ID

29750

Description

https://clinicaltrials.gov/show/NCT00197028 Seizures Report - Generalized convulsive Seizures Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

Link

https://clinicaltrials.gov/show/NCT00197028

Keywords

Versions (1)
  1. 4/18/18 4/18/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

April 18, 2018

DOI

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License

Creative Commons BY-NC 3.0
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RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028

English

Seizures Report - Generalized convulsive Seizures

1 forms  
Generalized convulsive Seizure
Description

Generalized convulsive Seizure

Alias
UMLS CUI-1
C0751494
UMLS CUI-2
C0205246
Witness of Seizure
Description

Witness of Seizure

Data type

integer

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0036572
Date of first generalized convulsive seizure:
Description

Date of first generalized convulsive seizure

Data type

date

Alias
UMLS CUI [1,1]
C0234533
UMLS CUI [1,2]
C0011008
Time of first generalized convulsive seizure:
Description

Time of first generalized convulsive seizure

Data type

time

Alias
UMLS CUI [1,1]
C0234533
UMLS CUI [1,2]
C0040223
Time of vaccination: (ONLY IF occurring on the day of vaccination or subsequent day)
Description

Time of vaccination

Data type

time

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0040223
History of fever at the time of the generalized convulsive seizure:
Description

Fever at the time of the generalized convulsive seizure

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0751494
Axillary temperature at the time of generalized convulsive seizure:
Description

Temperature at the time of generalized convulsive seizure

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0751494
UMLS CUI [1,3]
C0039476
°C
Duration of generalized convulsive seizure in minutes (approximately):
Description

(If intermittent occurrence, the time of the longest generalized convulsive seizure should be recorded)

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0751494
UMLS CUI [1,2]
C0449238
min
Number of generalized convulsive seizures:
Description

Number of generalized convulsive seizures

Data type

integer

Alias
UMLS CUI [1,1]
C0751494
UMLS CUI [1,2]
C0750480
Diagnostic certainty level: (*)
Description

(*) Clinical Assessment of Diagnostic Certainty Level 1 of diagnostic certainty witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty Not a case of generalized convulsive seizure

Data type

integer

Alias
UMLS CUI [1]
C0332146
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Similar models

Seizures Report - Generalized convulsive Seizures

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Generalized convulsive Seizure
C0751494 (UMLS CUI-1)
C0205246 (UMLS CUI-2)
Item
Witness of Seizure
integer
C0682356 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
Witness of Seizure
Code List
Witness of Seizure
CL Item
Witnessed by study personnel (1)
(Comment:en)
CL Item
Witnessed by parental history (2)
(Comment:en)
Date of first generalized convulsive seizure
Item
Date of first generalized convulsive seizure:
date
C0234533 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of first generalized convulsive seizure
Item
Time of first generalized convulsive seizure:
time
C0234533 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Time of vaccination
Item
Time of vaccination: (ONLY IF occurring on the day of vaccination or subsequent day)
time
C0042196 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Fever at the time of the generalized convulsive seizure
Item
History of fever at the time of the generalized convulsive seizure:
boolean
C0015967 (UMLS CUI [1,1])
C0751494 (UMLS CUI [1,2])
Temperature at the time of generalized convulsive seizure
Item
Axillary temperature at the time of generalized convulsive seizure:
float
C0015967 (UMLS CUI [1,1])
C0751494 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,3])
Duration of generalized convulsive seizure
Item
Duration of generalized convulsive seizure in minutes (approximately):
integer
C0751494 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Number of generalized convulsive seizures
Item
Number of generalized convulsive seizures:
integer
C0751494 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Diagnostic certainty level
Item
Diagnostic certainty level: (*)
integer
C0332146 (UMLS CUI [1])
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