ID

30569

Descripción

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

Palabras clave

Versiones (1)
  1. 15/6/18 15/6/18 - Halim Ugurlu
Titular de derechos de autor

GlaxoSmithKline (GSK)

Subido en

15 de junio de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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NCT00344006-Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria

Inglés

Case Report From, Module Number 2.3 (Serious Adverse Event (SAE))

1 formularios  
Administrative Information
Descripción

Administrative Information

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Descripción

Centre Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Randomisation Number
Descripción

Randomisation Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Section 1 - Serious Adverse Event (SAE)
Descripción

Section 1 - Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse event during the study?
Descripción

If yes, record details below

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event (SAE)
Descripción

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Event
Descripción

Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Start Time
Descripción

Start Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1301880
Outcome
Descripción

Outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
End Date
Descripción

If fatal, record date of death

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
End Time
Descripción

End Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1522314
Maximum Intensity
Descripción

Maximum Intensity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action taken with Investigational Product(s) as a Result of the Serious AE
Descripción

Action taken with Investigational Product(s)

Tipo de datos

text

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

Withdrawal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Descripción

Relationship to investigational Product(s)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Serious Adverse Event (SAE)
Descripción

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
If fatal, was a post-mortem/autopsy performed? If yes, summerise findings in Section 11 Narrative remarks of this SAE form.
Descripción

post-mortem/autopsy performed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
SECTION 2 - Seriousness
Descripción

SECTION 2 - Seriousness

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1710056
Result in death
Descripción

Result in death

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1705232
Is life-threatening
Descripción

Is life-threatening

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1517874
Requires hospitalisation or pronolongation of existing hospitalisation
Descripción

Requires hospitalisation or pronolongation of existing hospitalisation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0392360
Results in disability/incapacity
Descripción

Results in disability/incapacity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Congenital anomaly/birth defect
Descripción

Congenital anomaly/birth defect

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0877248
Other, specify
Descripción

(see definition of SAE)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205394
SECTION 3 - Demography Data
Descripción

SECTION 3 - Demography Data

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0011298
Date of Birth
Descripción

Date of Birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Sex
Descripción

Sex

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Weight
Descripción

Weight

Tipo de datos

float

Alias
UMLS CUI [1]
C0005910
SECTION 4 - Reported Event(s) Recurrance
Descripción

SECTION 4 - Reported Event(s) Recurrance

Alias
UMLS CUI-1
C1115086
If Investigaional Product(s) was stopped, did the Reported Event(s) recur after investigational product(s) were administered?
Descripción

Reported Event recur after investigational product(s) were administered

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C3469597
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occured, did the reported adverse event recur?
Descripción

reported adverse event recur

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0034897
SECTION 5 – Possible causes of SAE other than investigational product
Descripción

SECTION 5 – Possible causes of SAE other than investigational product

Alias
UMLS CUI-1
C3828190
Disease under study
Descripción

Disease under study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0012634
Medical condition(s), specify
Descripción

Medical condition(s)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0009488
Lack of efficacy
Descripción

Lack of efficacy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0235828
Withdrawal of investigational product(s)
Descripción

Withdrawal of investigational product(s)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C2349954
Concominant medication(s), specify
Descripción

Concominant medication(s)

Tipo de datos

text

Alias
UMLS CUI [1]
C2347852
Activity related to study participation (e.g., procedures)
Descripción

Activity related to study participation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Other, specify..
Descripción

Other

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
SECTION 6 – Relevant Medical Conditions
Descripción

SECTION 6 – Relevant Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0262926
UMLS CUI-3
C1519255
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Descripción

RELEVANT past or current medical disorder

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C3899485
Date of Onset
Descripción

Date of Onset

Tipo de datos

date

Alias
UMLS CUI [1]
C0574845
Condition present at the time of the SAE?
Descripción

Condition present at the time of the SAE?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If no, Date of last Occurance
Descripción

Date of last Occurance

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
SECTION 7 – Other relevant risk factors
Descripción

SECTION 7 – Other relevant risk factors

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C0035648
UMLS CUI-3
C2347946
UMLS CUI-4
C1519255
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
Descripción

Family or social history relevant to the SAE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0241889
UMLS CUI [1,3]
C0028811
UMLS CUI [1,4]
C0740858
SECTION 8 – Relevant Concomitant Medications
Descripción

SECTION 8 – Relevant Concomitant Medications

Alias
UMLS CUI-1
C3476109
UMLS CUI-2
C2347852
UMLS CUI-3
C1519255
Drug name
Descripción

Trade name preferred

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Dose
Descripción

Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C3174092
Unit
Descripción

Unit

Tipo de datos

text

Alias
UMLS CUI [1]
C0439148
Frequency
Descripción

Frequency

Tipo de datos

text

Alias
UMLS CUI [1]
C3476109
Route
Descripción

Route

Tipo de datos

text

Alias
UMLS CUI [1]
C0013153
Taken prior to study?
Descripción

Taken prior to study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826667
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Stop Date
Descripción

Stop Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
Ongoing medication?
Descripción

Ongoing medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
Reason for medication
Descripción

Reason for medication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
SECTION 9 – Details of investigational product(s)
Descripción

SECTION 9 – Details of investigational product(s)

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0304229
Blinded investigational product start date
Descripción

Blinded investigational product start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013230
Blinded investigational product stop date
Descripción

Blinded investigational product stop date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013230
Was treatment blind broken at investigational site?
Descripción

Blind broken at investigational site

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C2347038
SECTION 10 – Details of relevant assessments
Descripción

SECTION 10 – Details of relevant assessments

Alias
UMLS CUI-1
C1261322
UMLS CUI-2
C1519255
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)
Descripción

Details of RELEVANT Assessments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
SECTION 11 – Narrative remarks
Descripción

SECTION 11 – Narrative remarks

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0947611
Narrative remarks (provide a brief narrative description of the SAE and details of treatment given)
Descripción

Narrative remarks

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1828479
UMLS CUI [1,2]
C0947611
Investigator's Signature
Descripción

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Descripción

Investigator's Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Investigator's Name (print)
Descripción

Investigator's Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Case Report From, Module Number 2.3 (Serious Adverse Event (SAE))

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Information
C1320722 (UMLS CUI-1)
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])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
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])
Item Group
Serious Adverse Event (SAE)
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])
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)
CL Item
Fatal (5)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C1519255 (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 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 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])
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])
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
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])
Item Group
SECTION 2 - Seriousness
C1828479 (UMLS CUI-1)
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])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
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])
Other, specify
Item
Other, specify
text
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
SECTION 3 - Demography Data
C1828479 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
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])
Reported Event recur after investigational product(s) were administered
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])
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])
Medical condition(s)
Item
Medical condition(s), specify
text
C1547657 (UMLS CUI [1,1])
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])
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])
Other
Item
Other, specify..
text
C0205394 (UMLS CUI [1,1])
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)
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])
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])
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])
Item Group
SECTION 7 – Other relevant risk factors
C0205394 (UMLS CUI-1)
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])
Item Group
SECTION 8 – Relevant Concomitant Medications
C3476109 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1,1])
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])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
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])
Item Group
SECTION 9 – Details of investigational product(s)
C1828479 (UMLS CUI-1)
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])
Blinded investigational product stop date
Item
Blinded investigational product stop date
date
C0806020 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational site?
text
C3897431 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Blind broken at investigational site
Code List
Was treatment blind broken at investigational site?
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)
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])
Item Group
SECTION 11 – Narrative remarks
C1828479 (UMLS CUI-1)
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])
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 (print)
text
C2826892 (UMLS CUI [1])
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