ID

37971

Description

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains the Diary Cards, in which parents/guardians should record local and general symptoms in the first 3 days after the study vaccinations, as well as medication taken since the vaccination. These forms are handed out after the vaccination Visits, i.e. Visits 1, 2, 3 and 8 (all cohorts) and additionally Visit 5 for all cohorts except for the 3+0 schedule without the booster vaccination in HIV-negative subjects. These Diary Cards are transcribed by the investigator, resulting in the Solicited/Unsolicited AE form as well as (part of) the Concomitant Medication form.

Keywords

Versions (2)
  1. 9/2/19 9/2/19 -
  2. 9/3/19 9/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 3, 2019

DOI

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License

Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010

English

Diary Cards (Amendment 1)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Dose preceding assessment
Description

This selection depends on the cohort: Cohorts 1 (HIV-pos.), 2 (HIV-neg., exposed) and 3 (HIV-neg. unexposed, 3+1 schedule) receive all the vaccinations listed as options 1 through to 5 at Visits 1, 2, 3, 5 and 8. Cohort 4 (HIV-neg. unexposed, 3+0 schedule) receives the vaccinations listed as options 1, 2, 3 and 5 at Visits 1, 2, 3 and 8 (i.e. no Booster Dose of 10PN-PD-DIT at Visit 5 (Age 9-10 Months)). Cohort 5 (HIV-neg. unexposed, 2+1 schedule) receives the vaccinations listed as options 1, 6, 7, 4, and 5 at Visits 1, 2, 3, 5 and 8 (i.e. no second dose of 10PN-PD-DIT at Visit 2 (± 10 Weeks)).

Data type

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0220825
Day 0 = date of vaccination
Description

Date of vaccination

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Please do not forget to bring back the diary card on
Description

Diary Card Return Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C1548100
In case of hospitalization, please inform
Description

Investigator/Contact Name

Data type

text

Alias
UMLS CUI [1]
C2826892
In case of hospitalization, please inform (Phone number)
Description

Investigator/Contact Phone number

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1515258
Local Symptoms (at injection sites)
Description

Local Symptoms (at injection sites)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C2700396
Select vaccination
Description

Fill in entire item group once per vaccine The 10Pn-PD-DiT vaccine is administered at Visits 1 (all cohorts), 2 (all cohorts except the 2+1 schedule HIV-neg. cohort), 3 (all cohorts) and 5 (all cohorts except the EPI/3+0 schedule HIV-neg. cohort). The DTPw-HBV/Hib vaccine is administered at Visits 1, 2, 3 and 8 (all cohorts).

Data type

integer

Alias
UMLS CUI [1]
C0042196
Vaccine Administration Side
Description

For investigator only: Could you please tick the appropriate box (side / site) for assessment.

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Vaccine Administration Site
Description

For investigator only: Could you please tick the appropriate box (side / site) for assessment.

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Select symptom
Description

Fill in entire item group once per symptom Record either Size on Days 0-3 for Redness and Swelling or Pain Intensity on Days 0-3 for Pain.

Data type

integer

Alias
UMLS CUI [1]
C1457887
Size Day 0
Description

for Redness and Swelling Measure and record the greatest diameter (in mm). The original PDF file contains a printed 0-100 mm scale. The following comment is included in the Diary Cards of the Booster Doses: In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0456389
mm
Size Day 1
Description

for Redness and Swelling Measure and record the greatest diameter (in mm). The original PDF file contains a printed 0-100 mm scale. The following comment is included in the Diary Cards of the Booster Doses: In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0456389
mm
Size Day 2
Description

for Redness and Swelling Measure and record the greatest diameter (in mm). The original PDF file contains a printed 0-100 mm scale. The following comment is included in the Diary Cards of the Booster Doses: In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0456389
mm
Size Day 3
Description

for Redness and Swelling Measure and record the greatest diameter (in mm). The original PDF file contains a printed 0-100 mm scale. The following comment is included in the Diary Cards of the Booster Doses: In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0456389
mm
Pain intensity Day 0
Description

