ID

26639

Description

A phase III, double-blinded, randomized, multicenter, clinical study to assess the safety and immunogenicity of GSK Biologicals' Tdap 0.3 mg candidate vaccine when given as a booster dose to healthy school children and adolescents (9-13 years of age), previously vaccinated with a 5th consecutive dose of acellular pertussis-containing vaccine, in studies APV-118 or APV-120 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00263679

Keywords

Versions (2)
  1. 10/17/17 10/17/17 -
  2. 10/23/17 10/23/17 -
Copyright Holder

glaxo smith kline

Uploaded on

October 23, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Study ID 100406/004 Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster, Visit 1

English

GSK Study ID 100406/004 Visit 1

1 forms  
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Protocol
Description

Protocol

Data type

integer

Alias
UMLS CUI [1]
C1507394
CRF
Description

Case Report File

Data type

text

Alias
UMLS CUI [1]
C1516308
Visit
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
I certify that Informed Consent has been obtained prior to any study procedure.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Informed Consent Date
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
Screening ID
Description

Screening identification number

Data type

integer

Alias
UMLS CUI [1]
C1300638
Study center
Description

Study center

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Previous Studies
Description

Previous Study

Data type

integer

Alias
UMLS CUI [1]
C2242969
Subject number
Description

Subject number of previous study

Data type

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Patient gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Other Race, please specify:
Description

Other Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility question
Description

Eligibility question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria? If No, please complete below
Description

Did the subject meet all the entry criteria?

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Subjects previously enrolled and vaccinated in GSK Bio’s studies APV-118 and APV-120 and who are 9 through 13 years of age
Description

Study subject participation status and Age

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0001779
Subjects for whom the investigator believes the requirements of the protocol will be complied with (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study.
Description

Medical history and physical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0031809
Subjects or subjects' parents/guardian have access to a telephone where they can be reached during the entire study period.
Description

Access to a telephone

Data type

boolean

Alias
UMLS CUI [1]
C1822200
Females of childbearing potential (i.e., who have reached menarche) at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and must be abstinent or have used adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant®, DepoProvera®, contraceptive skin patch or cervical ring) for one month prior to vaccination. Subjects also must agree to continue such precautions for two months after vaccination.
Description

Females of childbearing potential must have a negativ pregnancy test, must be abstinent or have used adequate contraceptive method

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [2,3]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
Description

concomitant therapy with Investigational agents

Data type

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1707479
UMLS CUI [2,2]
C1875384
Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study.
Description

Administration of a vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0042196
Administration of a tetanus-toxoid, diphtheria-toxoid or pertussis-antigen containing vaccine since the last study visit in GSK Bio studies APV-118 or APV-120.
Description

Concomitant therapy with vaccines

Data type

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0039620
UMLS CUI [2,1]
C1707479
UMLS CUI [2,2]
C0199806
UMLS CUI [3,1]
C1707479
UMLS CUI [3,2]
C0031237
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Description

Medical History of allergic disease or adverse event of vaccines

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C1116172
History of previous vaccination against hepatitis A or history of hepatitis A infection.
Description

History of previous vaccination against hepatitis A or history of hepatitis A infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0170300
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0019159
Hypersensitivity to any component of the vaccines.
Description

Hypersensitivity to any component of the vaccines

Data type

boolean

Alias
UMLS CUI [1]
C0571550
History of anaphylactic or anaphylactic-like reaction temporally associated with a previous dose of DTP vaccine.
Description

History of anaphylactic or anaphylactic-like reaction temporally associated with a previous dose of DTP vaccine.

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0002792
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C2220378
History of encephalopathy within seven days of administration of a previous dose of DTP vaccine, defined as an acute, severe central nervous system disorder unexplained by another cause, occurring within seven days following vaccination and which may be manifested by major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours with failure to recover within 24 hours. Even though causation by DTP vaccine cannot be established, no subsequent doses of pertussis vaccine should be given.
Description

History of encephalopathy adverse event within seven days of administration of a previous dose of DTP vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1116172
UMLS CUI [1,3]
C0085584
History of convulsions (seizures) with or without fever occurring within 3 days of receipt of a previous dose of DTP vaccine.
Description

Convulsions in due of a previous dose of DTP vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012559
UMLS CUI [1,3]
C0413534
UMLS CUI [1,4]
C0751494
Temperature of >40.5oC within 48 hours of receipt of a previous dose of DTP vaccine, not due to another identifiable cause
Description

Fever in due of a previous dose of DTP vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C1116172
UMLS CUI [1,2]
C0015967
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of receipt of a previous dose of DTP vaccine.
Description

Collapse or shock-like state in due of a previous dose of DTP vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C1116172
UMLS CUI [1,2]
C0036974
UMLS CUI [2,1]
C1116172
UMLS CUI [2,2]
C0549265
Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine.
Description

