ID

30556

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. 6/14/18 6/14/18 - Halim Ugurlu
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

June 14, 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 2.1 (Concominant Medications, Anti-Malarial Rescue Concominant Medications)

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
Concominant Medications
Description

Concominant Medications

Alias
UMLS CUI-1
C2347852
Were any concominant medications taken by the subject prior to screening and/or during the study?
Description

concominant medications

Data type

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2347852
Concominant Medications
Description

Concominant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Description

Unit Dose

Data type

float

Alias
UMLS CUI [1]
C0869039
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C0439148
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for medication
Description

Reason for medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
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
Taken prior to study?
Description

Taken prior to study

Data type

boolean

Alias
UMLS CUI [1]
C2826667
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
Ongoing Medication?
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Anti-Malarial Rescue Concominant Medications
Description

Anti-Malarial Rescue Concominant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2193813
Were any anti-malarial concominant medications taken by the subject during the study?
Description

anti-malarial concominant medications

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2193813
Anti-Malarial Rescue Concominant Medications
Description

Anti-Malarial Rescue Concominant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2193813
Drug Name
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Description

Unit Dose

Data type

float

Alias
UMLS CUI [1]
C0869039
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C0439148
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for medication
Description

Reason for medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
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
Ongoing Medication?
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Case Report From, Module Number 2.1 (Concominant Medications, Anti-Malarial Rescue Concominant Medications)

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
Concominant Medications
C2347852 (UMLS CUI-1)
concominant medications
Item
Were any concominant medications taken by the subject prior to screening and/or during the study?
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Concominant Medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
float
C0869039 (UMLS CUI [1])
Units
Item
Units
text
C0439148 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Reason for medication
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Taken prior to study
Item
Taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Item Group
Anti-Malarial Rescue Concominant Medications
C2347852 (UMLS CUI-1)
C2193813 (UMLS CUI-2)
anti-malarial concominant medications
Item
Were any anti-malarial concominant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C2193813 (UMLS CUI [1,2])
Item Group
Anti-Malarial Rescue Concominant Medications
C2347852 (UMLS CUI-1)
C2193813 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
float
C0869039 (UMLS CUI [1])
Units
Item
Units
text
C0439148 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Reason for medication
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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])
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
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