ID

29770

Description

https://clinicaltrials.gov/show/NCT00197028 Diary card, Adverse events 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

Diary card, Adverse events

1 forms  
Vaccination number
Description

Vaccination number

Alias
UMLS CUI-1
C1115464
UMLS CUI-2
C0042210
Vaccination number
Description

Vaccination number

Data type

integer

Alias
UMLS CUI [1,1]
C1115464
UMLS CUI [1,2]
C0042210
Adverse events - Local symptoms
Description

Adverse events - Local symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Swelling day
Description

Swelling day

Data type

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling size
Description

Swelling size

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Ongoing after Day 6?
Description

Swelling ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Pain day
Description

Pain day

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain intensity
Description

Pain intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Ongoing after Day 6?
Description

Pain ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Description - please specify side(s) and site(s)
Description

Other local symptoms

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Intensity
Description

Other local symptom intensity

Data type

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0518690
Local symptoms start date
Description

Start date

Data type

date

Alias
UMLS CUI [1]
C2697888
Local symptom end date
Description

End date

Data type

date

Alias
UMLS CUI [1]
C2697886
Check box if continuing
Description

Continuing local symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Trade/Generic name
Description

Please fill in below if any medication has been taken since the vaccination

Data type

text

Alias
UMLS CUI [1]
C2360065
Reason
Description

Reason for medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Total Daily Dose
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Start date
Description

Medication start date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Description

Medication end date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Check box if continuing
Description

Continuing medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Solicited adverse events - General symptoms
Description

Solicited adverse events - General symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Fever day
Description

Please record the temperature every day in the evening. If temperature has been taken more than once a day, please report the highest value for the day.

Data type

integer

Alias
UMLS CUI [1]
C0015967
Fever not taken?
Description

Fever not taken

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Fever temperature
Description

[A]> Axillary

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0015967
°C
Ongoing after Day 6?
Description

Ongoing fever

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015967
Irritability/ Fussiness day
Description

Irritability/ Fussiness day

Data type

boolean

Alias
UMLS CUI [1]
C0022107
Irritability/ Fussiness intensity
Description

Irritability/ Fussiness intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Ongoing after day 6?
Description

Irritability/ Fussiness ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022107
Drowsiness day
Description

Drowsiness day

Data type

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness intensity
Description

Drowsiness intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Ongoing after day 6?
Description

Drowsiness ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013144
Loss of appetite day
Description

Loss of appetite day

Data type

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite intensity
Description

Loss of appetite intensity

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Ongoing after Day 6?
Description

Loss of appetite ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1971624
Description - please give details below
Description

Other general symptoms

Data type

text

Alias
UMLS CUI [1]
C0029625
Intensity
Description

Other general symptom intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0518690
General symptoms start date
Description

Start date

Data type

date

Alias
UMLS CUI [1]
C2697888
General symptom end date
Description

End date

Data type

date

Alias
UMLS CUI [1]
C2697886
Check box if continuing
Description

Continuing general symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
Administative data
Description

Administative data

Alias
UMLS CUI-1
C1320722
Please do not forget to bring back diary card on:
Description

Diary card return

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C1548100
In case of hospitalization please inform: (Phone number)
Description

Contact person

Data type

integer

Alias
UMLS CUI [1,1]
C0337611
UMLS CUI [1,2]
C1515258
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Similar models

Diary card, Adverse events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vaccination number
C1115464 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Item
Vaccination number
integer
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccination number
Code List
Vaccination number
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
Item Group
Adverse events - Local symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Swelling day
integer
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling day
Code List
Swelling day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Swelling size
Item
Swelling size
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing
Item
Ongoing after Day 6?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Pain day
integer
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Pain day
Code List
Pain day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Item
Pain intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity
Code List
Pain intensity
CL Item
0: Absent (1)
CL Item
1: Minor reaction to touch (2)
CL Item
2: Cries/protests on touch (3)
CL Item
3: Cries when limb is moved / spontaneously painful (4)
Pain ongoing
Item
Ongoing after Day 6?
boolean
C0030193 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Other local symptoms
Item
Description - please specify side(s) and site(s)
text
C0205394 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Item
Intensity
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Other local symptom intensity
Code List
Intensity
CL Item
1:Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
2:Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
3:Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (3)
Start date
Item
Local symptoms start date
date
C2697888 (UMLS CUI [1])
End date
Item
Local symptom end date
date
C2697886 (UMLS CUI [1])
Continuing local symptoms
Item
Check box if continuing
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade/Generic name
Item
Trade/Generic name
text
C2360065 (UMLS CUI [1])
Reason for medication
Item
Reason
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication end date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Continuing medication
Item
Check box if continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Solicited adverse events - General symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Fever day
integer
C0015967 (UMLS CUI [1])
Fever day
Code List
Fever day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Fever not taken
Item
Fever not taken?
boolean
C0015967 (UMLS CUI [1])
Fever temperature
Item
Fever temperature
float
C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Ongoing fever
Item
Ongoing after Day 6?
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Irritability/ Fussiness day
Item
Irritability/ Fussiness day
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/ Fussiness intensity
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Irritability/ Fussiness intensity
Code List
Irritability/ Fussiness intensity
CL Item
0: Behavior as usual (1)
CL Item
1: Crying more than usual / no effect on normal activity (2)
CL Item
2: Crying more than usual / interferes with normal activity (3)
CL Item
3: Crying that cannot be comforted / prevents normal activity (4)
Irritability/ Fussiness ongoing
Item
Ongoing after day 6?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Item
Drowsiness day
integer
C0013144 (UMLS CUI [1])
Drowsiness day
Code List
Drowsiness day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Item
Drowsiness intensity
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Drowsiness intensity
Code List
Drowsiness intensity
CL Item
0:Behavior as usual (1)
CL Item
1:Drowsiness easily tolerated (2)
CL Item
2:Drowsiness that interferes with normal activity (3)
CL Item
3:Drowsiness that prevents normal activity (4)
Drowsiness ongoing
Item
Ongoing after day 6?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Item
Loss of appetite day
integer
C1971624 (UMLS CUI [1])
Loss of appetite day
Code List
Loss of appetite day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Item
Loss of appetite intensity
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite intensity
Code List
Loss of appetite intensity
CL Item
0: Appetite as usual (1)
CL Item
1: Eating less than usual / no effect on normal activity (2)
CL Item
2: Eating less than usual / interferes with normal activity (3)
CL Item
3: Not eating at all (4)
Loss of appetite ongoing
Item
Ongoing after Day 6?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Other general symptoms
Item
Description - please give details below
text
C0029625 (UMLS CUI [1])
Item
Intensity
integer
C0159028 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Other general symptom intensity
Code List
Intensity
CL Item
1:Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
2:Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
3:Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (3)
Start date
Item
General symptoms start date
date
C2697888 (UMLS CUI [1])
End date
Item
General symptom end date
date
C2697886 (UMLS CUI [1])
Continuing general symptoms
Item
Check box if continuing
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Administative data
C1320722 (UMLS CUI-1)
Diary card return
Item
Please do not forget to bring back diary card on:
date
C0011008 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
Contact person
Item
In case of hospitalization please inform: (Phone number)
integer
C0337611 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
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