Persistent, severe, inconsolable screaming or crying in due of a previous dise of DTP vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C1116172
UMLS CUI [1,2]
C0012559
UMLS CUI [1,3]
C0521008
UMLS CUI [2,1]
C1116172
UMLS CUI [2,2]
C0012559
UMLS CUI [2,3]
C0010399
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy: defer immunization until neurologic status is clarified and stabilized.
Description

Progressive neurologic disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C1280477
Previously experienced transient thrombocytopenia or neurologic complications following an earlier immunization against either diphtheria and/or tetanus
Description

Thrombocytopenia or neurologic complications following an earlier immunization against either diphtheria and/or tetanus

Data type

boolean

Alias
UMLS CUI [1,1]
C1116172
UMLS CUI [1,2]
C0058773
UMLS CUI [1,3]
C0040034
UMLS CUI [2,1]
C1116172
UMLS CUI [2,2]
C0058773
UMLS CUI [2,3]
C0235029
Acute disease at the time of vaccination (Acute disease is defined as the presence of a moderate or severe illness with or without fever. Vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever, i.e., axillary temperature <37.5°C).
Description

Acute disease at the time of vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0521116
Pregnant or lactating female or female who is anticipating becoming pregnant within two months after vaccination.
Description

Pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Medical history
Description

Medical history

Alias
UMLS CUI-1
C0262926
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Description

Medical history

Data type

boolean

Alias
UMLS CUI [1]
C0262926
General medical history / physical examination
Description

General medical history / physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Diagnosis body systems
Description

Diagnosis body systems

Data type

integer

Alias
UMLS CUI [1,1]
C0682591
UMLS CUI [1,2]
C0011900
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Past or current diagnosis
Description

Past or current diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1444637
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0521116
Pre-vaccination assessment
Description

Pre-vaccination assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0042196
Length of the upper arm (non-dominant) to be injected:
Description

Please record the length of the upper arm (non-dominant). Clothing should be removed as to not interfere with the measurement. The upper arm length is defined as the distance between the acromion and the tip of the elbow.

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0426866
UMLS CUI [1,2]
C0446516
mm
Circumference of the mid upper arm (non-dominant) to be injected:
Description

The measurement will be performed at the mid-point of the upper arm (at mid distance between the acromion and the tip of the elbow), while the arm is held parallel to the trunk and the elbow is flexed in front at 90o (as if the subject were carrying a tray). Clothing (e.g., shirt, sweater, blouse) should be removed so as not to interfere with the measurements. The deltoid muscle should not be contracted during the measurement. The mid-point of the upper arm will be marked by study personnel at the time of r measurement and will be used as reference for further measurements done by the subject or subject's parents / guardian during the follow-up period. ĺ

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0562351
mm
Dominant arm?
Description

Dominat arm

Data type

integer

Alias
UMLS CUI [1]
C0023114
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
Blood sample
Description

Blood sample

Alias
UMLS CUI-1
C0005834
Has a blood sample been taken?
Description

Has a blood sample been taken?

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Description

Please complete only if different from visit date:

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Urine sample (Pregnancy test – HCG)
Description

Urine sample (Pregnancy test – HCG)

Alias
UMLS CUI-1
C0200354
Has a urine sample been taken?
Description

Has a urine sample been taken?

Data type

integer

Alias
UMLS CUI [1]
C0200354
Date urine sample taken
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
Pre-vaccination assessment
Description

Pre-vaccination assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0042196
Temperature
Description

Temperature

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1]
C0005903
degrees celsius
Route
Description

Temperature, measurement site

Data type

integer

Alias
UMLS CUI [1]
C0489453
Vaccine adminstration
Description

Vaccine adminstration

Alias
UMLS CUI-1
C2368628
Date of vaccine admninistration
Description

Please complete only if different from visit date:

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Vaccine administration
Description

(only one box must be ticked by vaccine)

Data type

integer

Alias
UMLS CUI [1]
C2368628
Side / site route
Description

Non-dominant, upper deltoid, i.M.

Data type

integer

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

Has the study vaccine been administered according to the Protocol?

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2599718
Arm:
Description

Handedness

Data type

integer

Alias
UMLS CUI [1]
C0023114
Site:
Description

Anatomic site

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
Route:
Description

Drug administration route

Data type

integer

Alias
UMLS CUI [1]
C0013153
Comments:
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Why not administered?
Description

Why not administered?

