ID

26124

Description

Study ID: 111029 Clinical Study ID: 111029 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A Documentation part: Additional Vaccination, Year 17, 0-12 months after visit 22

Link

https://clinicaltrials.gov/ct2/show/NCT00289757

Keywords

Versions (2)
  1. 10/9/17 10/9/17 -
  2. 10/9/17 10/9/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 9, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Additional Vaccination 111029

English

Additional Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029

1 forms  
Pre-vaccination assessment
Description

Pre-vaccination assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0042196
UMLS CUI-3
C0700881
UMLS CUI-4
C0170300
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route of temperature measurement
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0005903
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0700881
Has a blood sample been taken?
Description

Blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Has a blood sample been taken for CMI response determination?
Description

CMI response determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0020966
UMLS CUI [1,2]
C0005834
Has a urine sample been taken?
Description

urine sample

Data type

boolean

Alias
UMLS CUI [1]
C0200354
Result Urine Pregnancy test – HCG)
Description

Result Urine Pregnancy test

Data type

integer

Alias
UMLS CUI [1,1]
C0427777
UMLS CUI [1,2]
C0430056
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0700881
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Vaccine Administration
Description

Vaccine Administration

Data type

integer

Alias
UMLS CUI [1]
C2368628
Administration Side
Description

Non-dominant arm

Data type

text

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

Deltoid

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Route
Description

I.M.

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the Protocol ?
Description

Study vaccine Administration

Data type

boolean

Alias
UMLS CUI [1]
C2368628
Study vaccine Administration: Side
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Site
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Route
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Solicited Adverse Events - Local Symptoms
Description

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0700881
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
Description

symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2700396
Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness, size (mm)
Description

If Yes, please specify

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 0
Description

Redness on Day 0

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 1
Description

Redness on Day 1

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 2
Description

Redness on Day 2

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 3
Description

Redness on Day 3

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness ongoing after day 3?
Description

Redness ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Redness ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Swelling
Description

Swelling

Data type

boolean

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

If Yes, please specify

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 0
Description

Swelling on Day 0

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 1
Description

Swelling on Day 1

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 2
Description

Swelling on Day 2

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 3
Description

Swelling on Day 3

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling ongoing after day 3?
Description

Swelling ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Swelling ongoing after day 3? If Yes, please specify

Data type

date

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

Pain

Data type

boolean

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 0
Description

Pain on Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 1
Description

Pain on Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 2
Description

Pain on Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 3
Description

Pain on Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain ongoing after day 3?
Description

Pain ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Pain ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Solicited Adverse Events - General Symptoms
Description

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
UMLS CUI-4
C0700881
Fever
Description

Axillary > 37.5°C Oral > 37.5°C

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Fever
Description

If Yes, please specify

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever, Site of measurement
Description

Site of measurement

Data type

text

Alias
UMLS CUI [1,1]
C0449687
UMLS CUI [1,2]
C0015967
Fever on Day 0
Description

Fever on Day 0

Data type

integer

Alias
UMLS CUI [1]
C0015967
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
Fever on Day 1
Description

Fever on Day 1

Data type

integer

Alias
UMLS CUI [1]
C0015967
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
Fever on Day 2
Description

Fever on Day 2

Data type

integer

Alias
UMLS CUI [1]
C0015967
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
Fever on Day 3
Description

Fever on Day 3

Data type

integer

Alias
UMLS CUI [1]
C0015967
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
Fever ongoing after day 3?
Description

Fever ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Date of last day of symptoms
Description

Fever ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015967
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0015967
Fatigue
Description

Fatigue

Data type

boolean

Alias
UMLS CUI [1]
C0015672
Fatigue, Intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0522510
Fatigue on Day 0
Description

Fatigue on Day 0

Data type

integer

Alias
UMLS CUI [1]
C0015672
Fatigue on Day 1
Description

Fatigue on Day 1

Data type

integer

Alias
UMLS CUI [1]
C0015672
Fatigue on Day 2
Description

Fatigue on Day 2

Data type

integer

Alias
UMLS CUI [1]
C0015672
Fatigue on Day 3
Description

Fatigue on Day 3

Data type

integer

Alias
UMLS CUI [1]
C0015672
Fatigue ongoing after day 3?
Description

Fatigue ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1]
C0015672
Date of last day of symptoms
Description

Fatigue ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0011008
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0015672
Headache
Description

Headache

Data type

boolean

Alias
UMLS CUI [1]
C0018681
Headache, Intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0522510
Headache on Day 0
Description

Headache on Day 0

Data type

integer

Alias
UMLS CUI [1]
C0018681
Headache on Day 1
Description

Headache on Day 1

Data type

integer

Alias
UMLS CUI [1]
C0018681
Headache on Day 2
Description

Headache on Day 2

Data type

integer

Alias
UMLS CUI [1]
C0018681
Headache on Day 3
Description

Headache on Day 3

Data type

integer

Alias
UMLS CUI [1]
C0018681
Headache ongoing after day 3?
Description

Headache ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1]
C0018681
Date of last day of symptoms
Description

