ID

32003

Beschreibung

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Stichworte

  1. 11.10.18 11.10.18 -
  2. 25.02.19 25.02.19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

11. Oktober 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0

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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Physical Examination Form

Medical Conditions
Beschreibung

Medical Conditions

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Diagnosis
Beschreibung

Only in the absence of a diagnosis, record the signs and symptoms on separate lines Diagnosis 1 Diagnosis 2 Diagnosis 3 Diagnosis 4 Diagnosis 5 Diagnosis 6 Diagnosis 7

Datentyp

text

Current Diagnosis
Beschreibung

Diagnosis 1 Diagnosis 2 Diagnosis 3 Diagnosis 4 Diagnosis 5 Diagnosis 6 Diagnosis 7

Datentyp

boolean

Past Diagnosis
Beschreibung

Diagnosis 1 Diagnosis 2 Diagnosis 3 Diagnosis 4 Diagnosis 5 Diagnosis 6 Diagnosis 7

Datentyp

boolean

Physical Examination
Beschreibung

Physical Examination

Date of Assesment
Beschreibung

Date of Assesment

Datentyp

date

Indicate current physical findings by marking the appropriate box(es) below and if ABNORMAL, describe concisely:
Beschreibung

[different findings should be separated by either a (:) or a (/)]

Datentyp

text

1.Hair and skin
Beschreibung

1.Hair and skin

Datentyp

text

2.Lymph nodes
Beschreibung

2.Lymph nodes

Datentyp

text

3.Eyes
Beschreibung

3.Eyes

Datentyp

text

4.Ears, Nose and Throat
Beschreibung

4.Ears, Nose and Throat

Datentyp

text

5.Breasts
Beschreibung

5.Breasts

Datentyp

text

6.Respiratory
Beschreibung

6.Respiratory

Datentyp

text

7.Cardiovascular
Beschreibung

7.Cardiovascular

Datentyp

text

8.Abdomen
Beschreibung

8.Abdomen

Datentyp

text

9.Urogenital
Beschreibung

9.Urogenital

Datentyp

text

10.Pelvic
Beschreibung

10.Pelvic

Datentyp

text

11.Rectal
Beschreibung

11.Rectal

Datentyp

text

12.Musculoskeletal
Beschreibung

12.Musculoskeletal

Datentyp

text

13.Neurological
Beschreibung

13.Neurological

Datentyp

text

14.Mental Status
Beschreibung

14.Mental Status

Datentyp

text

Concise Description
Beschreibung

1 Hair and Skin 2 Lymph Nodes 3 Eyes 4 Ears, Nose and Throat 5 Breasts 6 Respiratory 7 Cardiovascular 8 Abdomen 9 Urogenital 10 Pelvic 11 Rectal 12 Musculoskeletal 13 Neurological 14 Mental Status

Datentyp

text

Urine Drug, Alcohol and Cotinine Screen
Beschreibung

Urine Drug, Alcohol and Cotinine Screen

Date of sample taken
Beschreibung

Date of sample taken

Datentyp

date

Time of sample taken
Beschreibung

Time of sample taken

Datentyp

time

Mark appropriate box(es):
Beschreibung

Mark appropriate box(es):

Datentyp

text

Cocaine
Beschreibung

Cocaine

Datentyp

integer

Amphetamines
Beschreibung

Amphetamines

Datentyp

integer

Benzodiazepines
Beschreibung

Benzodiazepines

Datentyp

integer

Cannabinoids
Beschreibung

Cannabinoids

Datentyp

integer

Opiates
Beschreibung

Opiates

Datentyp

text

Barbiturates
Beschreibung

Barbiturates

Datentyp

integer

Alcohol
Beschreibung

Alcohol

Datentyp

integer

Cotinine
Beschreibung

Cotinine

Datentyp

integer

If any of the above are positive, exclude subject from the study.
Beschreibung

If any of the above are positive, exclude subject from the study.

Datentyp

text

Serology
Beschreibung

Serology

Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Mark appropriate boxes:
Beschreibung

Mark appropriate boxes:

Datentyp

text

HIV antibody
Beschreibung

HIV antibody

Datentyp

integer

Hepatitis B surface antigen
Beschreibung

Hepatitis B surface antigen

Datentyp

integer

Hepatitis C antibody
Beschreibung

Hepatitis C antibody

Datentyp

integer

If any of the above are positive, exclude subject from the study.
Beschreibung

If any of the above are positive, exclude subject from the study.

