ID

30559

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. 14/6/18 14/6/18 - Halim Ugurlu
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

14 de junio de 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 2.2 (Non-Serious Adverse Event (AE))

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
Non-Serious Adverse Event (AE)
Beschreibung

Non-Serious Adverse Event (AE)

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse event during the study?
Beschreibung

If yes, record details below

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event (AE)
Beschreibung

Non-Serious Adverse Event (AE)

Alias
UMLS CUI-1
C1518404
Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Start Time
Beschreibung

Start Time

Datentyp

time

Alias
UMLS CUI [1]
C1301880
Outcome
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
End Date
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
End Time
Beschreibung

End Time

Datentyp

time

Alias
UMLS CUI [1]
C1522314
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C0439603
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschreibung

Action taken with Investigational Product(s)

Datentyp

text

Alias
UMLS CUI [1]
C1704758
Did the subject withdraw from study as a result of this AE?
Beschreibung

Withdrawal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship to investigational Product(s)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
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Ähnliche Modelle

Case Report From, Module Number 2.2 (Non-Serious Adverse Event (AE))

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
Non-Serious Adverse Event (AE)
C1518404 (UMLS CUI-1)
non-serious adverse event during the study
Item
Did the subject experience any non-serious adverse event during the study?
boolean
C1518404 (UMLS CUI [1])
Item Group
Non-Serious Adverse Event (AE)
C1518404 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1])
Item
Frequency
text
C0439603 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1704758 (UMLS CUI [1])
Action taken with Investigational Product(s)
Code List
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Relationship to investigational Product(s)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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