Age
Item
Is the volunteer aged between 21 and 39 years?
boolean
C0001779 (UMLS CUI [1])
compherensive pre-study medical examination
Item
Has the volunteer passed a compherensive pre-study medical examination during the week prior to the start of each study section, including: -medical history -clinical examination -electrocardiography (12 leads) -blood pressure -weight and height determination -pulmonary function test -haematological, clinical chemistry examinations, urinalysis and drug screening?
boolean
C0262926 (UMLS CUI [1,1])
C0031809 (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])
pathological findings
Item
Does the volunteer have pathological findings in any of the investigations stated in the Inclusion Criteria?
boolean
C0205469 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
receiving medicine
Item
Is the volunteer currently receiving, or taken within the previous 7 days prior to dosing, any other medicine (prescribed or over-the-counter drugs) ?
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
received a research drug
Item
Has the volunteer received a research drug within the last 8 weeks (i.e, a compound which has not been granted a product licence) ?
boolean
C0013230 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
alcohol abuse and/or have taken drugs of abuse
Item
Is the volunteer known to practice alcohol abuse and/or have taken drugs of abuse (e.g. as shown by a positive finding in the drug screen) ?
boolean
C0085762 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
weight/height ratio deviations
Item
Has the volunteer weight/height ratio deviations of more than 25% from the average (the average may be calculated by expressing the height above 100 m as a figure expressed in kg (Broca Formula) )
boolean
C0005890 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
allergic status
Item
Does the volunteer have a known or suspected allergic status?
boolean
C0018759 (UMLS CUI [1,1])
C0155877 (UMLS CUI [1,2])
C1527304 (UMLS CUI [1,3])
history of psychiatric disorders, epilepsy or seizures
Item
Does the volunteer have a history of psychiatric disorders, epilepsy or seizures?
boolean
C0262926 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0036572 (UMLS CUI [1,3])
C0014544 (UMLS CUI [1,4])
anti-malarial frugs within the last 12 months
Item
Has the volunteer taken anti-malarial frugs within the last 12 months?
boolean
C0003374 (UMLS CUI [1])
Date of infusion
Item
Date of infusion
date
C0574032 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time commenced
Item
Time commenced
time
C0011008 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
Time completed
Item
Time completed
time
C0574032 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Duration of infusion
Item
Duration of infusion
integer
C0444917 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Volunteer weight on Day-1
Item
Volunteer weight on Day-1
float
C0005910 (UMLS CUI [1])
Volume of infusion
Item
Volume of infusion
integer
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Dose checked and administred by
Item
Dose checked and administred by
text
C0178602 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Item
Time Relative to start of infusion
integer
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Code List
Time Relative to start of infusion
CL Item
-0.5 to 0 hours (1)
CL Item
0 to +0.5 hours (2)
CL Item
+0.5 to +1.5 hours (3)
CL Item
+1.5 to 2.5 hours (4)
CL Item
+2.5 to +3.5 hours (5)
CL Item
+3.5 to +4.5 hours (6)
CL Item
+4.5 to +5.5 hours (7)
CL Item
+5.5 to +6.5 hours (8)
CL Item
+6.5 to +7.5 hours (9)
CL Item
+7.5 to +8.5 hours (10)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Couplets (per time inverval)
Item
Couplets (per time inverval)
text
C0429001 (UMLS CUI [1])
Bigeminus
Item
Bigeminus (per time interval)
text
C0262662 (UMLS CUI [1])
EVPB (per time interval)
Item
EVPB (per time interval)
text
C0151636 (UMLS CUI [1])
VPB
Item
VPB (per time interval)
text
C0865677 (UMLS CUI [1])
initials
Item
initials
text
C2986440 (UMLS CUI [1])
ECG recordings carried out
Item
Were there any ECG recordings carried out?
boolean
C1623258 (UMLS CUI [1])
Item
Time relative to start of infusion
integer
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Code List
Time relative to start of infusion
CL Item
+0.5 to +1.5 hours (3)
CL Item
+49.25 hours (10)
Date and time taken
Item
Date and time taken
datetime
C0011008 (UMLS CUI [1])
ECG normal
Item
Is the ECG normal
boolean
C0522054 (UMLS CUI [1])
Any changes
Item
Any changes
boolean
C0855329 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
Item
Study time relevant to dose
integer
C0439564 (UMLS CUI [1])
Code List
Study time relevant to dose
Date and time sample taken
Item
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
any alcohol detected
Item
Was there any alcohol detected?
boolean
C0202306 (UMLS CUI [1])
initials
Item
initials
text
C2986440 (UMLS CUI [1])
Item
Day/hr relative to dose
integer
C0439564 (UMLS CUI [1])
Code List
Day/hr relative to dose
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Drugs detected
Item
Were there any Drugs detected?
boolean
C1511790 (UMLS CUI [1,1])
C1254351 (UMLS CUI [1,2])
Type of drug/compound found
Item
Type of drug/compound found
text
C0457591 (UMLS CUI [1])
Contra indicated?
Item
Contra indicated?
boolean
C1301624 (UMLS CUI [1])
Initials Lab
Item
Initials Lab
text
C0022877 (UMLS CUI [1])
Initials Physician
Item
Initials Physician
text
C2986440 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Felt different in any way over tha last few days
Item
Have you felt different in any way over the last few days?
boolean
C0559546 (UMLS CUI [1])
ADECS Code
Item
ADECS Code
text
C0805701 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Event Observed (describe)
Item
Event Observed (describe)
text
C0877248 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Onset date and time
Item
Onset date and time
datetime
C2826806 (UMLS CUI [1])
End date and time
Item
End date and time
datetime
C2826793 (UMLS CUI [1])
Event duration
Item
Event duration
text
C0449238 (UMLS CUI [1])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item
Outcome of Event
integer
C1705586 (UMLS CUI [1])
Code List
Outcome of Event
CL Item
Event continuing (1)
CL Item
Event resolved (2)
Recorder's signature
Item
Recorder's signature
text
C1519316 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Study Director's Signature
Item
Study Director's Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
adverse event observed or elicited
Item
Do you feel different in any way since starting the new treatment or since the last visit?
boolean
C0559546 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
ADECS Code
Item
ADECS Code
text
C0805701 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Event observed (describe)
Item
Event observed (describe)
text
C0877248 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Onset date and time
Item
Onset date and time
datetime
C2985916 (UMLS CUI [1])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Event continuing (1)
CL Item
event resolved (2)
Item
Event course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
End date and time
Item
End date and time
datetime
C2826793 (UMLS CUI [1])
Event (or severity) duration
Item
Event (or severity) duration
text
C0877248 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
Relation to investigational drug
integer
C0877248 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relation to investigational drug
CL Item
Possibly related (2)
Item
Present before or at baseline assessment?
integer
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Code List
Present before or at baseline assessment?
Item
Action taken (on study drug dosage)
integer
C2826626 (UMLS CUI [1])
Code List
Action taken (on study drug dosage)
CL Item
Dose interrupted (2)
CL Item
Drug withdrawn* (4)
Item
Outcome of event (select more than one if necessary)
integer
C1705586 (UMLS CUI [1])
Code List
Outcome of event (select more than one if necessary)
CL Item
Corrective therapy given** (1)
CL Item
Life threatening* (2)
CL Item
Significantly disabling* (3)
CL Item
Pat. hosp./Hosp. prolonged* (4)
CL Item
Patient died* (5)
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])