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C1548562
category for non administration:
Description

Category for non administration

Data type

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Please specify SAE N°
Description

Serious adverse event

Data type

integer

Alias
UMLS CUI [1]
C1519255
Please specify AE type
Description

Adverse event

Data type

integer

Alias
UMLS CUI [1]
C0877248
Please specify AE N° (Unsol.):
Description

Non-serious adverse event, unsolicited

Data type

integer

Alias
UMLS CUI [1]
C0877248
Please specify AE N° (Solicited)
Description

Non-serious adverse event, solicited

Data type

integer

Alias
UMLS CUI [1]
C0877248
Other, please specify:
Description

(e.g.: consent withdrawal, Protocol violation, …)

Data type

text

Alias
UMLS CUI [1]
C0877248
Who took the decision:
Description

Who took the decision

Data type

integer

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1548562
Adverse events - Post - vaccination oberservation
Description

Adverse events - Post - vaccination oberservation

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0700325
UMLS CUI-3
C0877248
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Description

Serious or non-serious unsolicited adverse events after vaccination

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0042196
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0042196
Measurement of mid upper arm circumference
Description

Measurement of mid upper arm circumference

Alias
UMLS CUI-1
C0562351
Measurement
Description

The measurement of mid upper arm circumference of the injected arm (administration side) should be taken everyday from Day 0 to Day 14.

Data type

integer

Alias
UMLS CUI [1]
C0242485
Circumference
Description

mid upper arm of injected arm (administration side) (mm)

Data type

integer

Alias
UMLS CUI [1]
C0562351
Measurement of mid upper arm circumference, continued
Description

Measurement of mid upper arm circumference, continued

Alias
UMLS CUI-1
C0562351
Ongoing after Day 14?
Description

If the circumference did not return to baseline + 10 mm on Day 14 please complete "Date of last Day of Symptoms"

Data type

boolean

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0562351
UMLS CUI [1,3]
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]
C1517741
UMLS CUI [1,3]
C1457887
Solicited adverse events - Local symptoms
Description

Solicited adverse events - Local 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

Note: The subject should return to the study site for evaluation if any of the following occur: swelling with diameter of >100 mm at the injection site. or a >50 mm increase of the mid-upper arm circumference when compared to the baseline (pre-vaccination) measurement, or a diffuse swelling of the arm to be injected that interferes with or prevents normal everyday activities (e.g., writing, use of computer, school attendance, sleeping, etc.) or diffuse swelling of the arm to be injected that involves the shoulder or chest If any of these adverse events are serious according to Protocol definition, please report event to GSK monitor by telephone or fax within 24 hours (see Protocol) and complete the Serious Adverse Event form.

Data type

integer

Alias
UMLS CUI [1]
C1457887
Local symptoms
Description

Local symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness size - Day 0
Description

Redness size - Day 0

Data type

integer

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

Redness size - Day 1

Data type

integer

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

Redness size - Day 2

Data type

integer

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

Redness size - Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 4
Description

Redness size - Day 4

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 5
Description

Redness size - Day 5

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 6
Description

Redness size - Day 6

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 7
Description

Redness size - Day 7

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 8
Description

Redness size - Day 8

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 9
Description

Redness size - Day 9

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 10
Description

Redness size - Day 10

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 11
Description

Redness size - Day 11

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 12
Description

Redness size - Day 12

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 13
Description

Redness size - Day 13

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size - Day 14
Description

Redness size - Day 14

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness - Ongoing after day 14?
Description

Redness - Ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Redness - Date of last day of symptom
Description

Redness - Date of last Day of Symptom

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Redness - Medical advice
Description

Redness - Medical advice

Data type

boolean

Alias
UMLS CUI [1,1]
C1386497
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Type - Medical advice
Description

Type - Medical advice

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
Swelling
Description

In case of large swelling reaction at the administration site, please fill in ALSO the swelling assessment report.

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling size - Day 0
Description

Swelling size - Day 0

Data type

integer

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

Swelling size - Day 1

Data type

integer

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

Swelling size - Day 2

Data type

integer

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

Swelling size - Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 4
Description

Swelling size - Day 4

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 5
Description

Swelling size - Day 5

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 6
Description

Swelling size - Day 6

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 7
Description

Swelling size - Day 7

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 8
Description

Swelling size - Day 8

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 9
Description

Swelling size - Day 9

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 10
Description

Swelling size - Day 10

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 11
Description

Swelling size - Day 11

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 12
Description

Swelling size - Day 12

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 13
Description

Swelling size - Day 13

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling size - Day 14
Description

Swelling size - Day 14

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling - Ongoing after day 14?
Description

Swelling - Ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Swelling - Date of last day of symptoms
Description

Swelling - 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
Swelling - Medical advice
Description

Swelling - Medical advice

Data type

boolean

Alias
UMLS CUI [1,1]
C1386497
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Type - Medical advice
Description

Type - Medical advice

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
Pain
Description

Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain intensity - Day 0
Description

Pain intensity - Day 0

Data type

integer

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

Pain intensity - Day 1

Data type

integer

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

Pain intensity - Day 2

Data type

integer

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

Pain intensity - Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 4
Description

Pain intensity - Day 4

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 5
Description

Pain intensity - Day 5

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 6
Description

Pain intensity - Day 6

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 7
Description

Pain intensity - Day 7

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 8
Description

Pain intensity - Day 8

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 9
Description

Pain intensity - Day 9

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 10
Description

Pain intensity - Day 10

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 11
Description

Pain intensity - Day 11

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 12
Description

Pain intensity - Day 12

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 13
Description

Pain intensity - Day 13

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain intensity - Day 14
Description

Pain intensity - Day 14

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain - Ongoing after day 14?
Description

Pain - Ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Pain - Date of the last day of symptoms
Description

Pain - Date of the last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Pain - Medical advice
Description

Pain - Medical advice

Data type

boolean

Alias
UMLS CUI [1,1]
C1386497
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Type - Medical advice
Description

Type - Medical advice

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
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 solicited signs/symptoms during the solicited period?
Description

If any of these adverse events are serious according to Protocol definition, please report event to GSK monitor by telephone or fax within 24 hours (see Protocol) and complete the Serious Adverse Event form.

