ID

41642

Description

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Seizures Report - Generalized Convulsive Seizures) is to be filled out whenever a seizure occurs. All generalized convulsive seizures captured 30 days post-vaccination will be reported as SAEs.

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Keywords

Versions (2)
  1. 12/1/20 12/1/20 -
  2. 12/5/20 12/5/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 1, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

English

Seizures Report - Generalized Convulsive Seizures

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Seizures Report
Description

Seizures Report

Alias
UMLS CUI-1
C0036572
UMLS CUI-2
C0684224
Witnessed by study personnel or Parental history?
Description

Witnessed by study personnel, Parental history

Data type

integer

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C2985653
UMLS CUI [2,1]
C0030551
UMLS CUI [2,2]
C1135957
Date of first generalized convulsive seizure
Description

Date of first generalized convulsive seizure

Data type

date

Alias
UMLS CUI [1,1]
C0205435
UMLS CUI [1,2]
C0751494
UMLS CUI [1,3]
C0205246
UMLS CUI [1,4]
C0011008
Time of first generalized convulsive seizure
Description

Time of first generalized convulsive seizure

Data type

time

Alias
UMLS CUI [1,1]
C0205435
UMLS CUI [1,2]
C0751494
UMLS CUI [1,3]
C0205246
UMLS CUI [1,4]
C0040223
Time of vaccination
Description

ONYL IF occurring on the day of vaccination or subsequent day

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

History of fever at the time of the generalized convulsive seizure

Data type

text

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0751494
UMLS CUI [1,3]
C0205246
Axillary temperature at the time of generalized convulsive seizure
Description

Axillary temperature at the time of generalized convulsive seizure

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0751494
UMLS CUI [1,2]
C0205246
UMLS CUI [1,3]
C1531924
°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
  • minutes
Alias
UMLS CUI [1,1]
C0751494
UMLS CUI [1,2]
C0205246
UMLS CUI [1,3]
C0449238
minutes
Number of generalized convulsive seizures
Description

Number of generalized convulsive seizures

Data type

integer

Alias
UMLS CUI [1,1]
C0751494
UMLS CUI [1,2]
C0205246
UMLS CUI [1,3]
C0449788
Diagnostic certainty level
Description

Diagnostic certainty level

Data type

integer

Alias
UMLS CUI [1,1]
C0332146
UMLS CUI [1,2]
C0751494
UMLS CUI [1,3]
C0205246
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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
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item Group
Seizures Report
C0036572 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
Item
Witnessed by study personnel or Parental history?
integer
C0682356 (UMLS CUI [1,1])
C2985653 (UMLS CUI [1,2])
C0030551 (UMLS CUI [2,1])
C1135957 (UMLS CUI [2,2])
Witnessed by study personnel, Parental history
Code List
Witnessed by study personnel or Parental history?
CL Item
Witnessed by study personnel (1)
CL Item
Parental history (2)
Date of first generalized convulsive seizure
Item
Date of first generalized convulsive seizure
date
C0205435 (UMLS CUI [1,1])
C0751494 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Time of first generalized convulsive seizure
Item
Time of first generalized convulsive seizure
time
C0205435 (UMLS CUI [1,1])
C0751494 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Time of vaccination
Item
Time of vaccination
time
C0042196 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
History of fever at the time of the generalized convulsive seizure
text
C0015967 (UMLS CUI [1,1])
C0751494 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
History of fever at the time of the generalized convulsive seizure
Code List
History of fever at the time of the generalized convulsive seizure
CL Item
Yes (Y)
CL Item
No (N)
Axillary temperature at the time of generalized convulsive seizure
Item
Axillary temperature at the time of generalized convulsive seizure
float
C0751494 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C1531924 (UMLS CUI [1,3])
Duration of generalized convulsive seizure in minutes
Item
Duration of generalized convulsive seizure in minutes (approximately)
integer
C0751494 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Number of generalized convulsive seizures
Item
Number of generalized convulsive seizures
integer
C0751494 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Item
Diagnostic certainty level
integer
C0332146 (UMLS CUI [1,1])
C0751494 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
Diagnostic certainty level
Code List
Diagnostic certainty level
CL Item
Level 1: witnessed sudden loss of consciousness AND generalized tonic, clonic, tonic-clonic, or atonic motor manifestations (1)
CL Item
Level 2: history of unconsciousness AND generalized tonic, clonic, tonic-clonic, or atonic motor manifestations (2)
CL Item
Level 3: history of unconsciousness AND other generalized motor manifestations (3)
CL Item
Level 4: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above (4)
CL Item
Level 5: Not a case of generalized convulsive seizure (5)
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