Informações:
Falhas:
ID
30493
Descrição
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
Palavras-chave
Versões (1)
- 08/06/2018 08/06/2018 - Halim Ugurlu
Titular dos direitos
GlaxoSmithKline (GSK)
Transferido a
8 de junho de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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NCT00344006-Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Case Report From, Module Number 1.3 (Visits included in this module: Day 1)
Similar models
Case Report From, Module Number 1.3 (Visits included in this module: Day 1)
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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)
C0024530 (UMLS CUI-2)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Unknown (U)
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])
C0039476 (UMLS CUI [1,2])
CL Item
Axilla (1)
CL Item
Tympanic (2)
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])
C0039476 (UMLS CUI [1,2])
CL Item
Axilla (1)
CL Item
Tympanic (2)
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])
C0039476 (UMLS CUI [1,2])
CL Item
Axilla (1)
CL Item
Tympanic (2)
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)
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])
C1254595 (UMLS CUI [1,2])
P. vivax Results
Item
P. vivax Results
text
C0032154 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
P. ovale Results
Item
P. ovale Results
text
C0320744 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
P. malariae Results
Item
P. malariae Results
text
C0032153 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
Unknown Results
Item
Unknown Results
text
C0439673 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
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)
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])
C1254595 (UMLS CUI [1,2])
P. vivax Results
Item
P. vivax Results
text
C0032154 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
P. ovale Results
Item
P. ovale Results
text
C0320744 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
P. malariae Results
Item
P. malariae Results
text
C0032153 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
Unknown Results
Item
Unknown Results
text
C0439673 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
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)
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])
C1254595 (UMLS CUI [1,2])
P. vivax Results
Item
P. vivax Results
text
C0032154 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
P. ovale Results
Item
P. ovale Results
text
C0320744 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
P. malariae Results
Item
P. malariae Results
text
C0032153 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
Unknown Results
Item
Unknown Results
text
C0439673 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
Item Group
GAMETOCYTE - SINGLE ASSESSMENT (24 HOURS POST FIRST DOSE)
C0686869 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
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)
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)
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])
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])
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])
C0025635 (UMLS CUI [1,2])
Item Group
CONFIRMATION OF LABORATORY RESULTS
C1254595 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
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
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item Group
PHARMACOKINETICS - PLASMA
C0031328 (UMLS CUI-1)
C0032105 (UMLS CUI-2)
C0032105 (UMLS CUI-2)
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])
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)
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])
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])
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])
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])
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)
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])
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])
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])
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])
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)
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])
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])
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])
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)
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])
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])
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])
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)
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])
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])
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])
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)
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])
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])
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])
C0185060 (UMLS CUI [1,2])