ID

41004

Beskrivning

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.

Nyckelord

Versioner (1)
  1. 2020-06-10 2020-06-10 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 juni 2020

DOI

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Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

Engelsk

Physical Examination

1 Formulär  
  1. StudyEvent: ODM
    1. Physical Examination
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Physical Examination
Beskrivning

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Beskrivning

Physical Examination Date

Datatyp

date

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

Physical examination Hair | Physical examination Skin

Datatyp

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:
Beskrivning

Physical examination Hair Description | Physical examination Skin Description

Datatyp

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
Beskrivning

Physical examination Lymph nodes

Datatyp

text

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

Physical examination Lymph nodes Description

Datatyp

text

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

Physical examination Eyes

Datatyp

text

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

Physical examination Eyes Description

Datatyp

text

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

Physical examination ENT

Datatyp

text

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

Physical examination ENT Description

Datatyp

text

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

Physical examination Breasts

Datatyp

text

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

Physical Examination Breasts Description

Datatyp

text

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

Physical examination Respiratory

Datatyp

text

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

Physical examination Respiratory Description

Datatyp

text

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

Physical examination Cardiovascular

Datatyp

text

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

Physical examination Cardiovascular Description

Datatyp

text

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

Physical examination Abdomen

Datatyp

text

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

Physical examination Abdomen Description

Datatyp

text

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

Physical examination Urogenital

Datatyp

text

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

Physical examination Urogenital Description

Datatyp

text

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

Physical examination Pelvis

Datatyp

text

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

Physical examination Pelvis Description

Datatyp

text

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

Physical examination Rectal

Datatyp

text

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

Physical examination Rectal Description

Datatyp

text

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

Physical examination Musculoskeletal

Datatyp

text

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

Physical examination Musculoskeletal Description

Datatyp

text

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

Physical examination Neurological

Datatyp

text

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

Physical Examination Neurological Description

Datatyp

text

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

Physical examination Mental status

Datatyp

text

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

Physical examination Mental status Description

Datatyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
UMLS CUI [1,3]
C0678257
Tillbaka till toppen

Similar models

Physical Examination

1 Formulär
  1. StudyEvent: ODM
    1. Physical Examination
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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