Data type

integer

Alias
UMLS CUI [1]
C1457887
General Symptoms
Description

General Symptoms

Alias
UMLS CUI-1
C0159028
Fever
Description

Axillary > 37.5°C Oral > 37.5°C

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Body temperature - Measurement route
Description

If Fever yes, please choose measurement route

Data type

integer

Alias
UMLS CUI [1]
C0489453
Body temperature - Day 0
Description

Body temperature - Day 0

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C2826301
degrees celsius
Body temperature - Day 0 not taken
Description

Body temperature - Day 0 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C2826301
UMLS CUI [1,2]
C0437722
Body temperature - Day 1
Description

Body temperature - Day 1

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1442449
degrees celsius
Body temperature - Day 1 not taken
Description

Body temperature - Day 1 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C1442449
UMLS CUI [1,2]
C0437722
Body temperature - Day 2
Description

Body temperature - Day 2

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842676
degrees celsius
Body temperature - Day 2 not taken
Description

Body temperature - Day 2 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3842676
UMLS CUI [1,2]
C0437722
Body temperature - Day 3
Description

Body temperature - Day 3

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842675
degrees celsius
Body temperature - Day 3 not taken
Description

Body temperature - Day 3 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3842675
UMLS CUI [1,2]
C0437722
Body temperature - Day 4
Description

Body temperature - Day 4

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3840892
degrees celsius
Body temperature - Day 4 not taken
Description

Body temperature - Day 4 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3840892
UMLS CUI [1,2]
C0437722
Body temperature - Day 5
Description

Body temperature - Day 5

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842674
degrees celsius
Body temperature - Day 5 not taken
Description

Body temperature - Day 5 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3842674
UMLS CUI [1,2]
C0437722
Body temperature - Day 6
Description

Body temperature - Day 6

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842673
degrees celsius
Body temperature - Day 6 not taken
Description

Body temperature - Day 6 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3842673
UMLS CUI [1,2]
C0437722
Body temperature - Day 7
Description

Body temperature - Day 7

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842672
degrees celsius
Body temperature - Day 7 not taken
Description

Body temperature - Day 7 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3842672
UMLS CUI [1,2]
C0437722
Body temperature - Day 8
Description

Body temperature - Day 8

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0750480
degrees celsius
Body temperature - Day 8 not taken
Description

Body temperature - Day 8 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0437722
Body temperature - Day 9
Description

Body temperature - Day 9

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0750480
degrees celsius
Body temperature - Day 9 not taken
Description

Body temperature - Day 9 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0437722
Body temperature - Day 10
Description

Body temperature - Day 10

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0750480
degrees celsius
Body temperature - Day 10 not taken
Description

Body temperature - Day 10 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0437722
Body temperature - Day 11
Description

Body temperature - Day 11

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0750480
degrees celsius
Body temperature - Day 11 not taken
Description

Body temperature - Day 11 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0437722
Body temperature - Day 12
Description

Body temperature - Day 12

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0750480
degrees celsius
Body temperature - Day 12 not taken
Description

Body temperature - Day 12 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0437722
Body temperature - Day 13
Description

Body temperature - Day 13

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0750480
degrees celsius
Body temperature - Day 13 not taken
Description

Body temperature - Day 13 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0437722
Body temperature - Day 14
Description

Body temperature - Day 14

Data type

float

Measurement units
  • degrees celsius
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0750480
degrees celsius
Body temperature - Day 14 not taken
Description

Body temperature - Day 14 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0437722
Fever - Ongoing after day 14?
Description

Fever - Ongoing after day 14?