Intensity: 0 / 1 / 2 / 3

Data type

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 1
Description

Intensity: 0 / 1 / 2 / 3

Data type

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 2
Description

Intensity: 0 / 1 / 2 / 3

Data type

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 3
Description

Intensity: 0 / 1 / 2 / 3

Data type

integer

Alias
UMLS CUI [1]
C1320357
Symptom ongoing after Day 3?
Description

if yes, give last day of symptoms in next item

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
If Symptom is ongoing after Day 3, record date of last Day of Symptoms
Description

Last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Other local symptoms
Description

Other local symptoms

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Description - please specify side(s) and site(s)
Description

Local symptom description

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0678257
Symptom Intensity
Description

Symptom Intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
Symptom start date
Description

Symptom start date

Data type

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0808070
Symptom continuing?
Description

If no, record end date

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
Symptom end date
Description

if not continuing

Data type

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0806020
General Symptoms
Description

General Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0042196
Select symptom
Description

Fill in entire item group once per symptom Diarrhoea and Vomiting are only applicable if HRV has been administered (Visit 2 and 3)

Data type

integer

Alias
UMLS CUI [1]
C1457887
Site of temperature measurement
Description

Please record the temperature every day in the evening. Should additional temperature measurements be performed at other times of the day, the highest temperature is to be recorded.

Data type

text

Alias
UMLS CUI [1]
C0489453
Body Temperature on Day 0
Description

Body Temperature on Day 0

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0005903
C
Body Temperature on Day 1
Description

Body Temperature on Day 1

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0005903
C
Body Temperature on Day 2
Description

Body Temperature on Day 2

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0005903
C
Body Temperature on Day 3
Description

Body Temperature on Day 3

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0005903
C
Symptom Intensity on Day 0
Description

For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all

Data type

integer

Alias
UMLS CUI [1]
C0518690
Symptom Intensity on Day 1
Description

For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all

Data type

integer

Alias
UMLS CUI [1]
C0518690
Symptom Intensity on Day 2
Description

For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all

Data type

integer

Alias
UMLS CUI [1]
C0518690
Symptom Intensity on Day 3
Description

For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all

Data type

integer

Alias
UMLS CUI [1]
C0518690
Number of episodes on Day 0
Description

For Diarrhoea, record the number of looser than normal stools per day. For Vomiting, record the number of vomiting episodes per day.

Data type

integer

Alias
UMLS CUI [1,1]
C0750480
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0439505
Number of episodes on Day 1
Description

For Diarrhoea, record the number of looser than normal stools per day. For Vomiting, record the number of vomiting episodes per day.

Data type

integer

Alias
UMLS CUI [1,1]
C0750480
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0439505
Number of episodes on Day 2
Description

For Diarrhoea, record the number of looser than normal stools per day. For Vomiting, record the number of vomiting episodes per day.

Data type

integer

Alias
UMLS CUI [1,1]
C0750480
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0439505
Number of episodes on Day 3
Description

For Diarrhoea, record the number of looser than normal stools per day. For Vomiting, record the number of vomiting episodes per day.

Data type

integer

Alias
UMLS CUI [1,1]
C0750480
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0439505
Symptom ongoing after Day 3?
Description

if yes, give last day of symptoms in next item

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
If Symptom is ongoing after Day 3, record date of last Day of Symptoms
Description

Last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Other General Symptoms
Description

Other General Symptoms

Alias
UMLS CUI-1
C0029625
Description - please give details
Description

General symptom description

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0678257
Symptom Intensity
Description

Symptom Intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
Symptom start date
Description

Symptom start date

Data type

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0808070
Symptom continuing?
Description

If no, record end date

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
Symptom end date
Description

if not continuing

Data type

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0806020
Medication
Description

Medication

Alias
UMLS CUI-1
C2347852
Trade/Generic name
Description

Concomitant Medication name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Concomitant Medication Reason
Description

Concomitant Medication Reason

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2347852
Total Daily Dose
Description

