Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Information
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
Malaria Signs and Symptoms
C0037088 (UMLS CUI-1)
C0024530 (UMLS CUI-2)
Item
Chills and rigors
text
C0036973 (UMLS CUI [1])
Code List
Chills and rigors
Item
Headache
text
C0018681 (UMLS CUI [1])
Item
Dizziness
text
C0012833 (UMLS CUI [1])
Item
Abdominal Pain
text
C0000737 (UMLS CUI [1])
Item
Anorexia
text
C0003123 (UMLS CUI [1])
Item
Nausea
text
C0027497 (UMLS CUI [1])
Item
Vomiting
text
C0042963 (UMLS CUI [1])
Item
Diarrhoea
text
C0011991 (UMLS CUI [1])
Item
Pruritis/itching
text
C0033774 (UMLS CUI [1])
Code List
Pruritis/itching
Item
Coughing
text
C0010200 (UMLS CUI [1])
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Vital Signs-24 Hours Post First Dose (Pre-dose)
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item
Location of Temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Code List
Location of Temperature
Item Group
Vital Signs-32 Hours Post First Dose
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item
Location of Temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Code List
Location of Temperature
Item Group
Vital Signs-40 Hours Post First Dose
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item
Location of Temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Code List
Location of Temperature
Item Group
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 24 Hours Post First Dose
C3661511 (UMLS CUI-1)
C0024530 (UMLS CUI-2)
C0086960 (UMLS CUI-3)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
P. falciparum Results
Item
P. falciparum Results
text
C0032150 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
P. vivax Results
Item
P. vivax Results
text
C0032154 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
P. ovale Results
Item
P. ovale Results
text
C0320744 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
P. malariae Results
Item
P. malariae Results
text
C0032153 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Unknown Results
Item
Unknown Results
text
C0439673 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Item Group
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 32 Hours Post First Dose
C3661511 (UMLS CUI-1)
C0024530 (UMLS CUI-2)
C0086960 (UMLS CUI-3)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
P. falciparum Results
Item
P. falciparum Results
text
C0032150 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
P. vivax Results
Item
P. vivax Results
text
C0032154 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
P. ovale Results
Item
P. ovale Results
text
C0320744 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
P. malariae Results
Item
P. malariae Results
text
C0032153 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Unknown Results
Item
Unknown Results
text
C0439673 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Item Group
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 40 Hours Post First Dose
C3661511 (UMLS CUI-1)
C0024530 (UMLS CUI-2)
C0086960 (UMLS CUI-3)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
P. falciparum Results
Item
P. falciparum Results
text
C0032150 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
P. vivax Results
Item
P. vivax Results
text
C0032154 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
P. ovale Results
Item
P. ovale Results
text
C0320744 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
P. malariae Results
Item
P. malariae Results
text
C0032153 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Unknown Results
Item
Unknown Results
text
C0439673 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Item Group
GAMETOCYTE - SINGLE ASSESSMENT (24 HOURS POST FIRST DOSE)
C0686869 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Item
Species
integer
C1705920 (UMLS CUI [1])
CL Item
P. falciparum (1)
CL Item
P. m a l a r i a e (4)
Item
Result
text
C1274040 (UMLS CUI [1])
Count /UL
Item
Count /UL
text
C0750480 (UMLS CUI [1])
Item Group
LABORATORY RESULT DATA (HAEMATOLOGY)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Address
Item
Address
text
C3262820 (UMLS CUI [1])
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])
WBC Result
Item
WBC Result
text
C0023508 (UMLS CUI [1])
RBC Result
Item
RBC Result
text
C1287262 (UMLS CUI [1])
Haemoglobin Result
Item
Haemoglobin Result
text
C0518015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Haematocrit Result
Item
Haematocrit Result
text
C0018935 (UMLS CUI [1])
Absolute Reticulocytes
Item
Absolute Reticulocytes
text
C0206161 (UMLS CUI [1])
Reticulocytes (Percentage)
Item
Reticulocytes (Percentage)
text
C1167975 (UMLS CUI [1])
Platelets
Item
Platelets
text
C0005821 (UMLS CUI [1])
Methaemoglobin Result
Item
Methaemoglobin Result
text
C1274040 (UMLS CUI [1,1])
C0025635 (UMLS CUI [1,2])
Item Group
CONFIRMATION OF LABORATORY RESULTS
C1254595 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
haemoglobin values
Item
Has there been a drop of >=40% of baseline haemoglobin and/or blood transfusions, and/or haemoglobin values of <5g/dL?
boolean
C0518015 (UMLS CUI [1])
Item
Is methaemoglobin >=20% or >= 10% but <20% with associated clinical symptoms of methaemoglobinaemia?
integer
C0025637 (UMLS CUI [1])
Code List
Is methaemoglobin >=20% or >= 10% but <20% with associated clinical symptoms of methaemoglobinaemia?
