdomen
CL Item
normal (1)
CL Item
abnormal (2)
Abdomen
Item
Abdomen: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Item
Urogenital
integer
C1828035 (UMLS CUI [1])
Urogenital
Code List
Urogenital
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Urogenital
Item
Urogenital: If abnormal or not done, please specify
text
C1828035 (UMLS CUI [1])
Item
Pelvic
integer
C0200045 (UMLS CUI [1])
Pelvic
Code List
Pelvic
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Pelvic
Item
Pelvic: If Abnormal or not done, please specify
text
C0200045 (UMLS CUI [1])
Item
Rectal
integer
C0199900 (UMLS CUI [1])
Rectal
Code List
Rectal
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Rectal
Item
Rectal: If abnormal or not done, please specify
text
C0199900 (UMLS CUI [1])
Item
Musculoskeletal
integer
C0475091 (UMLS CUI [1])
Musculoskeletal
Code List
Musculoskeletal
CL Item
Normal (1)
CL Item
Abnormal (2)
Musculoskeletal
Item
Musculoskeletal: If Abnormal, please specify
text
C0475091 (UMLS CUI [1])
Item
Neurological
integer
C0027853 (UMLS CUI [1])
Neurological
Code List
Neurological
CL Item
Normal (1)
CL Item
Abnormal (2)
Neurological
Item
Neurological: If Abnormal, please specify
text
C0027853 (UMLS CUI [1])
Item
Mental status
integer
C3260990 (UMLS CUI [1])
Mental status
Code List
Mental status
CL Item
Normal (1)
CL Item
Abnormal (2)
Mental Status
Item
Mental Status: If Abnormal, please specify
text
C3260990 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Result of the ECG ✔ one:
text
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG ✔ one:
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
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