ID

30616

Beschreibung

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

Stichworte

Versionen (1)
  1. 18.06.18 18.06.18 - Halim Ugurlu
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

18. Juni 2018

DOI

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Lizenz

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

Englisch

Case Report From, Module Number 2.5 (Unscheduled Visit-1)

1 Formulare  
Administrative Information
Beschreibung

Administrative Information

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

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

Malaria Signs and Symptoms

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

Chills and rigors

Datentyp

text

Alias
UMLS CUI [1]
C0036973
Headache
Beschreibung

Headache

Datentyp

text

Alias
UMLS CUI [1]
C0018681
Dizziness
Beschreibung

Dizziness

Datentyp

text

Alias
UMLS CUI [1]
C0012833
Abdominal Pain
Beschreibung

Abdominal Pain

Datentyp

text

Alias
UMLS CUI [1]
C0000737
Anorexia
Beschreibung

Anorexia

Datentyp

text

Alias
UMLS CUI [1]
C0003123
Nausea
Beschreibung

Nausea

Datentyp

text

Alias
UMLS CUI [1]
C0027497
Vomiting
Beschreibung

Vomiting

Datentyp

text

Alias
UMLS CUI [1]
C0042963
Diarrhoea
Beschreibung

Diarrhoea

Datentyp

text

Alias
UMLS CUI [1]
C0011991
Pruritis/itching
Beschreibung

Pruritis/itching

Datentyp

text

Alias
UMLS CUI [1]
C0033774
Coughing
Beschreibung

Coughing

Datentyp

text

Alias
UMLS CUI [1]
C0010200
Other, specify
Beschreibung

Other, specify

Datentyp

text

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Sample Date and Time
Beschreibung

Sample Date and Time

Datentyp

datetime

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

Temperature

Datentyp

float

Maßeinheiten
  • C
Alias
UMLS CUI [1]
C0039476
C
Location of Temperature
Beschreibung

Location of Temperature

Datentyp

integer

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

MALARIA PARASITOLOGY - SINGLE ASSESSMENT

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

Sample Date and Time

Datentyp

datetime

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

POS=Positive NEG=Negative

Datentyp

text

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

POS=Positive NEG=Negative

Datentyp

text

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

POS=Positive NEG=Negative

Datentyp

text

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

POS=Positive NEG=Negative

Datentyp

text

Maßeinheiten
  • /UL
Alias
UMLS CUI [1,1]
C0032153
UMLS CUI [1,2]
C1254595
/UL
Unknown Results
Beschreibung

POS=Positive NEG=Negative

Datentyp

text

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

GAMETOCYTE - SINGLE ASSESSMENT

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

Species

Datentyp

integer

Alias
UMLS CUI [1]
C1705920
Result
Beschreibung

Result

Datentyp

text

Alias
UMLS CUI [1]
C1274040
Count /UL
Beschreibung

Count /UL

Datentyp

text

Maßeinheiten
  • /UL
Alias
UMLS CUI [1]
C0750480
/UL
PCR Sample
Beschreibung

PCR Sample

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

PCR Sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032520
UMLS CUI [1,2]
C0200345
LABORATORY RESULT DATA (HAEMATOLOGY)
Beschreibung

LABORATORY RESULT DATA (HAEMATOLOGY)

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

Laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Address
Beschreibung

Address

Datentyp

text

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

Date and time sample taken

Datentyp

datetime

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

WBC Result

Datentyp

text

Alias
UMLS CUI [1]
C0023508
RBC Result
Beschreibung

RBC Result

Datentyp

text

Alias
UMLS CUI [1]
C1287262
Haemoglobin Result
Beschreibung

Haemoglobin Result

Datentyp

text

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

Haematocrit Result

Datentyp

text

Alias
UMLS CUI [1]
C0018935
Absolute Reticulocytes
Beschreibung

Absolute Reticulocytes

Datentyp

text

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

Reticulocytes (Percentage)

Datentyp

text

Alias
UMLS CUI [1]
C1167975
Platelets
Beschreibung

Platelets

Datentyp

text

Alias
UMLS CUI [1]
C0005821
Methaemoglobin Result
Beschreibung

Methaemoglobin Result

Datentyp

text

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

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?
Beschreibung

haemoglobin values

Datentyp

boolean

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

methaemoglobinaemia

Datentyp

integer

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

LABORATORY RESULT DATA (Clinical Chemistry)

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

lab sample taken

Datentyp

boolean

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

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Address
Beschreibung

Address

Datentyp

text

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

Date and time sample taken

Datentyp

datetime

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

ALT Result

Datentyp

text

Alias
UMLS CUI [1]
C0201836
AST Result
Beschreibung

AST Result

Datentyp

text

Alias
UMLS CUI [1]
C0201899
Total Bilirubin
Beschreibung

Total Bilirubin

Datentyp

text

Alias
UMLS CUI [1]
C0201913
Indirect Bilirubin
Beschreibung

Indirect Bilirubin

Datentyp

text

Alias
UMLS CUI [1]
C1881193
Creatinine
Beschreibung

Creatinine

Datentyp

text

Alias
UMLS CUI [1]
C0201976
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Ähnliche Modelle

Case Report From, Module Number 2.5 (Unscheduled Visit-1)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
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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