ID

30615

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 2.4 (Haematological Event Questionnaire)

1 Formulare  
Administrative Information
Beschreibung

Administrative Information

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Haematological Event Questionnaire
Beschreibung

Haematological Event Questionnaire

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0877248
UMLS CUI-3
C0279810
Does the subjects SAE involve a haematological event?
Beschreibung

If yes, complete the Haematological Event Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0279810
Description of Event
Beschreibung

Description of Event

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0678257
Event Date
Beschreibung

Event Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2745955
Did the subject experience any symptoms suggestive of a haematological disorder, prior to receiving study drug (e.g., dyspnoea, fatigue, pallor, etc.) ?
Beschreibung

Any symptoms prior to receiving study drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C3469597
If yes, provide the list of symptoms
Beschreibung

If yes, provide the list of symptoms

Datentyp

text

Alias
UMLS CUI [1]
C0037088
Did the subject experience any heamorrhaging?
Beschreibung

Did the subject experience any heamorrhaging?

Datentyp

boolean

Alias
UMLS CUI [1]
C0019080
If yes give the details of site
Beschreibung

If yes give the details of site

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0019080
Was the subject asymptomatic during the event?
Beschreibung

Was the subject asymptomatic during the event?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231221
UMLS CUI [1,2]
C1519255
If yes, how was the disorder detected?
Beschreibung

If yes, how was the disorder detected?

Datentyp

text

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0012634
Did the subject require a blood transfusion?
Beschreibung

require a blood transfusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C1514873
If yes, how many units?
Beschreibung

How many units of blood transfusion

Datentyp

text

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C1519795
Did the subject experience haemoglobinuria/haematuria?
Beschreibung

haemoglobinuria/haematuria

Datentyp

boolean

Alias
UMLS CUI [1]
C0018965
UMLS CUI [2]
C0019048
If yes, provide the details of laboratory data
Beschreibung

details of laboratory data

Datentyp

text

Alias
UMLS CUI [1]
C1254595
Diagnostic Tests: Please Send All Applicable
Beschreibung

Diagnostic Tests: Please Send All Applicable

Alias
UMLS CUI-1
C0086143
Please provide details of any additional laboratory investigations or examinations not captured within the standard CRF haematology or clinical chemistry pages (e.g. Proteinuria, Vitamin B12, Folate levels, Vitamin C deficiency, Biopsy, Stool Rectal Exam, etc.)
Beschreibung

details of any additional laboratory investigations or examinations

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0841577
Recent Medical History
Beschreibung

Recent Medical History

Alias
UMLS CUI-1
C0262926
Did the subject take any medication (including alternative or herbal remedies) over the preceding month?
Beschreibung

Subject take any medication (including alternative or herbal remedies) over the preceding month

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0025125
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0332152
If yes, provide details
Beschreibung

If yes, provide details

Datentyp

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C0013227
Has the subject been exposed to any toxic drugs or chemicals? (e.g. chloramphenicol or insecticides)
Beschreibung

exposed to any toxic drugs or chemicals

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3259004
UMLS CUI [1,2]
C0522757
UMLS CUI [1,3]
C0220806
If yes, provide details of toxic exposure
Beschreibung

details of toxic exposure

Datentyp

text

Alias
UMLS CUI [1,1]
C0522757
UMLS CUI [1,2]
C1522508
Has the subject developed an infection? (other than P.Falciparum malaria)
Beschreibung

developed an infection? (other than P.Falciparum malaria)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2359476
UMLS CUI [1,2]
C0009450
If yes, provide description
Beschreibung

If yes, provide description

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0009450
Is the HIV status of subject known?
Beschreibung

HIV status of subject

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
If yes, record details (if subject given consent)
Beschreibung

record details

Datentyp

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C0019699
If female, has the subject had a recent pregnancy?
Beschreibung

recent pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C2169591
If yes, provide details (i.e. date of birth of last child)
Beschreibung

provide details (i.e. date of birth of last child)

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0027361
UMLS CUI [1,5]
C0005615
Past Medical History
Beschreibung

Past Medical History

Alias
UMLS CUI-1
C3661816
Does the subject history of Blood loss (e.g. GI bleeding)?
Beschreibung

history of Blood loss

Datentyp

boolean

Alias
UMLS CUI [1]
C3163616
If yes, provide details (e.g. when diagnosed)
Beschreibung

provide details

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1522508
Previous blood transfusion?
Beschreibung

Previous blood transfusion?