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C2826663
Fever - Date of last day of symptoms
Description

Fever - Date of last day of symptoms

Data type

date

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

Fever - Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
Fever - Medical advice
Description

Fever - Medical advice

Data type

boolean

Alias
UMLS CUI [1,1]
C1386497
UMLS CUI [1,2]
C0015967
Type - Medical advice
Description

Type - Medical advice

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
Fatigue
Description

Fatigue

Data type

boolean

Alias
UMLS CUI [1]
C0015672
Fatigue intensity - Day 0
Description

Fatigue intensity - Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C2826301
Fatigue intensity - Day 1
Description

Fatigue intensity - Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C1442449
Fatigue intensity - Day 2
Description

Fatigue intensity - Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842676
Fatigue intensity - Day 3
Description

Fatigue intensity - Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842675
Fatigue intensity - Day 4
Description

Fatigue intensity - Day 4

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3840892
Fatigue intensity - Day 5
Description

Fatigue intensity - Day 5

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842674
Fatigue intensity - Day 6
Description

Fatigue intensity - Day 6

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842673
Fatigue intensity - Day 7
Description

Fatigue intensity - Day 7

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842672
Fatigue intensity - Day 8
Description

Fatigue intensity - Day 8

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Fatigue intensity - Day 9
Description

Fatigue intensity - Day 9

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Fatigue intensity - Day 10
Description

Fatigue intensity - Day 10

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Fatigue intensity - Day 11
Description

Fatigue intensity - Day 11

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Fatigue intensity - Day 12
Description

Fatigue intensity - Day 12

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Fatigue intensity - Day 13
Description

Fatigue intensity - Day 13

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Fatigue - Ongoing after day 14?
Description

Fatigue - Ongoing after day 14?

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C2826663
Fatigue - Date of last day of symptoms
Description

Fatigue - Date of last day of symptoms

Data type

date

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

Fatigue - Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015672
Fatigue - Medical advice
Description

Fatigue - Medical advice

Data type

boolean

Alias
UMLS CUI [1,1]
C1386497
UMLS CUI [1,2]
C0015672
Type - Medical advice
Description

Type - Medical advice

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
Headache
Description

Headache

Data type

boolean

Alias
UMLS CUI [1]
C0018681
Headache intensity - Day 0
Description

Headache intensity - Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C2826301
Headache intensity - Day 1
Description

Headache intensity - Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C1442449
Headache intensity - Day 2
Description

Headache intensity - Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842676
Headache intensity - Day 3
Description

Headache intensity - Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842675
Headache intensity - Day 4
Description

Headache intensity - Day 4

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3840892
Headache intensity - Day 5
Description

Headache intensity - Day 5

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842674
Headache intensity - Day 6
Description

Headache intensity - Day 6

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842673
Headache intensity - Day 7
Description

Headache intensity - Day 7

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842672
Headache intensity - Day 8
Description

Headache intensity - Day 8

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Headache intensity - Day 9
Description

Headache intensity - Day 9

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Headache intensity - Day 10
Description

Headache intensity - Day 10

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Headache intensity - Day 11
Description

Headache intensity - Day 11

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Headache intensity - Day 12
Description

Headache intensity - Day 12

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Headache intensity - Day 13
Description

Headache intensity - Day 13

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Headache intensity - Day 14
Description

Headache intensity - Day 14

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Headache - Ongoing after day 14?
Description

Headache - Ongoing after day 14

Data type

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C2826663
Headache - Date of the last day of symptoms
Description

Headache - Date of the last day of symptoms

Data type

date

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

Headache - Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0018681
Headache - Medical advice
Description

Headache - Medical advice

Data type

boolean

Alias
UMLS CUI [1,1]
C1386497
UMLS CUI [1,2]
C0018681
Type - Medical advice
Description

Type - Medical advice

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
Gastrointestinal symptoms
Description

Gastrointestinal symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms intensity - Day 0
Description

Gastrointestinal symptoms intensity - Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C2826301
Gastrointestinal symptoms intensity - Day 1
Description

Gastrointestinal symptoms intensity - Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C1442449
Gastrointestinal symptoms intensity - Day 2
Description

Gastrointestinal symptoms intensity - Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842676
Gastrointestinal symptoms intensity - Day 3
Description

Gastrointestinal symptoms intensity - Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842676
Gastrointestinal symptoms intensity - Day 4
Description

Gastrointestinal symptoms intensity - Day 4

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3840892
Gastrointestinal symptoms intensity - Day 5
Description

Gastrointestinal symptoms intensity - Day 5

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842674
Gastrointestinal symptoms intensity - Day 6
Description

Gastrointestinal symptoms intensity - Day 6

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842673
Gastrointestinal symptoms intensity - Day 7
Description

Gastrointestinal symptoms intensity - Day 7

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842672
Gastrointestinal symptoms intensity - Day 8
Description

Gastrointestinal symptoms intensity - Day 8

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Gastrointestinal symptoms intensity - Day 9
Description

Gastrointestinal symptoms intensity - Day 9

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Gastrointestinal symptoms intensity - Day 10
Description

Gastrointestinal symptoms intensity - Day 10

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Gastrointestinal symptoms intensity - Day 11
Description

Gastrointestinal symptoms intensity - Day 11

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Gastrointestinal symptoms intensity - Day 12
Description

Gastrointestinal symptoms intensity - Day 12

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Gastrointestinal symptoms intensity - Day 13
Description

Gastrointestinal symptoms intensity - Day 13

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Gastrointestinal symptoms intensity - Day 14
Description

Gastrointestinal symptoms intensity - Day 14

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Gastrointestinal symptoms - Ongoing after day 14?
Description

