Informações:
Falhas:
ID
30569
Descrição
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
Palavras-chave
Versões (1)
- 15/06/2018 15/06/2018 - Halim Ugurlu
Titular dos direitos
GlaxoSmithKline (GSK)
Transferido a
15 de junho de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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NCT00344006-Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Case Report From, Module Number 2.3 (Serious Adverse Event (SAE))
Similar models
Case Report From, Module Number 2.3 (Serious Adverse Event (SAE))
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
Section 1 - Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
serious adverse event during the study
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (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])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1])
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 Serious AE
text
C1704758 (UMLS CUI [1])
Code List
Action taken with Investigational Product(s) as a Result of the 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 SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Relationship to investigational Product(s)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
post-mortem/autopsy performed
Item
If fatal, was a post-mortem/autopsy performed? If yes, summerise findings in Section 11 Narrative remarks of this SAE form.
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 2 - Seriousness
C1828479 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
C1710056 (UMLS CUI-2)
Result in death
Item
Result in death
boolean
C1705232 (UMLS CUI [1])
Is life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
Requires hospitalisation or pronolongation of existing hospitalisation
Item
Requires hospitalisation or pronolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Other, specify
Item
Other, specify
text
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item Group
SECTION 3 - Demography Data
C1828479 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
C0011298 (UMLS CUI-2)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (Male)
CL Item
Female (Female)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
SECTION 4 - Reported Event(s) Recurrance
C1115086 (UMLS CUI-1)
Item
If Investigaional Product(s) was stopped, did the Reported Event(s) recur after investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
Code List
If Investigaional Product(s) was stopped, did the Reported Event(s) recur after investigational product(s) were administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
reported adverse event recur
Item
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occured, did the reported adverse event recur?
boolean
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
Item Group
SECTION 5 – Possible causes of SAE other than investigational product
C3828190 (UMLS CUI-1)
Disease under study
Item
Disease under study
boolean
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
Medical condition(s)
Item
Medical condition(s), specify
text
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,4])
Concominant medication(s)
Item
Concominant medication(s), specify
text
C2347852 (UMLS CUI [1])
Activity related to study participation
Item
Activity related to study participation (e.g., procedures)
boolean
C2348568 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Other
Item
Other, specify..
text
C0205394 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
SECTION 6 – Relevant Medical Conditions
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
RELEVANT past or current medical disorder
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C3899485 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C3899485 (UMLS CUI [1,3])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Condition present at the time of the SAE?
Item
Condition present at the time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Date of last Occurance
Item
If no, Date of last Occurance
date
C2745955 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
SECTION 7 – Other relevant risk factors
C0205394 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C1519255 (UMLS CUI-4)
C0035648 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C1519255 (UMLS CUI-4)
Family or social history relevant to the SAE
Item
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C0035648 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0028811 (UMLS CUI [1,3])
C0740858 (UMLS CUI [1,4])
C0241889 (UMLS CUI [1,2])
C0028811 (UMLS CUI [1,3])
C0740858 (UMLS CUI [1,4])
Item Group
SECTION 8 – Relevant Concomitant Medications
C3476109 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C2347852 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C0439148 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Taken prior to study
Item
Taken prior to study?
boolean
C2826667 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Ongoing medication
Item
Ongoing medication?
boolean
C2826666 (UMLS CUI [1])
Reason for medication
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Item Group
SECTION 9 – Details of investigational product(s)
C1828479 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
Blinded investigational product start date
Item
Blinded investigational product start date
date
C0808070 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
Blinded investigational product stop date
Item
Blinded investigational product stop date
date
C0806020 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational site?
text
C3897431 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C2347038 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item Group
SECTION 10 – Details of relevant assessments
C1261322 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI-2)
Details of RELEVANT Assessments
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 11 – Narrative remarks
C1828479 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI-2)
Narrative remarks
Item
Narrative remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C1828479 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
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 (print)
text
C2826892 (UMLS CUI [1])