Datentyp

boolean

Alias
UMLS CUI [1]
C0281867
If yes, provide details (e.g. when diagnosed)
Beschreibung

provide details

Datentyp

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C0281867
Neonatal jaundice?
Beschreibung

Neonatal jaundice

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022346
UMLS CUI [1,2]
C2939425
If yes, provide details (e.g. when diagnosed)
Beschreibung

provide details

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1522508
Other jaunderies (infection-induced or food-induced or durg-induced)?
Beschreibung

Other jaunderies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2010848
If yes, provide details (e.g. when diagnosed)
Beschreibung

provide details

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1522508
Sickle cell disease?
Beschreibung

Sickle cell disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0002895
If yes, provide details (e.g. when diagnosed)
Beschreibung

provide details

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1522508
Thalassaemia?
Beschreibung

Thalassaemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0039730
If yes, provide details (e.g. when diagnosed)
Beschreibung

provide details

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1522508
Extrinsic RBC defects?
Beschreibung

Extrinsic RBC defects

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002879
UMLS CUI [1,2]
C0002880
UMLS CUI [1,3]
C0272132
UMLS CUI [1,4]
C0852336
If yes, provide details (e.g. when diagnosed)
Beschreibung

provide details

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1522508
Porphyria?
Beschreibung

Porphyria

Datentyp

date

Alias
UMLS CUI [1]
C3463940
If yes, provide details (e.g. when diagnosed)
Beschreibung

provide details

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1522508
Family History
Beschreibung

Family History

Alias
UMLS CUI-1
C0241889
Is there a family history of Haemolysis/Jaundice
Beschreibung

family history of Haemolysis/Jaundice

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0022346
UMLS CUI [2]
C0019054
If yes, specify family member
Beschreibung

specify family member

Datentyp

text

Alias
UMLS CUI [1]
C0086282
G6PD Deficiency?
Beschreibung

G6PD Deficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C2939465
If yes, specify family member
Beschreibung

specify family member

Datentyp

text

Alias
UMLS CUI [1]
C0086282
Haemoglobinopathies?
Beschreibung

Haemoglobinopathies

Datentyp

boolean

Alias
UMLS CUI [1]
C0019045
If yes, specify family member
Beschreibung

specify family member

Datentyp

text

Alias
UMLS CUI [1]
C0086282
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Ähnliche Modelle

Case Report From, Module Number 2.4 (Haematological Event Questionnaire)

