ID

25739

Description

Adverse/ serious adverse event and study conclusion - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876 Study ID: 100789 Clinical Study ID: NKV100789 Study Title: A two-part, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of single intravenous doses of GW679769 when administered alone and in combination with intravenous or oral doses of dexamethasone in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 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

Keywords

Versions (1)
  1. 9/16/17 9/16/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 16, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Adverse/ serious adverse event and study conclusion - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

English

Adverse/ serious adverse event and study conclusion - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 forms  
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
This Subject has no Adverse Study Events
Description

Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Adverse event/Symptom
Description

Adverse event symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
Outcome
Description

If patient died -STOP , infonn GlaxoSmithKline invnediately and complete Serious AE form

Data type

text

Alias
UMLS CUI [1]
C1705586
Adverse Event Onset Date
Description

Adverse Event Onset Date

Data type

date

Alias
UMLS CUI [1]
C2985916
Adverse Event Onset Time
Description

Adverse Event Onset Time

Data type

time

Alias
UMLS CUI [1]
C2697889
Adverse Event End Date
Description

Adverse Event End Date

Data type

date

Alias
UMLS CUI [1]
C2697886
Adverse event end time
Description

Adverse event end time

Data type

time

Alias
UMLS CUI [1]
C2826658
Event Course
Description

adverse event course

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Number of episodes
Description

adverse event number of episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Description

Intensity of the adverse event

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Action Taken with Respect to lnvestigational Drug
Description

Action Taken in response to event

Data type

text

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C0877248
Relationship to Study Procedures
Description

Relationship to Study Procedures

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1510821
Check if Corrective Therapy given.
Description

if checked, record details in prior and concommitant medication forms and/or Resource utilization if appropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0087111
Checked if Patient Was Withdrawn Due to This Event.
Description

withdrawn due to event

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Serious adverse event
Description

Serious adverse event

Alias
UMLS CUI-1
C1519255
Verbatim SAE
Description

verbatim SAE

Data type

text

Alias
UMLS CUI [1]
C2699044
Outcome
Description

if patient died - STOP, inform GlaxoSmithKline immediately

Data type

text

Alias
UMLS CUI [1]
C1705586
Onset Date Serious adverse event
Description

Onset Date

Data type

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
Onset Time
Description

Onset time SAE

Data type

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1519255
End Date
Description

End Date SAE

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
End Time
Description

End Time SAE

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Event Course
Description

Event course SAE

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0750729
Number of episodes
Description

Number of episodes SAE

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Description

Intensity SAE

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
Action Taken with Respect to Investigational Drug
Description

Action Taken with Respect to Investigational Drug

Data type

text

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C1519255
Relationship to Study Procedures
Description

Relationship to Study Procedures SAE

Data type

text

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C1519255
Serious adverse event Code
Description

Serious adverse event Code

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
SAE association
Description

SAE association

Data type

text

Alias
UMLS CUI [1]
C1706737
Please specify SAE association
Description

SAE association

Data type

text

Alias
UMLS CUI [1,1]
C1706737
UMLS CUI [1,2]
C1521902
Did the SAE abate?
Description

SAE abate

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
Was Medication Re-Introduced?
Description

medication reintroduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0376495
Did SAE Recur?
Description

SAE recur

Data type

boolean

Alias
UMLS CUI [1]
C1546995
Check if Corrective Therapy given.
Description

if checked, record details in prior and concommitant medication forms and/or Resource utilization if appropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0087111
Checked if Patient Was Withdrawn Due to This Event.
Description

withdrawn due to event

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Random Code broken
Description

Random Code broken

Data type

boolean

Alias
UMLS CUI [1]
C0034656
Random number
Description

Random number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Remarks
Description

Remarks

Data type

text

Alias
UMLS CUI [1]
C0947611
Investigator signature
Description

Investigator signature

Alias
UMLS CUI-1
C2346576
As the Principal lnvestigator (Pl), I am signing this statement after site data management activities (data entry, review and correction) are complete and the eCRFs for this subject have been monitored by GSK representatives. Either I, as the Principal lmestigator, and/or my staff have the site data management actvities.
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator full name
Description

Investigator full name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator username
Description

Investigator username

Data type

text

Alias
UMLS CUI [1]
C2826689
Investigator Signature Date
Description

Investigator Signature Date

Data type

datetime

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Comment
Description

Comment

Alias
UMLS CUI-1
C0947611
Comment date
Description

Comment date

Data type

date

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0011008
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Comment category
Description

Comment category

Data type

text

Alias
UMLS CUI [1]
C1547758
Study phase
Description

Study phase

Data type

text

Alias
UMLS CUI [1]
C0920321
Session
Description

Session

Data type

text

Alias
UMLS CUI [1]
C1883017
Study conclusion
Description

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did subject complete study as planned?
Description

subject complete study as planned

Data type

boolean

Alias
UMLS CUI [1]
C2348577
If 'no' mark appropriate category.
Description

reason for study withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
Comments on reason for withdrawal
Description

Comments on reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0947611
Date of withdrawal
Description