Gastrointestinal symptoms - Ongoing after day 14

Data type

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C2826663
Gastrointestinal symptoms - Date of last day of symptoms
Description

Gastrointestinal symptoms - Date of last day of symptoms

Data type

date

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

Gastrointestinal symptoms - Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0426576
Gastrointestinal symptoms - Medical advice
Description

Gastrointestinal symptoms - Medical advice

Data type

boolean

Alias
UMLS CUI [1,1]
C1386497
UMLS CUI [1,2]
C0426576
Type - Medical Advice
Description

Type - Medical Advice

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
Contact person
Description

Contact person

Alias
UMLS CUI-1
C0337611
Have the subject's parent(s) / guardian(s) been contacted by telephone?
Description

Please contact the subject's parent(s) / guardian(s) by phone 3 - 5 days after administration of the study vaccine dose to ensure completion of the diary card, to follow up on the occurrence of solicited local and solicited general adverse events, unsolicited adverse events, administration of medication, and to check on the occurrence of SAEs.

Data type

boolean

Alias
UMLS CUI [1]
C0420309
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Similar models

GSK Study ID 100406/004 Visit 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Protocol
Item
Protocol
integer
C1507394 (UMLS CUI [1])
Case Report File
Item
CRF
text
C1516308 (UMLS CUI [1])
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Informed Consent
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Screening identification number
Item
Screening ID
integer
C1300638 (UMLS CUI [1])
Study center
Item
Study center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Previous Studies
integer
C2242969 (UMLS CUI [1])
Previous Study
Code List
Previous Studies
CL Item
208355/118 (APV-118) (1)
CL Item
208355/120 (APV-120) (2)
Subject number of previous study
Item
Subject number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Patient gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
[1] Black (1)
CL Item
[4] Arabic/North African (2)
CL Item
[2] White/Caucasian (3)
CL Item
[5] East & South East Asian (4)
CL Item
[6] South Asian (5)
CL Item
[9] Other (6)
Other Race
Item
Other Race, please specify:
text
C0034510 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item Group
Eligibility question
C0013893 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria? If No, please complete below
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Study subject participation status and Age
Item
Subjects previously enrolled and vaccinated in GSK Bio’s studies APV-118 and APV-120 and who are 9 through 13 years of age
boolean
C2348568 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Compliance behavior
Item
Subjects for whom the investigator believes the requirements of the protocol will be complied with (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study
boolean
C1321605 (UMLS CUI [1])
Informed consent
Item
Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Medical history and physical examination
Item
Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study.
boolean
C0262926 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Access to a telephone
Item
Subjects or subjects' parents/guardian have access to a telephone where they can be reached during the entire study period.
boolean
C1822200 (UMLS CUI [1])
Females of childbearing potential must have a negativ pregnancy test, must be abstinent or have used adequate contraceptive method
Item
Females of childbearing potential (i.e., who have reached menarche) at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and must be abstinent or have used adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant®, DepoProvera®, contraceptive skin patch or cervical ring) for one month prior to vaccination. Subjects also must agree to continue such precautions for two months after vaccination.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0036899 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
concomitant therapy with Investigational agents
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
boolean
C1707479 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1707479 (UMLS CUI [2,1])
C1875384 (UMLS CUI [2,2])
Administration of a vaccine
Item
Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study.
boolean
C1707479 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Concomitant therapy with vaccines
Item
Administration of a tetanus-toxoid, diphtheria-toxoid or pertussis-antigen containing vaccine since the last study visit in GSK Bio studies APV-118 or APV-120.
boolean
C1707479 (UMLS CUI [1,1])
C0039620 (UMLS CUI [1,2])
C1707479 (UMLS CUI [2,1])
C0199806 (UMLS CUI [2,2])
C1707479 (UMLS CUI [3,1])
C0031237 (UMLS CUI [3,2])
Medical History of allergic disease or adverse event of vaccines
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C1116172 (UMLS CUI [2,2])
History of previous vaccination against hepatitis A or history of hepatitis A infection
Item
History of previous vaccination against hepatitis A or history of hepatitis A infection.
boolean
C0262926 (UMLS CUI [1,1])
C0170300 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0019159 (UMLS CUI [2,2])
Hypersensitivity to any component of the vaccines
Item
Hypersensitivity to any component of the vaccines.
boolean
C0571550 (UMLS CUI [1])
History of anaphylactic or anaphylactic-like reaction temporally associated with a previous dose of DTP vaccine.
Item
History of anaphylactic or anaphylactic-like reaction temporally associated with a previous dose of DTP vaccine.
boolean
C0262926 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C2220378 (UMLS CUI [2,2])
History of encephalopathy adverse event within seven days of administration of a previous dose of DTP vaccine
Item
History of encephalopathy within seven days of administration of a previous dose of DTP vaccine, defined as an acute, severe central nervous system disorder unexplained by another cause, occurring within seven days following vaccination and which may be manifested by major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours with failure to recover within 24 hours. Even though causation by DTP vaccine cannot be established, no subsequent doses of pertussis vaccine should be given.
