Informações:
Falhas:
ID
44403
Descrição
https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr Study ID : 102886/003 Clinical Study ID : 102886/003 Study Title :Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. Clinicaltrials.gov Identifier : Sponsor : GlaxoSmithKline Collaborators :N/A Phase :N/A Study Recruitment Status :Completed Generic Name :halofantrine Trade Name :Halfan Study Indication Malaria
Link
https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr
Palavras-chave
Versões (2)
- 05/06/2018 05/06/2018 - Halim Ugurlu
- 20/09/2021 20/09/2021 -
Titular dos direitos
GlaxoSmithKline (GSK)
Transferido a
20 de setembro de 2021
DOI
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Licença
Creative Commons BY-NC 3.0
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Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers.
Glucose assay, plasma drug assay, volunteer completion/withdrawal, investigator's statement, concominant medication, missing data form
Similar models
Glucose assay, plasma drug assay, volunteer completion/withdrawal, investigator's statement, concominant medication, missing data form
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Vol. No.
Item
Vol. No.
text
C2348585 (UMLS CUI [1])
Panel ID.
Item
Panel ID.
text
C3846158 (UMLS CUI [1])
Study Period
Item
Study Period
text
C2347804 (UMLS CUI [1])
start time infusion
Item
Actual time of start of infusion
datetime
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Time Relative to start of infusion
integer
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
CL Item
-5 mins (1)
CL Item
+15 mins (2)
CL Item
+30 mins (3)
CL Item
+50 mins (4)
CL Item
+75 mins (5)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C0200345 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
start of infusion
Item
Actual time of start of infusion
datetime
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Item
Time relative to start of infusion
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
CL Item
-0.5 hours (1)
CL Item
+0.25 hours (2)
CL Item
+0.5 hours (3)
CL Item
+0.83 hours (4)
CL Item
+2 hours (5)
CL Item
+3 hours (6)
CL Item
+5 hours (7)
CL Item
+7 hours (8)
CL Item
+10 hours (9)
CL Item
+12 hours (10)
CL Item
+24 hours (11)
CL Item
+48 hours (12)
CL Item
+72 hours (13)
CL Item
+144 hours (14)
CL Item
+216 hours (15)
CL Item
+336 hours (16)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C0200345 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Item Group
Volunteer Completion/Withdrawal
C0805732 (UMLS CUI-1)
C2349954 (UMLS CUI-2)
C2349954 (UMLS CUI-2)
Date/time
Item
Date/time
datetime
C1264639 (UMLS CUI [1])
Did the volunteer complete the study?
Item
Did the volunteer complete the study?
boolean
C2348577 (UMLS CUI [1])
Item
If no, please complete the following
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Significant adverse events (adverse events form must be completed) (3)
CL Item
Lack of subject compliance (4)
CL Item
Subject lost to follow-up (5)
CL Item
Protocol violation (specify below) (6)
CL Item
Concurrent disease (specify below) (7)
CL Item
Other reason (specify below) (8)
Reason for withdrawal
Item
Reason for withdrawal-Details
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
When did the volunteer last take any study medication
Item
When did the volunteer last take any study medication?
datetime
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,2])
Item Group
Investigator's checklist
C1707357 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
C0008961 (UMLS CUI-2)
all Adverse Event forms are up to date and complete
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Concominant Medication form is up to date
Item
Check that the Concominant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
all pages are signed (thus indicating completion) and dated
Item
Check that all pages are signed (thus indicating completion) and dated
boolean
C1283174 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
laboratory results are included
Item
Check that laboratory results are included
boolean
C1254595 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,2])
Recorder's initials
Item
Recorder's initials
text
C2986440 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
Study director
Item
Study director
text
C0025081 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
Item Group
Investigator's Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
C1710187 (UMLS CUI-2)
Investigator-take full responsibility
Item
I.........(the investigator) take full responsibility for the pages completed in this book.
text
C0678341 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
C2826892 (UMLS CUI [1,2])
Study Director
Item
Study Director
text
C0025081 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Freq/day
Item
Freq/day
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Start Date and Time
Item
Start Date and Time
datetime
C0808070 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
End Date and Time
Item
End Date and Time
datetime
C0806020 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Continuing at the end of the study
Item
Continuing at the end of the study
boolean
C1553904 (UMLS CUI [1])
undefined item
Item
If no concominant medication is taken during the study, please select
boolean
C2347852 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,2])
Study Day
Item
Study Day
date
C2826182 (UMLS CUI [1])
Missing Data Point
Item
Missing Data Point
text
C0814891 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Initials
Item
Initials
text
C3166278 (UMLS CUI [1])
Study Day
Item
Study Day
date
C2826182 (UMLS CUI [1])
Missing Data Point
Item
Missing Data Point
text
C0814891 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Initials
Item
Initials
text
C3166278 (UMLS CUI [1])
Study Day
Item
Study Day
date
C2826182 (UMLS CUI [1])
Missing Data Point
Item
Missing Data Point
text
C0814891 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Initials
Item
Initials
text
C3166278 (UMLS CUI [1])
Study Day
Item
Study Day
date
C2826182 (UMLS CUI [1])
Missing Data Point
Item
Missing Data Point
text
C0814891 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Initials
Item
Initials
text
C3166278 (UMLS CUI [1])