ID

30525

Beschrijving

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

Trefwoorden

Versies (1)
  1. 11-06-18 11-06-18 - Halim Ugurlu
Houder van rechten

GlaxoSmithKline (GSK)

Geüploaded op

11 juni 2018

DOI

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Licentie

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

Engels

Case Report From, Module Number 1.9 (Visits included in this module: Day 28)

1 Formulieren  
Administrative Information
Beschrijving

Administrative Information

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

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

Malaria Signs and Symptoms

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

Chills and rigors

Datatype

text

Alias
UMLS CUI [1]
C0036973
Headache
Beschrijving

Headache

Datatype

text

Alias
UMLS CUI [1]
C0018681
Dizziness
Beschrijving

Dizziness

Datatype

text

Alias
UMLS CUI [1]
C0012833
Abdominal Pain
Beschrijving

Abdominal Pain

Datatype

text

Alias
UMLS CUI [1]
C0000737
Anorexia
Beschrijving

Anorexia

Datatype

text

Alias
UMLS CUI [1]
C0003123
Nausea
Beschrijving

Nausea

Datatype

text

Alias
UMLS CUI [1]
C0027497
Vomiting
Beschrijving

Vomiting

Datatype

text

Alias
UMLS CUI [1]
C0042963
Diarrhoea
Beschrijving

Diarrhoea

Datatype

text

Alias
UMLS CUI [1]
C0011991
Pruritis/itching
Beschrijving

Pruritis/itching

Datatype

text

Alias
UMLS CUI [1]
C0033774
Coughing
Beschrijving

Coughing

Datatype

text

Alias
UMLS CUI [1]
C0010200
Other, specify
Beschrijving

Other, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Sample Date and Time
Beschrijving

Sample Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • C
Alias
UMLS CUI [1]
C0039476
C
Location of Temperature
Beschrijving

Location of Temperature

Datatype

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
MALARIA PARASITOLOGY - SINGLE ASSESSMENT
Beschrijving

MALARIA PARASITOLOGY - SINGLE ASSESSMENT

Alias
UMLS CUI-1
C3661511
UMLS CUI-2
C0024530
UMLS CUI-3
C0086960
Sample Date and Time
Beschrijving

Sample Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
P. falciparum Results
Beschrijving

POS=Positive NEG=Negative

Datatype

text

Maateenheden
  • /UL
Alias
UMLS CUI [1,1]
C0032150
UMLS CUI [1,2]
C1254595
/UL
P. vivax Results
Beschrijving

POS=Positive NEG=Negative

Datatype

text

Maateenheden
  • /UL
Alias
UMLS CUI [1,1]
C0032154
UMLS CUI [1,2]
C1254595
/UL
P. ovale Results
Beschrijving

POS=Positive NEG=Negative

Datatype

text

Maateenheden
  • /UL
Alias
UMLS CUI [1,1]
C0320744
UMLS CUI [1,2]
C1254595
/UL
P. malariae Results
Beschrijving

POS=Positive NEG=Negative

Datatype

text

Maateenheden
  • /UL
Alias
UMLS CUI [1,1]
C0032153
UMLS CUI [1,2]
C1254595
/UL
Unknown Results
Beschrijving

POS=Positive NEG=Negative

Datatype

text

Maateenheden
  • /UL
Alias
UMLS CUI [1,1]
C0439673
UMLS CUI [1,2]
C1254595
/UL
GAMETOCYTE - SINGLE ASSESSMENT
Beschrijving

GAMETOCYTE - SINGLE ASSESSMENT

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

Species

Datatype

integer

Alias
UMLS CUI [1]
C1705920
Result
Beschrijving

Result

Datatype

text

Alias
UMLS CUI [1]
C1274040
Count /UL
Beschrijving

Count /UL

Datatype

text

Maateenheden
  • /UL
Alias
UMLS CUI [1]
C0750480
/UL
PCR Sample
Beschrijving

PCR Sample

Alias
UMLS CUI-1
C0032520
UMLS CUI-2
C0200345
Was a sample collected for P.F. PCR?
Beschrijving

PCR Sample

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032520
UMLS CUI [1,2]
C0200345
G6PD Repeat
Beschrijving