Datentyp

text

Vital Signs
Beschreibung

Vital Signs

Date
Beschreibung

Date

Datentyp

date

Time
Beschreibung

Time

Datentyp

time

Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
kg
Body mass index
Beschreibung

Body mass index

Datentyp

float

Maßeinheiten
  • kg / m2
kg / m2
Blood pressure Systolic
Beschreibung

Semi-supine

Datentyp

integer

Maßeinheiten
  • mmHg
mmHg
Blood pressure Diastolic
Beschreibung

Semi-supine

Datentyp

integer

Maßeinheiten
  • mmHg
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
°C
Respiration rate
Beschreibung

Respiration rate

Datentyp

integer

Maßeinheiten
  • breaths/min
breaths/min
12-lead ECG (Semi-Supine)
Beschreibung

12-lead ECG (Semi-Supine)

Start Date of ECG
Beschreibung

Start Date of ECG

Datentyp

date

Start Time of ECG
Beschreibung

Start Time of ECG

Datentyp

time

Ventricular Rate
Beschreibung

Ventricular Rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • msec
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • msec
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

text

Maßeinheiten
  • msec
msec
QTc Interval
Beschreibung

QTc Interval

Datentyp

integer

Maßeinheiten
  • msec
msec
Result of the ECG
Beschreibung

mark one:

Datentyp

text

Ähnliche Modelle

Physical Examination Form

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Medical Conditions
Subject Identifier
Item
Subject Identifier
integer
Item
Diagnosis
text
Code List
Diagnosis
CL Item
Diagnosis 1 (Diagnosis 1)
CL Item
Diagnosis 2 (Diagnosis 2)
CL Item
Diagnosis 3 (Diagnosis 3)
CL Item
Diagnosis 4 (Diagnosis 4)
CL Item
Diagnosis 5 (Diagnosis 5)
CL Item
Diagnosis 6 (Diagnosis 6)
CL Item
Diagnosis 7 (Diagnosis 7)
Current Diagnosis
Item
Current Diagnosis
boolean
Past Diagnosis
Item
Past Diagnosis
boolean
Item Group
Physical Examination
Date of Assesment
Item
Date of Assesment
date
Indicate current physical findings by marking the appropriate box(es) below and if ABNORMAL, describe concisely:
Item
Indicate current physical findings by marking the appropriate box(es) below and if ABNORMAL, describe concisely:
text
Item
1.Hair and skin
text
Code List
1.Hair and skin
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
2.Lymph nodes
text
Code List
2.Lymph nodes
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
3.Eyes
text
Code List
3.Eyes
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
4.Ears, Nose and Throat
text
Code List
4.Ears, Nose and Throat
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
5.Breasts
text
Code List
5.Breasts
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Item
6.Respiratory
text
Code List
6.Respiratory
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
7.Cardiovascular
text
Code List
7.Cardiovascular
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
8.Abdomen
text
Code List
8.Abdomen
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
9.Urogenital
text
Code List
9.Urogenital
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Item
10.Pelvic
text
Code List
10.Pelvic
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Item
11.Rectal
text
Code List
11.Rectal
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Item
12.Musculoskeletal
text
Code List
12.Musculoskeletal
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
13.Neurological
text
Code List
13.Neurological
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
14.Mental Status
text
Code List
14.Mental Status
CL Item
Normal (1)
CL Item
Abnormal (2)
Concise Description
Item
Concise Description
text
Item Group
Urine Drug, Alcohol and Cotinine Screen
Date of sample taken
Item
Date of sample taken
date
Time of sample taken
Item
Time of sample taken
time
Mark appropriate box(es):
Item
Mark appropriate box(es):
text
Item
Cocaine
integer
Code List
Cocaine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
integer
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
integer
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
integer
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
text
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
integer
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Alcohol
integer
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cotinine
integer
Code List
Cotinine
CL Item
Positive (1)
CL Item
Negative (2)
If any of the above are positive, exclude subject from the study.
Item
If any of the above are positive, exclude subject from the study.
text
Item Group
Serology
Date sample taken
Item
Date sample taken
date
Mark appropriate boxes:
Item
Mark appropriate boxes:
text
Item
HIV antibody
integer
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis B surface antigen
integer
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
integer
Code List
Hepatitis C antibody
CL Item
Positive (1)
CL Item
Negative (2)
If any of the above are positive, exclude subject from the study.
Item
If any of the above are positive, exclude subject from the study.
text
Item Group
Vital Signs
Date
Item
Date
date
Time
Item
Time
time
Height
Item
Height
integer
Weight
Item
Weight
float
Body mass index
Item
Body mass index
float
Blood pressure Systolic
Item
Blood pressure Systolic
integer
Blood pressure Diastolic
Item
Blood pressure Diastolic
integer
Heart rate
Item
Heart rate
integer
Temperature
Item
Temperature
float
Respiration rate
Item
Respiration rate
integer
Item Group
12-lead ECG (Semi-Supine)
Start Date of ECG
Item
Start Date of ECG
date
Start Time of ECG
Item
Start Time of ECG
time
Ventricular Rate
Item
Ventricular Rate
integer
PR Interval
Item
PR Interval
integer
QRS Duration
Item
QRS Duration
integer
Uncorrected QT Interval
Item
Uncorrected QT Interval
text
QTc Interval
Item
QTc Interval
integer
Item
Result of the ECG
text
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinocally significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)

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