ID

30490

Descripción

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

Palabras clave

Versiones (1)
  1. 8/6/18 8/6/18 - Halim Ugurlu
Titular de derechos de autor

GlaxoSmithKline (GSK)

Subido en

8 de junio de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Case Report From, Module Number 1.2 (Visits included in this module: Day 0)

1 formularios  
Administrative Information
Descripción

Administrative Information

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

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

Malaria Signs and Symptoms

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

Chills and rigors

Tipo de datos

text

Alias
UMLS CUI [1]
C0036973
Headache
Descripción

Headache

Tipo de datos

text

Alias
UMLS CUI [1]
C0018681
Dizziness
Descripción

Dizziness

Tipo de datos

text

Alias
UMLS CUI [1]
C0012833
Abdominal Pain
Descripción

Abdominal Pain

Tipo de datos

text

Alias
UMLS CUI [1]
C0000737
Anorexia
Descripción

Anorexia

Tipo de datos

text

Alias
UMLS CUI [1]
C0003123
Nausea
Descripción

Nausea

Tipo de datos

text

Alias
UMLS CUI [1]
C0027497
Vomiting
Descripción

Vomiting

Tipo de datos

text

Alias
UMLS CUI [1]
C0042963
Diarrhoea
Descripción

Diarrhoea

Tipo de datos

text

Alias
UMLS CUI [1]
C0011991
Pruritis/itching
Descripción

Pruritis/itching

Tipo de datos

text

Alias
UMLS CUI [1]
C0033774
Coughing
Descripción

Coughing

Tipo de datos

text

Alias
UMLS CUI [1]
C0010200
Other, specify
Descripción

Other, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
Vital Signs-8 Hours Post First Dose
Descripción

Vital Signs-8 Hours Post First Dose

Alias
UMLS CUI-1
C0518766
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1]
C0039476
C
Location of Temperature
Descripción

Location of Temperature

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
Vital Signs-16 Hours Post First Dose
Descripción

Vital Signs-16 Hours Post First Dose

Alias
UMLS CUI-1
C0518766
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1]
C0039476
C
Location of Temperature
Descripción

Location of Temperature

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 8 Hours Post First Dose
Descripción

MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 8 Hours Post First Dose

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

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Descripción

Actual Time

Tipo de datos

time

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

POS=Positive NEG=Negative

Tipo de datos

text

Unidades de medida
  • /UL
Alias
UMLS CUI [1,1]
C0032150
UMLS CUI [1,2]
C1254595
/UL
P. vivax Results
Descripción

POS=Positive NEG=Negative

Tipo de datos

text

Unidades de medida
  • /UL
Alias
UMLS CUI [1,1]
C0032154
UMLS CUI [1,2]
C1254595
/UL
P. ovale Results
Descripción

POS=Positive NEG=Negative

Tipo de datos

text

Unidades de medida
  • /UL
Alias
UMLS CUI [1,1]
C0320744
UMLS CUI [1,2]
C1254595
/UL
P. malariae Results
Descripción

POS=Positive NEG=Negative

Tipo de datos

text

Unidades de medida
  • /UL
Alias
UMLS CUI [1,1]
C0032153
UMLS CUI [1,2]
C1254595
/UL
Unknown Results
Descripción

POS=Positive NEG=Negative

Tipo de datos

text

Unidades de medida
  • /UL
Alias
UMLS CUI [1,1]
C0439673
UMLS CUI [1,2]
C1254595
/UL
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 16 Hours Post First Dose
Descripción

MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 16 Hours Post First Dose

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

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Descripción

Actual Time

Tipo de datos

time

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

POS=Positive NEG=Negative

Tipo de datos

text

Unidades de medida
  • /UL
Alias
UMLS CUI [1,1]
C0032150
UMLS CUI [1,2]
C1254595
/UL
P. vivax Results
Descripción

POS=Positive NEG=Negative

Tipo de datos

text

Unidades de medida
  • /UL
Alias
UMLS CUI [1,1]
C0032154
UMLS CUI [1,2]
C1254595
/UL
P. ovale Results
Descripción

POS=Positive NEG=Negative

Tipo de datos

text

Unidades de medida
  • /UL
Alias
UMLS CUI [1,1]
C0320744
UMLS CUI [1,2]
C1254595
/UL
P. malariae Results
Descripción