G6PD Repeat

Alias
UMLS CUI-1
C0391941
UMLS CUI-2
C0205341
Has a G6PD Phenotype Sample been taken?
Beschrijving

G6PD Phenotype Sample

Datatype

boolean

Alias
UMLS CUI [1,1]
C1333652
UMLS CUI [1,2]
C0031437
LABORATORY RESULT DATA (HAEMATOLOGY)
Beschrijving

LABORATORY RESULT DATA (HAEMATOLOGY)

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

Laboratory name

Datatype

text

Alias
UMLS CUI [1]
C3258037
Address
Beschrijving

Address

Datatype

text

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

Date and time sample taken

Datatype

datetime

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

WBC Result

Datatype

text

Alias
UMLS CUI [1]
C0023508
RBC Result
Beschrijving

RBC Result

Datatype

text

Alias
UMLS CUI [1]
C1287262
Haemoglobin Result
Beschrijving

Haemoglobin Result

Datatype

text

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

Haematocrit Result

Datatype

text

Alias
UMLS CUI [1]
C0018935
Absolute Reticulocytes
Beschrijving

Absolute Reticulocytes

Datatype

text

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

Reticulocytes (Percentage)

Datatype

text

Alias
UMLS CUI [1]
C1167975
Platelets
Beschrijving

Platelets

Datatype

text

Alias
UMLS CUI [1]
C0005821
Methaemoglobin Result
Beschrijving

Methaemoglobin Result

Datatype

text

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

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?
Beschrijving

haemoglobin values

Datatype

boolean

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

methaemoglobinaemia

Datatype

integer

Alias
UMLS CUI [1]
C0025637
LABORATORY RESULT DATA (Clinical Chemistry)
Beschrijving

LABORATORY RESULT DATA (Clinical Chemistry)

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
Was a lab sample taken?
Beschrijving

lab sample taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C3244292
UMLS CUI [1,2]
C1277698
Laboratory Name
Beschrijving

Laboratory Name

Datatype

text

Alias
UMLS CUI [1]
C3258037
Address
Beschrijving

Address

Datatype

text

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

Date and time sample taken

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
ALT Result
Beschrijving

ALT Result

Datatype

text

Alias
UMLS CUI [1]
C0201836
AST Result
Beschrijving

AST Result

Datatype

text

Alias
UMLS CUI [1]
C0201899
Total Bilirubin
Beschrijving

Total Bilirubin

Datatype

text

Alias
UMLS CUI [1]
C0201913
Indirect Bilirubin
Beschrijving

Indirect Bilirubin

Datatype

text

Alias
UMLS CUI [1]
C1881193
Creatinine
Beschrijving

Creatinine

Datatype

text

Alias
UMLS CUI [1]
C0201976
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Similar models

Case Report From, Module Number 1.9 (Visits included in this module: Day 28)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
C0518766 (UMLS CUI-1)
Sample Date and Time
Item
Sample Date and Time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
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 - SINGLE ASSESSMENT
C3661511 (UMLS CUI-1)
C0024530 (UMLS CUI-2)
C0086960 (UMLS CUI-3)
Sample Date and Time
Item
Sample Date and Time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
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
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
PCR Sample
C0032520 (UMLS CUI-1)
C0200345 (UMLS CUI-2)
PCR Sample
Item
Was a sample collected for P.F. PCR?
boolean
C0032520 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
G6PD Repeat
C0391941 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
G6PD Phenotype Sample
Item
Has a G6PD Phenotype Sample been taken?
boolean
C1333652 (UMLS CUI [1,1])
C0031437 (UMLS CUI [1,2])
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
LABORATORY RESULT DATA (Clinical Chemistry)
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
lab sample taken
Item
Was a lab sample taken?
boolean
C3244292 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
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])
ALT Result
Item
ALT Result
text
C0201836 (UMLS CUI [1])
AST Result
Item
AST Result
text
C0201899 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1])
Indirect Bilirubin
Item
Indirect Bilirubin
text
C1881193 (UMLS CUI [1])
Creatinine
Item
Creatinine
text
C0201976 (UMLS CUI [1])
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