ID

30516

Description

https://clinicaltrials.gov/ct2/show/NCT00344006 Study ID : CDA 714703/005 Clinical Study ID :714703/005 Study Title :A multi-centre, randomised, double-blind, double dummy study comparing the efficacy and safety of chlorproguanil-dapsone-artesunate versus artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in children and adolescents in Africa. Patient Level Data : Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier : NCT00344006 Sponsor : GlaxoSmithKline Collaborators : N/A Phase phase :3 Study Recruitment Status : Completed Generic Name : artesunate/chlorproguanil/dapsone Trade Name : LAPDAP + ARTESUNATE Study Indication : Malaria, Falciparum

Link

https://clinicaltrials.gov/ct2/show/NCT00344006

Keywords

Versions (1)
  1. 6/11/18 6/11/18 - Halim Ugurlu
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

June 11, 2018

DOI

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License

Creative Commons BY-NC 3.0
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NCT00344006-Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria

English

Case Report From, Module Number 1.4 (Visits included in this module: Day 2)

1 forms  
Administrative Information
Description

Administrative Information

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Malaria Signs and Symptoms
Description

Malaria Signs and Symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C0024530
Chills and rigors
Description

Chills and rigors

Data type

text

Alias
UMLS CUI [1]
C0036973
Headache
Description

Headache

Data type

text

Alias
UMLS CUI [1]
C0018681
Dizziness
Description

Dizziness

Data type

text

Alias
UMLS CUI [1]
C0012833
Abdominal Pain
Description

Abdominal Pain

Data type

text

Alias
UMLS CUI [1]
C0000737
Anorexia
Description

Anorexia

Data type

text

Alias
UMLS CUI [1]
C0003123
Nausea
Description

Nausea

Data type

text

Alias
UMLS CUI [1]
C0027497
Vomiting
Description

Vomiting

Data type

text

Alias
UMLS CUI [1]
C0042963
Diarrhoea
Description

Diarrhoea

Data type

text

Alias
UMLS CUI [1]
C0011991
Pruritis/itching
Description

Pruritis/itching

Data type

text

Alias
UMLS CUI [1]
C0033774
Coughing
Description

Coughing

Data type

text

Alias
UMLS CUI [1]
C0010200
Other, specify
Description

Other, specify

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
Vital Signs-48 Hours Post First Dose (Pre-dose)
Description

Vital Signs-48 Hours Post First Dose (Pre-dose)

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Temperature
Description

Temperature

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0039476
C
Location of Temperature
Description

Location of Temperature

Data type

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
Vital Signs-56 Hours Post First Dose
Description

Vital Signs-56 Hours Post First Dose

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Temperature
Description

Temperature

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0039476
C
Location of Temperature
Description

Location of Temperature

Data type

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
Vital Signs-64 Hours Post First Dose
Description

Vital Signs-64 Hours Post First Dose

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Temperature
Description

Temperature

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0039476
C
Location of Temperature
Description

Location of Temperature

Data type

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 48 Hours Post First Dose
Description

MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 48 Hours Post First Dose

Alias
UMLS CUI-1
C3661511
UMLS CUI-2
C0024530
UMLS CUI-3
C0086960
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
P. falciparum Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032150
UMLS CUI [1,2]
C1254595
/UL
P. vivax Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032154
UMLS CUI [1,2]
C1254595
/UL
P. ovale Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0320744
UMLS CUI [1,2]
C1254595
/UL
P. malariae Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032153
UMLS CUI [1,2]
C1254595
/UL
Unknown Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0439673
UMLS CUI [1,2]
C1254595
/UL
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 56 Hours Post First Dose
Description

MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 56 Hours Post First Dose

Alias
UMLS CUI-1
C3661511
UMLS CUI-2
C0024530
UMLS CUI-3
C0086960
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
P. falciparum Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032150
UMLS CUI [1,2]
C1254595
/UL
P. vivax Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032154
UMLS CUI [1,2]
C1254595
/UL
P. ovale Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0320744
UMLS CUI [1,2]
C1254595
/UL
P. malariae Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032153
UMLS CUI [1,2]
C1254595
/UL
Unknown Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0439673
UMLS CUI [1,2]
C1254595
/UL
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 64 Hours Post First Dose
Description

MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 64 Hours Post First Dose

Alias
UMLS CUI-1
C3661511
UMLS CUI-2
C0024530
UMLS CUI-3
C0086960
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
P. falciparum Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032150
UMLS CUI [1,2]
C1254595
/UL
P. vivax Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032154
UMLS CUI [1,2]
C1254595
/UL
P. ovale Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0320744
UMLS CUI [1,2]
C1254595
/UL
P. malariae Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032153
UMLS CUI [1,2]
C1254595
/UL
Unknown Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0439673
UMLS CUI [1,2]
C1254595
/UL
GAMETOCYTE - SINGLE ASSESSMENT (48 HOURS POST FIRST DOSE)
Description