boolean
C0262926 (UMLS CUI [1,1])
C1116172 (UMLS CUI [1,2])
C0085584 (UMLS CUI [1,3])
Convulsions in due of a previous dose of DTP vaccine
Item
History of convulsions (seizures) with or without fever occurring within 3 days of receipt of a previous dose of DTP vaccine.
boolean
C0262926 (UMLS CUI [1,1])
C0012559 (UMLS CUI [1,2])
C0413534 (UMLS CUI [1,3])
C0751494 (UMLS CUI [1,4])
Fever in due of a previous dose of DTP vaccine
Item
Temperature of >40.5oC within 48 hours of receipt of a previous dose of DTP vaccine, not due to another identifiable cause
boolean
C1116172 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Collapse or shock-like state in due of a previous dose of DTP vaccine
Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of receipt of a previous dose of DTP vaccine.
boolean
C1116172 (UMLS CUI [1,1])
C0036974 (UMLS CUI [1,2])
C1116172 (UMLS CUI [2,1])
C0549265 (UMLS CUI [2,2])
Persistent, severe, inconsolable screaming or crying in due of a previous dise of DTP vaccine
Item
Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine.
boolean
C1116172 (UMLS CUI [1,1])
C0012559 (UMLS CUI [1,2])
C0521008 (UMLS CUI [1,3])
C1116172 (UMLS CUI [2,1])
C0012559 (UMLS CUI [2,2])
C0010399 (UMLS CUI [2,3])
Progressive neurologic disorder
Item
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy: defer immunization until neurologic status is clarified and stabilized.
boolean
C0027765 (UMLS CUI [1,1])
C1280477 (UMLS CUI [1,2])
Thrombocytopenia or neurologic complications following an earlier immunization against either diphtheria and/or tetanus
Item
Previously experienced transient thrombocytopenia or neurologic complications following an earlier immunization against either diphtheria and/or tetanus
boolean
C1116172 (UMLS CUI [1,1])
C0058773 (UMLS CUI [1,2])
C0040034 (UMLS CUI [1,3])
C1116172 (UMLS CUI [2,1])
C0058773 (UMLS CUI [2,2])
C0235029 (UMLS CUI [2,3])
Acute disease at the time of vaccination
Item
Acute disease at the time of vaccination (Acute disease is defined as the presence of a moderate or severe illness with or without fever. Vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever, i.e., axillary temperature <37.5°C).
boolean
C0001314 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Pregnant or lactating
Item
Pregnant or lactating female or female who is anticipating becoming pregnant within two months after vaccination.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Item Group
Medical history
C0262926 (UMLS CUI-1)
Medical history
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0262926 (UMLS CUI [1])
Item Group
General medical history / physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
Diagnosis body systems
integer
C0682591 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Diagnosis body systems
Code List
Diagnosis body systems
CL Item
Cutaneous (1)
CL Item
Eyes (2)
CL Item
Ears-nose-throat (3)
CL Item
Cardiovascular (4)
CL Item
Respiratory (5)
CL Item
Gastrointestinal (6)
CL Item
Muskuloskeletal (7)
CL Item
Neurological (8)
CL Item
Genitourinary (9)
CL Item
Haematology (10)
CL Item
Allergies (11)
CL Item
Endocrine (12)
CL Item
Other (specify) (13)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Past or current diagnosis
integer
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
Past or current
Code List
Past or current diagnosis
CL Item
past (1)
CL Item
current (2)
Item Group
Pre-vaccination assessment
C0220825 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Baseline measurement of the length of upper arm to be injected
Item
Length of the upper arm (non-dominant) to be injected:
integer
C0426866 (UMLS CUI [1,1])
C0446516 (UMLS CUI [1,2])
Baseline measurement of mid upper arm circumference
Item
Circumference of the mid upper arm (non-dominant) to be injected:
integer
C0562351 (UMLS CUI [1])
Item
Dominant arm?
integer
C0023114 (UMLS CUI [1])
Dominat arm
Code List
Dominant arm?
CL Item
Left (1)
CL Item
Right (2)
CL Item
Ambidextrous (3)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Item Group
Blood sample
C0005834 (UMLS CUI-1)
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date blood sample taken
Item
Date blood sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Urine sample (Pregnancy test – HCG)
C0200354 (UMLS CUI-1)
Item
Has a urine sample been taken?
integer
C0200354 (UMLS CUI [1])
Has a urine sample been taken?
Code List
Has a urine sample been taken?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (not of childbearing potential or male) (3)
Date urine sample taken
Item
Date urine sample taken
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Pre-vaccination assessment
C0220825 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
integer
C0489453 (UMLS CUI [1])
Route
Code List
Route
CL Item
Axillary (preferred) (1)
CL Item
Oral (2)
Item Group
Vaccine adminstration
C2368628 (UMLS CUI-1)
Date of vaccine admninistration
Item
Date of vaccine admninistration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
dTpa 0.3mg Vaccine or Havrix® Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Item
Side / site route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Side / site route
Code List
Side / site route
CL Item
Left (1)
CL Item
Right (2)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2599718 (UMLS CUI [1,2])
Item
Arm:
integer
C0023114 (UMLS CUI [1])
Arm
Code List
Arm:
CL Item
Dominant (1)
CL Item
Non dominant (2)
CL Item
NA (3)
Item
Site:
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Site
Code List
Site:
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route:
integer
C0013153 (UMLS CUI [1])
Drug administration route
Code List
Route:
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
Why not administered?
C0042210 (UMLS CUI-1)
C1548562 (UMLS CUI-2)
Item
category for non administration:
integer
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Non administration
Code List
category for non administration:
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event page) (2)
CL Item
Other (3)
Serious adverse event
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1])
Item
Please specify AE type
integer
C0877248 (UMLS CUI [1])
Non-serious Adverse Event