Headache ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0011008
Causality
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0018681
Gastrointestinal symptoms
Description

Gastrointestinal symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms, Intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0522510
Gastrointestinal symptoms on Day 0
Description

Gastrointestinal symptoms on Day 0

Data type

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms on Day 1
Description

Gastrointestinal symptoms on Day 1

Data type

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms on Day 2
Description

Gastrointestinal symptoms on Day 2

Data type

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms on Day 3
Description

Gastrointestinal symptoms on Day 3

Data type

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms ongoing after day 3?
Description

Gastrointestinal symptoms ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1]
C0426576
Date of last day of symptoms
Description

Gastrointestinal symptoms ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0011008
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0426576
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Similar models

Additional Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pre-vaccination assessment
C0220825 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
C0170300 (UMLS CUI-4)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route of temperature measurement
text
C0005903 (UMLS CUI [1])
Route of temperature measurement
Code List
Route of temperature measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
C0700881 (UMLS CUI-2)
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
CMI response determination
Item
Has a blood sample been taken for CMI response determination?
boolean
C0020966 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
urine sample
Item
Has a urine sample been taken?
boolean
C0200354 (UMLS CUI [1])
Item
Result Urine Pregnancy test – HCG)
integer
C0427777 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
Result from pregnancy test
Code List
Result Urine Pregnancy test – HCG)
CL Item
negative (1)
CL Item
positive (2)
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
C0700881 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
HAVRIX Vaccine  (1)
CL Item
Not administered (Please complete below) (2)
Administration Side
Item
Administration Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Site
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1])
Item
Study vaccine Administration: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Side
Code List
Study vaccine Administration: Side
CL Item
Non-dominant arm (1)
CL Item
Dominant arm (2)
Item
Study vaccine Administration: Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Site
Code List
Study vaccine Administration: Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Study vaccine Administration: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration Route
Code List
Study vaccine Administration: Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
symptoms
Item
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
boolean
C1457887 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
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])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
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])
Item Group
Solicited Adverse Events - General Symptoms
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0700881 (UMLS CUI-4)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever
float
C0015967 (UMLS CUI [1])
Item
Fever, Site of measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Site of measurement
Code List
Fever, Site of measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
rectal (R)
Item
Fever on Day 0
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 0
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 0
Item
Fever on Day 0
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 1
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 1
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 1
Item
Fever on Day 1
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 2
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 2
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 2
Item
Fever on Day 2
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 3
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 3
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 3
Item
Fever on Day 3
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever ongoing after day 3
Item
Fever ongoing after day 3?
boolean
C0015967 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue, Intensity
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Fatigue, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Fatigue on Day 0
integer
C0015672 (UMLS CUI [1])
Pain
Code List
Fatigue on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Fatigue on Day 1
integer
C0015672 (UMLS CUI [1])
Pain
Code List
Fatigue on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Fatigue on Day 2
integer
C0015672 (UMLS CUI [1])
Pain
Code List
Fatigue on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Fatigue on Day 3
integer
C0015672 (UMLS CUI [1])
Pain
Code List
Fatigue on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Fatigue ongoing after day 3
Item
Fatigue ongoing after day 3?
boolean
C0015672 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0015672 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015672 (UMLS CUI [2])
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Item
Headache, Intensity
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Headache, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Headache on Day 0
integer
C0018681 (UMLS CUI [1])
Pain
Code List
Headache on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Headache on Day 1
integer
C0018681 (UMLS CUI [1])
Pain
Code List
Headache on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Headache on Day 2
integer
C0018681 (UMLS CUI [1])
Pain
Code List
Headache on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Headache on Day 3
integer
C0018681 (UMLS CUI [1])
Pain
Code List
Headache on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Headache ongoing after day 3
Item
Headache ongoing after day 3?
boolean
C0018681 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality
boolean
C0015127 (UMLS CUI [1])
C0018681 (UMLS CUI [2])
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms, Intensity
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Gastrointestinal symptoms, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Gastrointestinal symptoms on Day 0
integer
C0426576 (UMLS CUI [1])
Pain
Code List
Gastrointestinal symptoms on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Gastrointestinal symptoms on Day 1
integer
C0426576 (UMLS CUI [1])
Pain
Code List
Gastrointestinal symptoms on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Gastrointestinal symptoms on Day 2
integer
C0426576 (UMLS CUI [1])
Pain
Code List
Gastrointestinal symptoms on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Gastrointestinal symptoms on Day 3
integer
C0426576 (UMLS CUI [1])
Pain
Code List
Gastrointestinal symptoms on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Gastrointestinal symptoms ongoing after day 3
Item
Gastrointestinal symptoms ongoing after day 3?
boolean
C0426576 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0426576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0426576 (UMLS CUI [2])
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