ID

41004

Beschreibung

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects 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: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Physical Examination Form is used to record the physical examination at screening visit.

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  1. 10.06.20 10.06.20 -
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GlaxoSmithKline

Hochgeladen am

10. Juni 2020

DOI

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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

Englisch

Physical Examination

1 Formulare  
  1. StudyEvent: ODM
    1. Physical Examination
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
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Beschreibung

Physical Examination Date

Datentyp

date

Alias
UMLS CUI [1]
C2826643
1. Hair and skin
Beschreibung

Physical examination Hair | Physical examination Skin

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018494
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C1123023
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Hair Description | Physical examination Skin Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018494
UMLS CUI [1,3]
C0678257
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C1123023
UMLS CUI [2,3]
C0678257
2. Lymph nodes
Beschreibung

Physical examination Lymph nodes

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Lymph nodes Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
UMLS CUI [1,3]
C0678257
3. Eyes
Beschreibung

Physical examination Eyes

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015392
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Eyes Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015392
UMLS CUI [1,3]
C0678257
4. Ears, Nose and Throat
Beschreibung

Physical examination ENT

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
If ABNORMAL, describe concisely:
Beschreibung

Physical examination ENT Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
UMLS CUI [1,3]
C0678257
5. Breasts
Beschreibung

Physical examination Breasts

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
If ABNORMAL, describe concisely:
Beschreibung

Physical Examination Breasts Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
UMLS CUI [1,3]
C0678257
6. Respiratiory
Beschreibung

Physical examination Respiratory

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0035237
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Respiratory Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0035237
UMLS CUI [1,3]
C0678257
7. Cardiovascular
Beschreibung

Physical examination Cardiovascular

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0007226
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Cardiovascular Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0007226
UMLS CUI [1,3]
C0678257
8. Abdomen
Beschreibung

Physical examination Abdomen

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Abdomen Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C0678257
9. Urogenital
Beschreibung

Physical examination Urogenital

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1828035
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Urogenital Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1828035
UMLS CUI [1,3]
C0678257
10. Pelvic
Beschreibung

Physical examination Pelvis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Pelvis Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C0678257
11. Rectal
Beschreibung

Physical examination Rectal

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199900
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Rectal Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199900
UMLS CUI [1,3]
C0678257
12. Musculoskeletal
Beschreibung

Physical examination Musculoskeletal

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0026860
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Musculoskeletal Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0026860
UMLS CUI [1,3]
C0678257
13. Neurological
Beschreibung

Physical examination Neurological

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
If ABNORMAL, describe concisely:
Beschreibung

Physical Examination Neurological Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
UMLS CUI [1,3]
C0678257
14. Mental Status
Beschreibung

Physical examination Mental status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
If ABNORMAL, describe concisely:
Beschreibung

Physical examination Mental status Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
UMLS CUI [1,3]
C0678257
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Ähnliche Modelle

Physical Examination

1 Formulare
  1. StudyEvent: ODM
    1. Physical Examination
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
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination Date
Item
Date of Assessment
date
C2826643 (UMLS CUI [1])
Item
1. Hair and skin
text
C0031809 (UMLS CUI [1,1])
C0018494 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
Physical examination Hair | Physical examination Skin
Code List
1. Hair and skin
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Physical examination Hair Description | Physical examination Skin Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0018494 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0678257 (UMLS CUI [2,3])
Item
2. Lymph nodes
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Physical examination Hair | Physical examination Skin
Code List
2. Lymph nodes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Physical examination Lymph nodes Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
3. Eyes
text
C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
Physical examination Hair | Physical examination Skin
Code List
3. Eyes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Physical examination Eyes Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
4. Ears, Nose and Throat
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
Physical examination Hair | Physical examination Skin
Code List
4. Ears, Nose and Throat
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Physical examination ENT Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
5. Breasts
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
Physical examination Breasts
Code List
5. Breasts
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Physical Examination Breasts Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
6. Respiratiory
text
C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
Physical examination Hair | Physical examination Skin
Code List
6. Respiratiory
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Physical examination Respiratory Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
7. Cardiovascular
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
Physical examination Hair | Physical examination Skin
Code List
7. Cardiovascular
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Physical examination Cardiovascular Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
8. Abdomen
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Physical examination Hair | Physical examination Skin
Code List
8. Abdomen
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Physical examination Abdomen Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
9. Urogenital
text
C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])
Physical examination Breasts
Code List
9. Urogenital
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Physical examination Urogenital Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
10. Pelvic
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Physical examination Breasts
Code List
10. Pelvic
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Physical examination Pelvis Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
11. Rectal
text
C0031809 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
Physical examination Breasts
Code List
11. Rectal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Physical examination Rectal Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
12. Musculoskeletal
text
C0031809 (UMLS CUI [1,1])
C0026860 (UMLS CUI [1,2])
Physical examination Hair | Physical examination Skin
Code List
12. Musculoskeletal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Physical examination Musculoskeletal Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0026860 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
13. Neurological
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
Physical examination Hair | Physical examination Skin
Code List
13. Neurological
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Physical Examination Neurological Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
14. Mental Status
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Physical examination Hair | Physical examination Skin
Code List
14. Mental Status
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Physical examination Mental status Description
Item
If ABNORMAL, describe concisely:
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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