Date of withdrawal

Data type

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
Time of withdrawal:
Description

Time of withdrawal

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2349954
Date of last dose
Description

Date of last dose

Data type

date

Alias
UMLS CUI [1]
C1762893
Time of last dose
Description

Time of last dose

Data type

time

Alias
UMLS CUI [1]
C0946444
As the Principal lnvestigator (Pl), I am signing this statement after site data management activities (data entry, review and correction) are complete and the eCRFs for this subject have been monitored by GSK representatives. Either I, as the Principal lmestigator, and/or my staff have the site data management actvities.
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator full name
Description

Investigator full name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator username
Description

Investigator username

Data type

text

Alias
UMLS CUI [1]
C2826689
Investigator Signature Date
Description

Investigator Signature Date

Data type

datetime

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Adverse/ serious adverse event and study conclusion - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Adverse event
Item
This Subject has no Adverse Study Events
boolean
C0877248 (UMLS CUI [1])
Adverse event symptom
Item
Adverse event/Symptom
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Adverse event outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Adverse Event Onset Date
Item
Adverse Event Onset Date
date
C2985916 (UMLS CUI [1])
Adverse Event Onset Time
Item
Adverse Event Onset Time
time
C2697889 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
Adverse event end time
Item
Adverse event end time
time
C2826658 (UMLS CUI [1])
adverse event course
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
adverse event number of episodes
Item
Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Intensity of the adverse event
Item
Intensity (maximum)
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Action Taken in response to event
Item
Action Taken with Respect to lnvestigational Drug
text
C1547656 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Relationship to Study Procedures
Item
Relationship to Study Procedures
text
C0877248 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
corrective therapy
Item
Check if Corrective Therapy given.
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
withdrawn due to event
Item
Checked if Patient Was Withdrawn Due to This Event.
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious adverse event
C1519255 (UMLS CUI-1)
verbatim SAE
Item
Verbatim SAE
text
C2699044 (UMLS CUI [1])
Outcome SAE
Item
Outcome
text
C1705586 (UMLS CUI [1])
Onset Date Serious adverse event
Item
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Onset time SAE
Item
Onset Time
time
C0449244 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Date SAE
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Time SAE
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Event course SAE
Item
Event Course
text
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Number of episodes SAE
Item
Number of episodes
integer
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Intensity SAE
Item
Intensity (maximum)
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Action Taken with Respect to Investigational Drug
Item
Action Taken with Respect to Investigational Drug
text
C2826626 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to Study Procedures SAE
Item
Relationship to Study Procedures
text
C1510821 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious adverse event Code
Item
Serious adverse event Code
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
SAE association
Item
SAE association
text
C1706737 (UMLS CUI [1])
SAE association
Item
Please specify SAE association
text
C1706737 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
SAE abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
medication reintroduced
Item
Was Medication Re-Introduced?
boolean
C0013227 (UMLS CUI [1,1])
C0376495 (UMLS CUI [1,2])
SAE recur
Item
Did SAE Recur?
boolean
C1546995 (UMLS CUI [1])
corrective therapy
Item
Check if Corrective Therapy given.
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
withdrawn due to event
Item
Checked if Patient Was Withdrawn Due to This Event.
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Random Code broken
Item
Random Code broken
boolean
C0034656 (UMLS CUI [1])
Random number
Item
Random number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator signature
Item
As the Principal lnvestigator (Pl), I am signing this statement after site data management activities (data entry, review and correction) are complete and the eCRFs for this subject have been monitored by GSK representatives. Either I, as the Principal lmestigator, and/or my staff have the site data management actvities.
text
C2346576 (UMLS CUI [1])
Investigator full name
Item
Investigator full name
text
C2826892 (UMLS CUI [1])
Investigator username
Item
Investigator username
text
C2826689 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
datetime
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Comment
C0947611 (UMLS CUI-1)
Comment date
Item
Comment date
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Comment category
Item
Comment category
text
C1547758 (UMLS CUI [1])
Study phase
Item
Study phase
text
C0920321 (UMLS CUI [1])
Session
Item
Session
text
C1883017 (UMLS CUI [1])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
subject complete study as planned
Item
Did subject complete study as planned?
boolean
C2348577 (UMLS CUI [1])
reason for study withdrawal
Item
If 'no' mark appropriate category.
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Comments on reason for withdrawal
Item
Comments on reason for withdrawal
text
C2348568 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Date of withdrawal
Item
Date of withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of withdrawal
Item
Time of withdrawal:
time
C0040223 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Date of last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Time of last dose
Item
Time of last dose
time
C0946444 (UMLS CUI [1])
Investigator signature
Item
As the Principal lnvestigator (Pl), I am signing this statement after site data management activities (data entry, review and correction) are complete and the eCRFs for this subject have been monitored by GSK representatives. Either I, as the Principal lmestigator, and/or my staff have the site data management actvities.
text
C2346576 (UMLS CUI [1])
Investigator full name
Item
Investigator full name
text
C2826892 (UMLS CUI [1])
Investigator username
Item
Investigator username
text
C2826689 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
datetime
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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