CL Item
Not applicable (3)
Item Group
PHARMACOKINETICS - PLASMA
C0031328 (UMLS CUI-1)
C0032105 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Code List
Planned Relative Time
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Attach Sample Identifier Label Here
Item
Attach Sample Identifier Label Here
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT: CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO
C0304229 (UMLS CUI-1)
C0055470 (UMLS CUI-2)
C0010980 (UMLS CUI-3)
C0052432 (UMLS CUI-4)
C0032042 (UMLS CUI-6)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Dose (tab)
Item
Dose (tab)
float
C3174092 (UMLS CUI [1])
Item
Size of tablets
text
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Code List
Size of tablets
Was dose vomited within 30 minutes?
Item
Was dose vomited within 30 minutes?
boolean
C0042963 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
receive breast milk or food
Item
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
boolean
C0006147 (UMLS CUI [1])
C0016452 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
Were tablets crushed?
Item
Were tablets crushed?
boolean
C0039225 (UMLS CUI [1,1])
C0185060 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT: IP REDOSE-CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO
C0304229 (UMLS CUI-1)
C0055470 (UMLS CUI-2)
C0010980 (UMLS CUI-3)
C0052432 (UMLS CUI-4)
C0032042 (UMLS CUI-5)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Dose (tab)
Item
Dose (tab)
float
C3174092 (UMLS CUI [1])
Item
Size of tablets
text
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Code List
Size of tablets
Was dose vomited within 30 minutes?
Item
Was dose vomited within 30 minutes?
boolean
C0042963 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
receive breast milk or food
Item
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
boolean
C0006147 (UMLS CUI [1])
C0016452 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
Were tablets crushed?
Item
Were tablets crushed?
boolean
C0039225 (UMLS CUI [1,1])
C0185060 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT FIRST DOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO
C0304229 (UMLS CUI-1)
C0052429 (UMLS CUI-2)
C0531104 (UMLS CUI-3)
C0032042 (UMLS CUI-5)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Dose (tab)
Item
Dose (tab)
float
C3174092 (UMLS CUI [1])
Was dose vomited within 30 minutes?
Item
Was dose vomited within 30 minutes?
boolean
C0042963 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
receive breast milk or food
Item
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
boolean
C0006147 (UMLS CUI [1])
C0016452 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
Were tablets crushed?
Item
Were tablets crushed?
boolean
C0039225 (UMLS CUI [1,1])
C0185060 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT SECOND DOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO
C0304229 (UMLS CUI-1)
C0052429 (UMLS CUI-2)
C0531104 (UMLS CUI-3)
C0032042 (UMLS CUI-4)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Dose (tab)
Item
Dose (tab)
float
C3174092 (UMLS CUI [1])
Was dose vomited within 30 minutes?
Item
Was dose vomited within 30 minutes?
boolean
C0042963 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
receive breast milk or food
Item
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
boolean
C0006147 (UMLS CUI [1])
C0016452 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
Were tablets crushed?
Item
Were tablets crushed?
boolean
C0039225 (UMLS CUI [1,1])
C0185060 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT FIRST IP REDOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO
C0304229 (UMLS CUI-1)
C0052429 (UMLS CUI-2)
C0531104 (UMLS CUI-3)
C0032042 (UMLS CUI-4)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Dose (tab)
Item
Dose (tab)
float
C3174092 (UMLS CUI [1])
Was dose vomited within 30 minutes?
Item
Was dose vomited within 30 minutes?
boolean
C0042963 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
receive breast milk or food
Item
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
boolean
C0006147 (UMLS CUI [1])
C0016452 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
Were tablets crushed?
Item
Were tablets crushed?
boolean
C0039225 (UMLS CUI [1,1])
C0185060 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT SECOND IP REDOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO
C0304229 (UMLS CUI-1)
C0052429 (UMLS CUI-2)
C0531104 (UMLS CUI-3)
C0032042 (UMLS CUI-4)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Dose (tab)
Item
Dose (tab)
float
C3174092 (UMLS CUI [1])
Was dose vomited within 30 minutes?
Item
Was dose vomited within 30 minutes?
boolean
C0042963 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
receive breast milk or food
Item
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
boolean
C0006147 (UMLS CUI [1])
C0016452 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
Were tablets crushed?
Item
Were tablets crushed?
boolean
C0039225 (UMLS CUI [1,1])
C0185060 (UMLS CUI [1,2])