ID

30555

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 2.0 (Investigational Product Discontinuation, Status of Treatment Blind, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature)

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
Investigational Product Discontinuation-Coartem or Placebo
Description

Investigational Product Discontinuation-Coartem or Placebo

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Was the investigational product stopped permanently before the end of the scheduled treatment period?
Description

investigational product stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0457454
If yes, select the primary reason the investigational product was stopped:
Description

if yes, select primary reason

Data type

text

Alias
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0566251
Investigational Product Discontinuation-Chlorproguanil-Dapsone-Artesunate or Placebo
Description

Investigational Product Discontinuation-Chlorproguanil-Dapsone-Artesunate or Placebo

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Was the investigational product stopped permanently before the end of the scheduled treatment period?
Description

investigational product stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0457454
If yes, select the primary reason the investigational product was stopped:
Description

if yes, select primary reason

Data type

text

Alias
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0566251
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Description

blind broken

Data type

boolean

Alias
UMLS CUI [1]
C3897431
Date blind broken
Description

If yes, complete the following

Data type

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason blind broken
Description

If yes, complete the following

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

Pregnancy Information

Data type

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1533716
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of study completion or withdrawal
Description

Date of study completion or withdrawal

Data type

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from study?
Description

Was the subject withdrawn from study?

Data type

boolean

Alias
UMLS CUI [1]
C0422727
If yes, select primary reason for withdrawal
Description

If yes, select primary reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0422727
Investigator Comment Log
Description

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF Page Number if applicable
Description

CRF Page Number if applicable

Data type

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Description

Investigator's Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator's Name
Description

Investigator's Name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Case Report From, Module Number 2.0 (Investigational Product Discontinuation, Status of Treatment Blind, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature)

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
Investigational Product Discontinuation-Coartem or Placebo
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
investigational product stopped
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
boolean
C0011008 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Item
If yes, select the primary reason the investigational product was stopped:
text
C1518544 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
if yes, select primary reason
Code List
If yes, select the primary reason the investigational product was stopped:
CL Item
Adverse Event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol Violation (3)
CL Item
Subject decided to withdraw from study (4)
CL Item
Other, specify (Z)
Item Group
Investigational Product Discontinuation-Chlorproguanil-Dapsone-Artesunate or Placebo
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
investigational product stopped
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
boolean
C0011008 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Item
If yes, select the primary reason the investigational product was stopped:
text
C1518544 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
if yes, select primary reason
Code List
If yes, select the primary reason the investigational product was stopped:
CL Item
Adverse Event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol Violation (3)
CL Item
Subject decided to withdraw from study (4)
CL Item
Other, specify (Z)
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
blind broken
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
If yes, complete the following
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
If yes, complete the following
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment. (1)
CL Item
Other, specify (2)
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
Pregnancy Information
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (not of childbearing potential or male) (X)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of study completion or withdrawal
Item
Date of study completion or withdrawal
date
C2983670 (UMLS CUI [1])
Was the subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
C0422727 (UMLS CUI [1])
Item
If yes, select primary reason for withdrawal
text
C0392360 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
If yes, select primary reason for withdrawal
Code List
If yes, select primary reason for withdrawal
CL Item
Adverse event (Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Other, specify... (Z)
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF Page Number if applicable
Item
CRF Page Number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator's Name
Item
Investigator's Name
text
C2826892 (UMLS CUI [1])
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