GAMETOCYTE - SINGLE ASSESSMENT (48 HOURS POST FIRST DOSE)

Alias
UMLS CUI-1
C0686869
UMLS CUI-2
C0220825
Species
Description

Species

Data type

integer

Alias
UMLS CUI [1]
C1705920
Result
Description

Result

Data type

text

Alias
UMLS CUI [1]
C1274040
Count /UL
Description

Count /UL

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1]
C0750480
/UL
LABORATORY RESULT DATA (HAEMATOLOGY)
Description

LABORATORY RESULT DATA (HAEMATOLOGY)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Laboratory name
Description

Laboratory name

Data type

text

Alias
UMLS CUI [1]
C3258037
Address
Description

Address

Data type

text

Alias
UMLS CUI [1]
C3262820
Date and time sample taken
Description

Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
WBC Result
Description

WBC Result

Data type

text

Alias
UMLS CUI [1]
C0023508
RBC Result
Description

RBC Result

Data type

text

Alias
UMLS CUI [1]
C1287262
Haemoglobin Result
Description

Haemoglobin Result

Data type

text

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C1274040
Haematocrit Result
Description

Haematocrit Result

Data type

text

Alias
UMLS CUI [1]
C0018935
Absolute Reticulocytes
Description

Absolute Reticulocytes

Data type

text

Alias
UMLS CUI [1]
C0206161
Reticulocytes (Percentage)
Description

Reticulocytes (Percentage)

Data type

text

Alias
UMLS CUI [1]
C1167975
Platelets
Description

Platelets

Data type

text

Alias
UMLS CUI [1]
C0005821
Methaemoglobin Result
Description

Methaemoglobin Result

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0025635
CONFIRMATION OF LABORATORY RESULTS
Description

CONFIRMATION OF LABORATORY RESULTS

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0750484
Has there been a drop of >=40% of baseline haemoglobin and/or blood transfusions, and/or haemoglobin values of <5g/dL?
Description

haemoglobin values

Data type

boolean

Alias
UMLS CUI [1]
C0518015
Is methaemoglobin >=20% or >= 10% but <20% with associated clinical symptoms of methaemoglobinaemia?
Description

methaemoglobinaemia

Data type

integer

Alias
UMLS CUI [1]
C0025637
PHARMACOKINETICS - PLASMA
Description

PHARMACOKINETICS - PLASMA

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0032105
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Description

Date Sample Taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Attach Sample Identifier Label Here
Description

Attach Sample Identifier Label Here

Data type

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
INVESTIGATIONAL PRODUCT: CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO
Description

INVESTIGATIONAL PRODUCT: CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0055470
UMLS CUI-3
C0010980
UMLS CUI-4
C0052432
UMLS CUI-6
C0032042
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Dose (tab)
Description

Dose (tab)

Data type

float

Alias
UMLS CUI [1]
C3174092
Size of tablets
Description

Size of tablets

Data type

text

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Was dose vomited within 30 minutes?
Description

Was dose vomited within 30 minutes?

Data type

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C3174092
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
Description

receive breast milk or food

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0016452
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0678766
Were tablets crushed?
Description

Were tablets crushed?

Data type

boolean

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0185060
INVESTIGATIONAL PRODUCT: IP REDOSE-CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO
Description

INVESTIGATIONAL PRODUCT: IP REDOSE-CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0055470
UMLS CUI-3
C0010980
UMLS CUI-4
C0052432
UMLS CUI-5
C0032042
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Dose (tab)
Description

Dose (tab)

Data type

float

Alias
UMLS CUI [1]
C3174092
Size of tablets
Description

Size of tablets

Data type

text

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Was dose vomited within 30 minutes?
Description

Was dose vomited within 30 minutes?

Data type

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C3174092
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
Description

receive breast milk or food

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0016452
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0678766
Were tablets crushed?
Description

Were tablets crushed?

Data type

boolean

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0185060
INVESTIGATIONAL PRODUCT FIRST DOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO
Description

INVESTIGATIONAL PRODUCT FIRST DOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0052429
UMLS CUI-3
C0531104
UMLS CUI-5
C0032042
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Dose (tab)
Description

Dose (tab)

Data type

float

Alias
UMLS CUI [1]
C3174092
Was dose vomited within 30 minutes?
Description

Was dose vomited within 30 minutes?

Data type

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C3174092
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
Description

receive breast milk or food

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0016452
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0678766
Were tablets crushed?
Description

Were tablets crushed?

