ID

38429

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 information on solicited adverse events (local and general symptoms ) in the first 3 days after the study vaccinations, as well as whether the subject has experienced unsolicited (serious) adverse events. Details of unsolicited adverse events are to be given in a different form. This form is to be filled in 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.

Keywords

  1. 9/2/19 9/2/19 -
  2. 10/17/19 10/17/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 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

Solicited and unsolicited adverse events

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
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Dose preceding assessment
Description

Dose 1 is at Visit 1. Dose 2 is at Visit 2. Dose 3 is at Visit 3. The Booster Dose of 10Pn-PD-DiT is at Visit 5 (not applicable to the HIV-neg. cohort, 3+0 schedule ). The Booster Dose of DTPw-HBV/Hib is at Visit 8. Please note that in the 2+1 schedule HIV-neg. cohort, the pneumococcal study vaccine is not administered at Visit 2. However, this Visit is still designated as "Dose 2", as the second dose of the DTPw-HBV/Hib vaccine is administered at this Visit.

Data type

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0220825
Solicited Adverse Events - Local Symptoms
Description

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
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
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

Redness, Swelling, Pain

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C1948053
Select symptom
Description

Fill in entire item group once per symptom

Data type

integer

Alias
UMLS CUI [1]
C1457887
Presence of Symptom
Description

If yes, give either Size on Days 0-3 for Redness and Swelling or Pain Intensity on Days 0-3 for Pain. In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0150312
Size Day 0
Description

for Redness and Swelling

Data type

integer

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

for Redness and Swelling

Data type

integer

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

for Redness and Swelling

Data type

integer

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

for Redness and Swelling

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
Solicited Adverse Events - General Symptoms
Description

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

Fever, Irritability/Fussiness, Drowsiness, Loss of appetite; Diarrhoea, Vomiting (those two are only applicable after Visit 2 and 3, and only if the Rotavirus Vaccine has been administered)

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1948053
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
Presence of Symptom
Description

If yes: For fever, selected route of measurement, answer whether fever has been measured on Days 0-3, and height of fever. For Irritability/Fussiness, Drowsiness and Loss of appetite, record symptom intensity on Days 0-3. For Vomiting and Diarrhoea (if appropriate), record number of vomiting/stool episodes per day on Days 0-3. Definition of fever: Axillary, Oral, Tympanic (oral conversion) >= 37.5 °C Rectal and Tympanic (rectal conversion) >= 38 °C

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0150312
Fever, Site of measurement
Description

Fever, Site of measurement

Data type

text

Alias
UMLS CUI [1,1]
C0449687
UMLS CUI [1,2]
C0015967
Temperature taken on Day 0?
Description

Temperature taken on Day 0?

Data type

boolean

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0884358
Fever on Day 0
Description

if taken, please specify

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Temperature taken on Day 1?
Description

Temperature taken on Day 1?

Data type

boolean

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0884358
Fever on Day 1
Description

if taken, please specify

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Temperature taken on Day 2?
Description

Temperature taken on Day 2?

Data type

boolean

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0884358
Fever on Day 2
Description

if taken, please specify

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Temperature taken on Day 3?
Description

Temperature taken on Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0884358
Fever on Day 3
Description

if taken, please specify

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
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 Diarrhoae and Vomiting, record number of 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 Diarrhoae and Vomiting, record number of 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 Diarrhoae and Vomiting, record number of 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 Diarrhoae and Vomiting, record number of 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
Symptom Causality
Description

NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event.

Data type

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1457887
Unsolicited Adverse Events
Description

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Description

within one month (minimum 30 days)

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0687676
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0042196
UMLS CUI [2,3]
C0687676

Similar models

Solicited and unsolicited adverse events

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])
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)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Dose preceding assessment
integer
C3174092 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Code List
Dose preceding assessment
CL Item
Dose 1 (1)
CL Item
Dose 2 (2)
CL Item
Dose 3 (3)
CL Item
Booster Dose of 10Pn-PD-DiT (4)
CL Item
Booster Dose of DTPw-HBV/Hib (5)
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Select vaccination
integer
C0042196 (UMLS CUI [1])
Code List
Select vaccination
CL Item
10Pn-PD-DiT Vaccine (1)
CL Item
DTPw-HBV/Hib Vaccine (2)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1948053 (UMLS CUI [1,4])
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available  (U)
CL Item
No Vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
Item
Select symptom
integer
C1457887 (UMLS CUI [1])
Code List
Select symptom
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Presence of Symptom
Item
Presence of Symptom
boolean
C1457887 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
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])
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])
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])
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])
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
Solicited Adverse Events - General Symptoms
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Item
Select symptom
integer
C1457887 (UMLS CUI [1])
Code List
Select symptom
CL Item
Fever (1)
CL Item
Irritability/Fussiness (2)
CL Item
Drowsiness (3)
CL Item
Loss of appetite (4)
CL Item
Diarrhoea (5)
CL Item
Vomiting (6)
Presence of Symptom
Item
Presence of Symptom
boolean
C1457887 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Item
Fever, Site of measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Code List
Fever, Site of 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)
Temperature taken on Day 0?
Item
Temperature taken on Day 0?
boolean
C0886414 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Fever on Day 0
Item
Fever on Day 0
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Temperature taken on Day 1?
Item
Temperature taken on Day 1?
boolean
C0886414 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Fever on Day 1
Item
Fever on Day 1
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Temperature taken on Day 2?
Item
Temperature taken on Day 2?
boolean
C0886414 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Fever on Day 2
Item
Fever on Day 2
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Temperature taken on Day 3?
Item
Temperature taken on Day 3?
boolean
C0886414 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Fever on Day 3
Item
Fever on Day 3
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Symptom Intensity on Day 0
integer
C0518690 (UMLS CUI [1])
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])
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])
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])
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])
Symptom Causality
Item
Symptom Causality
boolean
C0005903 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
C1519255 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available  (U)
CL Item
No Vaccine administered  (NA)
CL Item
No  (N)
CL Item
Yes, Fill in the Non-Serious Adverse Event form or Serious Adverse Event form as necessary (Y)

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