POS=Positive NEG=Negative

Tipo de datos

text

Unidades de medida
  • /UL
Alias
UMLS CUI [1,1]
C0032153
UMLS CUI [1,2]
C1254595
/UL
Unknown Results
Descripción

POS=Positive NEG=Negative

Tipo de datos

text

Unidades de medida
  • /UL
Alias
UMLS CUI [1,1]
C0439673
UMLS CUI [1,2]
C1254595
/UL
INVESTIGATIONAL PRODUCT CONTAINER NUMBER
Descripción

INVESTIGATIONAL PRODUCT CONTAINER NUMBER

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Chlorproguanil-Dapsone-Artesunate or Placebo
Descripción

INVESTIGATIONAL PRODUCT CONTAINER NUMBER

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Artemether Lumefantrine or Placebo
Descripción

please write "Not applicable" if not applicable

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
INVESTIGATIONAL PRODUCT: CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO
Descripción

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
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Start Time
Descripción

Start Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Descripción

Stop Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Descripción

Stop Time

Tipo de datos

time

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

Dose (tab)

Tipo de datos

float

Alias
UMLS CUI [1]
C3174092
Size of tablets
Descripción

Size of tablets

Tipo de datos

text

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

Was dose vomited within 30 minutes?

Tipo de datos

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?
Descripción

receive breast milk or food

Tipo de datos

boolean

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

Were tablets crushed?

Tipo de datos

boolean

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

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
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Start Time
Descripción

Start Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Descripción

Stop Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Descripción

Stop Time

Tipo de datos

time

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

Dose (tab)

Tipo de datos

float

Alias
UMLS CUI [1]
C3174092
Size of tablets
Descripción

Size of tablets

Tipo de datos

text

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

Was dose vomited within 30 minutes?

Tipo de datos

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?
Descripción

receive breast milk or food

Tipo de datos

boolean

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

Were tablets crushed?

Tipo de datos

boolean

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

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
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Start Time
Descripción

Start Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Descripción

Stop Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Descripción

Stop Time

Tipo de datos

time

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

Dose (tab)

Tipo de datos

float

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

Was dose vomited within 30 minutes?

Tipo de datos

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?
Descripción

receive breast milk or food

Tipo de datos

boolean

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

Were tablets crushed?

Tipo de datos

boolean

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

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
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Start Time
Descripción

Start Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Descripción

Stop Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Descripción

Stop Time

Tipo de datos

time

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

Dose (tab)

Tipo de datos

float

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

Was dose vomited within 30 minutes?

Tipo de datos

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?
Descripción

receive breast milk or food

Tipo de datos

boolean

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

Were tablets crushed?

Tipo de datos

boolean

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

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
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Start Time
Descripción

Start Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Descripción

Stop Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Descripción

Stop Time

Tipo de datos

time

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

Dose (tab)

Tipo de datos

float

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

Was dose vomited within 30 minutes?

Tipo de datos

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?
Descripción

receive breast milk or food

Tipo de datos

boolean

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

Were tablets crushed?

Tipo de datos

boolean

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

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
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Start Time
Descripción

Start Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Descripción

Stop Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Descripción

Stop Time

Tipo de datos

time

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

Dose (tab)

Tipo de datos

float

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

Was dose vomited within 30 minutes?

Tipo de datos

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?
Descripción

receive breast milk or food

Tipo de datos

boolean

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

Were tablets crushed?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0185060
PHARMACOKINETICS - PLASMA
Descripción

PHARMACOKINETICS - PLASMA

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

Planned Relative Time

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Descripción

Date Sample Taken

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Descripción

Actual Time

Tipo de datos

time

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

Attach Sample Identifier Label Here

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
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Similar models

Case Report From, Module Number 1.2 (Visits included in this module: Day 0)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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-8 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-16 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 - 8 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 - 16 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
INVESTIGATIONAL PRODUCT CONTAINER NUMBER
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
INVESTIGATIONAL PRODUCT CONTAINER NUMBER
Item
Chlorproguanil-Dapsone-Artesunate or Placebo
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
INVESTIGATIONAL PRODUCT CONTAINER NUMBER
Item
Artemether Lumefantrine or Placebo
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
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])
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])
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