Data type

boolean

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0185060
INVESTIGATIONAL PRODUCT SECOND DOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO
Description

INVESTIGATIONAL PRODUCT SECOND DOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0052429
UMLS CUI-3
C0531104
UMLS CUI-4
C0032042
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Dose (tab)
Description

Dose (tab)

Data type

float

Alias
UMLS CUI [1]
C3174092
Was dose vomited within 30 minutes?
Description

Was dose vomited within 30 minutes?

Data type

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C3174092
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
Description

receive breast milk or food

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0016452
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0678766
Were tablets crushed?
Description

Were tablets crushed?

Data type

boolean

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0185060
INVESTIGATIONAL PRODUCT FIRST IP REDOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO
Description

INVESTIGATIONAL PRODUCT FIRST IP REDOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0052429
UMLS CUI-3
C0531104
UMLS CUI-4
C0032042
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Dose (tab)
Description

Dose (tab)

Data type

float

Alias
UMLS CUI [1]
C3174092
Was dose vomited within 30 minutes?
Description

Was dose vomited within 30 minutes?

Data type

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C3174092
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
Description

receive breast milk or food

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0016452
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0678766
Were tablets crushed?
Description

Were tablets crushed?

Data type

boolean

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0185060
INVESTIGATIONAL PRODUCT SECOND IP REDOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO
Description

INVESTIGATIONAL PRODUCT SECOND IP REDOSE - ARTEMETHER-LUMEFANTRINE OR PLACEBO

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0052429
UMLS CUI-3
C0531104
UMLS CUI-4
C0032042
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Dose (tab)
Description

Dose (tab)

Data type

float

Alias
UMLS CUI [1]
C3174092
Was dose vomited within 30 minutes?
Description

Was dose vomited within 30 minutes?

Data type

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C3174092
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
Description

receive breast milk or food

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0016452
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0678766
Were tablets crushed?
Description

Were tablets crushed?

Data type

boolean

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0185060
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Similar models

Case Report From, Module Number 1.4 (Visits included in this module: Day 2)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Chills and rigors
Code List
Chills and rigors
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item
Headache
text
C0018681 (UMLS CUI [1])
Headache
Code List
Headache
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item
Dizziness
text
C0012833 (UMLS CUI [1])
Dizziness
Code List
Dizziness
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item
Abdominal Pain
text
C0000737 (UMLS CUI [1])
Abdominal Pain
Code List
Abdominal Pain
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item
Anorexia
text
C0003123 (UMLS CUI [1])
Anorexia
Code List
Anorexia
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item
Nausea
text
C0027497 (UMLS CUI [1])
Nausea
Code List
Nausea
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item
Vomiting
text
C0042963 (UMLS CUI [1])
Vomiting
Code List
Vomiting
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item
Diarrhoea
text
C0011991 (UMLS CUI [1])
Diarrhoea
Code List
Diarrhoea
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item
Pruritis/itching
text
C0033774 (UMLS CUI [1])
Pruritis/itching
Code List
Pruritis/itching
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item
Coughing
text
C0010200 (UMLS CUI [1])
Coughing
Code List
Coughing
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Other, specify
Code List
Other, specify
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
Item Group
Vital Signs-48 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])
Location of Temperature
Code List
Location of Temperature
CL Item
Axilla (1)
CL Item
Tympanic (2)
Item Group
Vital Signs-56 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])
Location of Temperature
Code List
Location of Temperature
CL Item
Axilla (1)
CL Item
Tympanic (2)
Item Group
Vital Signs-64 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])
Location of Temperature
Code List
Location of Temperature
CL Item
Axilla (1)
CL Item
Tympanic (2)
Item Group
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 48 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 - 56 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 - 64 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 (48 HOURS POST FIRST DOSE)
C0686869 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Item
Species
integer
C1705920 (UMLS CUI [1])
Species
Code List
Species
CL Item
P. falciparum (1)
CL Item
P. v i v a x (2)
CL Item
P. ovale (3)
CL Item
P. m a l a r i a e (4)
CL Item
Unknown (5)
Item
Result
text
C1274040 (UMLS CUI [1])
Result
Code List
Result
CL Item
Positive (POS)
CL Item
Negative (NEG)
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])
methaemoglobinaemia
Code List
Is methaemoglobin >=20% or >= 10% but <20% with associated clinical symptoms of methaemoglobinaemia?
CL Item
Yes (1)
CL Item
No (2)
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])
Planned Relative Time
Code List
Planned Relative Time
CL Item
0.25-0.5hrs (1)
CL Item
1-3hrs (2)
CL Item
4-8hrs (3)
CL Item
12-24hrs (4)
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])
Size of tablets
Code List
Size of tablets
CL Item
12/15/24 mg (1)
CL Item
60/75/120 mg (2)
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])
Size of tablets
Code List
Size of tablets
CL Item
12/15/24 mg (1)
CL Item
60/75/120 mg (2)
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])
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