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])
Item Group
Haematological Event Questionnaire
C0034394 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0279810 (UMLS CUI-3)
SAE involve a haematological event
Item
Does the subjects SAE involve a haematological event?
boolean
C1519255 (UMLS CUI [1,1])
C0279810 (UMLS CUI [1,2])
Item Group
Description of Event
C0877248 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
Event Date
Item
Event Date
date
C0011008 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Any symptoms prior to receiving study drug
Item
Did the subject experience any symptoms suggestive of a haematological disorder, prior to receiving study drug (e.g., dyspnoea, fatigue, pallor, etc.) ?
boolean
C1457887 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
If yes, provide the list of symptoms
Item
If yes, provide the list of symptoms
text
C0037088 (UMLS CUI [1])
Did the subject experience any heamorrhaging?
Item
Did the subject experience any heamorrhaging?
boolean
C0019080 (UMLS CUI [1])
If yes give the details of site
Item
If yes give the details of site
text
C1515974 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
Was the subject asymptomatic during the event?
Item
Was the subject asymptomatic during the event?
boolean
C0231221 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
If yes, how was the disorder detected?
Item
If yes, how was the disorder detected?
text
C0205210 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
require a blood transfusion
Item
Did the subject require a blood transfusion?
boolean
C0005841 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
How many units of blood transfusion
Item
If yes, how many units?
text
C0005841 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
haemoglobinuria/haematuria
Item
Did the subject experience haemoglobinuria/haematuria?
boolean
C0018965 (UMLS CUI [1])
C0019048 (UMLS CUI [2])
details of laboratory data
Item
If yes, provide the details of laboratory data
text
C1254595 (UMLS CUI [1])
Item Group
Diagnostic Tests: Please Send All Applicable
C0086143 (UMLS CUI-1)
details of any additional laboratory investigations or examinations
Item
Please provide details of any additional laboratory investigations or examinations not captured within the standard CRF haematology or clinical chemistry pages (e.g. Proteinuria, Vitamin B12, Folate levels, Vitamin C deficiency, Biopsy, Stool Rectal Exam, etc.)
text
C0022885 (UMLS CUI [1,1])
C0841577 (UMLS CUI [1,2])
Item Group
Recent Medical History
C0262926 (UMLS CUI-1)
Subject take any medication (including alternative or herbal remedies) over the preceding month
Item
Did the subject take any medication (including alternative or herbal remedies) over the preceding month?
boolean
C2347852 (UMLS CUI [1,1])
C0025125 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
If yes, provide details
Item
If yes, provide details
text
C1522508 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
exposed to any toxic drugs or chemicals
Item
Has the subject been exposed to any toxic drugs or chemicals? (e.g. chloramphenicol or insecticides)
boolean
C3259004 (UMLS CUI [1,1])
C0522757 (UMLS CUI [1,2])
C0220806 (UMLS CUI [1,3])
details of toxic exposure
Item
If yes, provide details of toxic exposure
text
C0522757 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
developed an infection? (other than P.Falciparum malaria)
Item
Has the subject developed an infection? (other than P.Falciparum malaria)
boolean
C2359476 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
If yes, provide description
Item
If yes, provide description
text
C0678257 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
HIV status of subject
Item
Is the HIV status of subject known?
boolean
C0019699 (UMLS CUI [1])
record details
Item
If yes, record details (if subject given consent)
text
C1522508 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
recent pregnancy
Item
If female, has the subject had a recent pregnancy?
boolean
C2169591 (UMLS CUI [1])
provide details (i.e. date of birth of last child)
Item
If yes, provide details (i.e. date of birth of last child)
text
C0032961 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0027361 (UMLS CUI [1,4])
C0005615 (UMLS CUI [1,5])
Item Group
Past Medical History
C3661816 (UMLS CUI-1)
history of Blood loss
Item
Does the subject history of Blood loss (e.g. GI bleeding)?
boolean
C3163616 (UMLS CUI [1])
provide details
Item
If yes, provide details (e.g. when diagnosed)
text
C0012634 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Previous blood transfusion?
Item
Previous blood transfusion?
boolean
C0281867 (UMLS CUI [1])
provide details
Item
If yes, provide details (e.g. when diagnosed)
text
C1522508 (UMLS CUI [1,1])
C0281867 (UMLS CUI [1,2])
Neonatal jaundice
Item
Neonatal jaundice?
boolean
C0022346 (UMLS CUI [1,1])
C2939425 (UMLS CUI [1,2])
provide details
Item
If yes, provide details (e.g. when diagnosed)
text
C0012634 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Other jaunderies
Item
Other jaunderies (infection-induced or food-induced or durg-induced)?
boolean
C0205394 (UMLS CUI [1,1])
C2010848 (UMLS CUI [1,2])
provide details
Item
If yes, provide details (e.g. when diagnosed)
text
C0012634 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Sickle cell disease
Item
Sickle cell disease?
boolean
C0002895 (UMLS CUI [1])
provide details
Item
If yes, provide details (e.g. when diagnosed)
text
C0012634 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Thalassaemia
Item
Thalassaemia?
boolean
C0039730 (UMLS CUI [1])
provide details
Item
If yes, provide details (e.g. when diagnosed)
text
C0012634 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Extrinsic RBC defects
Item
Extrinsic RBC defects?
boolean
C0002879 (UMLS CUI [1,1])
C0002880 (UMLS CUI [1,2])
C0272132 (UMLS CUI [1,3])
C0852336 (UMLS CUI [1,4])
provide details
Item
If yes, provide details (e.g. when diagnosed)
text
C0012634 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Porphyria
Item
Porphyria?
date
C3463940 (UMLS CUI [1])
provide details
Item
If yes, provide details (e.g. when diagnosed)
text
C0012634 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Item Group
Family History
C0241889 (UMLS CUI-1)
family history of Haemolysis/Jaundice
Item
Is there a family history of Haemolysis/Jaundice
boolean
C0241889 (UMLS CUI [1,1])
C0022346 (UMLS CUI [1,2])
C0019054 (UMLS CUI [2])
specify family member
Item
If yes, specify family member
text
C0086282 (UMLS CUI [1])
G6PD Deficiency
Item
G6PD Deficiency?
boolean
C2939465 (UMLS CUI [1])
specify family member
Item
If yes, specify family member
text
C0086282 (UMLS CUI [1])
Haemoglobinopathies
Item
Haemoglobinopathies?
boolean
C0019045 (UMLS CUI [1])
specify family member
Item
If yes, specify family member
text
C0086282 (UMLS CUI [1])
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