Concomitant Medication Daily Dose

Data type

text

Alias
UMLS CUI [1]
C2826638
Start date
Description

Concomitant Medication start date

Data type

date

Alias
UMLS CUI [1]
C2826734
End date
Description

if not continuing

Data type

date

Alias
UMLS CUI [1]
C2826744
Medication continuing?
Description

If no, specify end date

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Diary Cards (Amendment 1)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Item
Dose preceding assessment
integer
C3174092 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Dose
Code List
Dose preceding assessment
CL Item
Dose 1, Age ± 6 weeks (1)
CL Item
Dose 2 DTPW-HBV/HIB and 10PN-PD-DIT, Dose 1 HRV, Age ± 10 Weeks (2)
CL Item
Dose 3 DTPW-HBV/HIB and 10PN-PD-DIT, Dose 2 HRV, Age ± 14 Weeks (3)
CL Item
Booster Dose 10PN-PD-DIT, Age 9-10 Months (4)
CL Item
Booster Dose DTPW-HBV/HIB, Age 15-18 Months (5)
CL Item
Dose 2 DTPW-HBV/HIB, Dose 1 HRV, Age ± 10 weeks (6)
CL Item
Dose 2 10-PN-PD-DIT and HRV, Dose 3 DTPW-HBV/HIB, Age ± 14 Weeks (7)
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Diary Card Return Date
Item
Please do not forget to bring back the diary card on
date
C0011008 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C1548100 (UMLS CUI [1,3])
Investigator/Contact Name
Item
In case of hospitalization, please inform
text
C2826892 (UMLS CUI [1])
Investigator/Contact Phone number
Item
In case of hospitalization, please inform (Phone number)
text
C0008961 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Item Group
Local Symptoms (at injection sites)
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
Item
Select vaccination
integer
C0042196 (UMLS CUI [1])
Select vaccination
Code List
Select vaccination
CL Item
10Pn-PD-DiT Vaccine (1)
CL Item
DTPw-HBV/Hib Vaccine (2)
Item
Vaccine Administration Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine Administration Side
Code List
Vaccine Administration Side
CL Item
Left (L)
CL Item
Right (R)
Item
Vaccine Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine Administration Side
Code List
Vaccine Administration Site
CL Item
Deltoid (D)
CL Item
Thigh (T)
CL Item
Buttocks (B)
Item
Select symptom
integer
C1457887 (UMLS CUI [1])
Select vaccination
Code List
Select symptom
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Size Day 0
Item
Size Day 0
integer
C0456389 (UMLS CUI [1])
Size Day 1
Item
Size Day 1
integer
C0456389 (UMLS CUI [1])
Size Day 2
Item
Size Day 2
integer
C0456389 (UMLS CUI [1])
Size Day 3
Item
Size Day 3
integer
C0456389 (UMLS CUI [1])
Item
Pain intensity Day 0
integer
C1320357 (UMLS CUI [1])
Pain intensity Day 0
Code List
Pain intensity Day 0
CL Item
Minor reaction to touch (1)
CL Item
Cries / protests on touch (2)
CL Item
Cries when limb is moved / spontaneously painful (3)
CL Item
Absent (0)
Item
Pain intensity Day 1
integer
C1320357 (UMLS CUI [1])
Pain intensity Day 0
Code List
Pain intensity Day 1
CL Item
Minor reaction to touch (1)
CL Item
Cries / protests on touch (2)
CL Item
Cries when limb is moved / spontaneously painful (3)
CL Item
Absent (0)
Item
Pain intensity Day 2
integer
C1320357 (UMLS CUI [1])
Pain intensity Day 0
Code List
Pain intensity Day 2
CL Item
Minor reaction to touch (1)
CL Item
Cries / protests on touch (2)
CL Item
Cries when limb is moved / spontaneously painful (3)
CL Item
Absent (0)
Item
Pain intensity Day 3
integer
C1320357 (UMLS CUI [1])
Pain intensity Day 0
Code List
Pain intensity Day 3
CL Item
Minor reaction to touch (1)
CL Item
Cries / protests on touch (2)
CL Item
Cries when limb is moved / spontaneously painful (3)
CL Item
Absent (0)
Symptom ongoing after Day 3?
Item
Symptom ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Last Day of Symptoms
Item
If Symptom is ongoing after Day 3, record date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Other local symptoms
C0205394 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Local symptom description
Item
Description - please specify side(s) and site(s)
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Symptom Intensity
integer
C0518690 (UMLS CUI [1])
Symptom Intensity
Code List
Symptom Intensity
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
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)
Symptom start date
Item
Symptom start date
date
C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Symptom continuing?
Item
Symptom continuing?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Symptom end date
Item
Symptom end date
date
C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
General Symptoms
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Select symptom
integer
C1457887 (UMLS CUI [1])
Select vaccination
Code List
Select symptom
CL Item
Temperature (1)
CL Item
Irritability/Fussiness (2)
CL Item
Drowsiness (3)
CL Item
Loss of appetite (4)
CL Item
Diarrhoea (5)
CL Item
Vomiting (6)
Item
Site of temperature measurement
text
C0489453 (UMLS CUI [1])
Site of measurement
Code List
Site of temperature measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
CL Item
Tympanic (oral conversion) (X)
CL Item
Tympanic (rectal conversion) (Y)
Body Temperature on Day 0
Item
Body Temperature on Day 0
float
C0005903 (UMLS CUI [1])
Body Temperature on Day 1
Item
Body Temperature on Day 1
float
C0005903 (UMLS CUI [1])
Body Temperature on Day 2
Item
Body Temperature on Day 2
float
C0005903 (UMLS CUI [1])
Body Temperature on Day 3
Item
Body Temperature on Day 3
float
C0005903 (UMLS CUI [1])
Item
Symptom Intensity on Day 0
integer
C0518690 (UMLS CUI [1])
Pain
Code List
Symptom Intensity on Day 0
CL Item
Behavior as usual (0)
CL Item
Symptom easily tolerated / no effect on normal activity (1)
CL Item
Symptom interferes with normal activity (2)
CL Item
Symptom prevents normal activity (3)
Item
Symptom Intensity on Day 1
integer
C0518690 (UMLS CUI [1])
Pain
Code List
Symptom Intensity on Day 1
CL Item
Behavior as usual (0)
CL Item
Symptom easily tolerated / no effect on normal activity (1)
CL Item
Symptom interferes with normal activity (2)
CL Item
Symptom prevents normal activity (3)
Item
Symptom Intensity on Day 2
integer
C0518690 (UMLS CUI [1])
Pain
Code List
Symptom Intensity on Day 2
CL Item
Behavior as usual (0)
CL Item
Symptom easily tolerated / no effect on normal activity (1)
CL Item
Symptom interferes with normal activity (2)
CL Item
Symptom prevents normal activity (3)
Item
Symptom Intensity on Day 3
integer
C0518690 (UMLS CUI [1])
Pain
Code List
Symptom Intensity on Day 3
CL Item
Behavior as usual (0)
CL Item
Symptom easily tolerated / no effect on normal activity (1)
CL Item
Symptom interferes with normal activity (2)
CL Item
Symptom prevents normal activity (3)
Number of episodes on Day 0
Item
Number of episodes on Day 0
integer
C0750480 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
Number of episodes on Day 1
Item
Number of episodes on Day 1
integer
C0750480 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
Number of episodes on Day 2
Item
Number of episodes on Day 2
integer
C0750480 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
Number of episodes on Day 3
Item
Number of episodes on Day 3
integer
C0750480 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
Symptom ongoing after Day 3?
Item
Symptom ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Last Day of Symptoms
Item
If Symptom is ongoing after Day 3, record date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Other General Symptoms
C0029625 (UMLS CUI-1)
General symptom description
Item
Description - please give details
text
C1457887 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Symptom Intensity
integer
C0518690 (UMLS CUI [1])
Symptom Intensity
Code List
Symptom Intensity
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
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)
Symptom start date
Item
Symptom start date
date
C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Symptom continuing?
Item
Symptom continuing?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Symptom end date
Item
Symptom end date
date
C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Medication
C2347852 (UMLS CUI-1)
Concomitant Medication name
Item
Trade/Generic name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medication Reason
Item
Concomitant Medication Reason
text
C0392360 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Concomitant Medication start date
Item
Start date
date
C2826734 (UMLS CUI [1])
Concomitant Medication End date
Item
End date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Ongoing?
Item
Medication continuing?
boolean
C2826666 (UMLS CUI [1])
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