Code List
Please specify AE type
CL Item
Unsolicited (1)
CL Item
Solicited (2)
Non-serious adverse event, unsolicited
Item
Please specify AE N° (Unsol.):
integer
C0877248 (UMLS CUI [1])
Non-serious adverse event, solicited
Item
Please specify AE N° (Solicited)
integer
C0877248 (UMLS CUI [1])
Other adverse event
Item
Other, please specify:
text
C0877248 (UMLS CUI [1])
Item
Who took the decision:
integer
C0679006 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1548562 (UMLS CUI [1,3])
Who took the decision
Code List
Who took the decision:
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Adverse events - Post - vaccination oberservation
C0042196 (UMLS CUI-1)
C0700325 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
integer
C1519255 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
Serious or non-serious unsolicited adverse events
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 retrievable (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the non-serious adverse event pages or serious adverse event form. (4)
Item Group
Measurement of mid upper arm circumference
C0562351 (UMLS CUI-1)
Item
Measurement
integer
C0242485 (UMLS CUI [1])
Measurement
Code List
Measurement
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)
CL Item
Day 7 (8)
CL Item
Day 8 (9)
CL Item
Day 9 (10)
CL Item
Day 10 (11)
CL Item
Day 11 (12)
CL Item
Day 12 (13)
CL Item
Day 13 (14)
CL Item
Day 14 (15)
Mid upper arm circumference
Item
Circumference
integer
C0562351 (UMLS CUI [1])
Item Group
Measurement of mid upper arm circumference, continued
C0562351 (UMLS CUI-1)
Measurement of mid upper arm circumference continued
Item
Ongoing after Day 14?
boolean
C0242485 (UMLS CUI [1,1])
C0562351 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Date of last Day of Symptoms
Item
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 - Local 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?
integer
C1457887 (UMLS CUI [1])
Occurrence of symptoms during the solicited period
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not retrievable (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Item Group
Local symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness size - Day 0
Item
Redness size - Day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 1
Item
Redness size - Day 1
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 2
Item
Redness size - Day 2
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 3
Item
Redness size - Day 3
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 4
Item
Redness size - Day 4
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 5
Item
Redness size - Day 5
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 6
Item
Redness size - Day 6
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 7
Item
Redness size - Day 7
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 8
Item
Redness size - Day 8
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 9
Item
Redness size - Day 9
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 10
Item
Redness size - Day 10
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 11
Item
Redness size - Day 11
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 12
Item
Redness size - Day 12
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 13
Item
Redness size - Day 13
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size - Day 14
Item
Redness size - Day 14
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness - Ongoing
Item
Redness - Ongoing after day 14?
boolean
C0332575 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness - Date of last Day of Symptom
Item
Redness - Date of last day of symptom
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness - Medical advice
Item
Redness - Medical advice
boolean
C1386497 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Type - Medical advice
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical advice
Code List
Type - Medical advice
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling size - Day 0
Item
Swelling size - Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 1
Item
Swelling size - Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 2
Item
Swelling size - Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 3
Item
Swelling size - Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 4
Item
Swelling size - Day 4
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 5
Item
Swelling size - Day 5
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 6
Item
Swelling size - Day 6
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 7
Item
Swelling size - Day 7
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 8
Item
Swelling size - Day 8
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 9
Item
Swelling size - Day 9
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 10
Item
Swelling size - Day 10
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 11
Item
Swelling size - Day 11
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 12
Item
Swelling size - Day 12
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 13
Item
Swelling size - Day 13
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling size - Day 14
Item
Swelling size - Day 14
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling - Ongoing
Item
Swelling - Ongoing after day 14?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling - Date of last day of symptoms
Item
Swelling - Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling - Medical advice
Item
Swelling - Medical advice
boolean
C1386497 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Type - Medical advice
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical advice
Code List
Type - Medical advice
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain intensity - Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 4
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 4
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 5
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 5
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 6
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 6
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 7
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 7
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 8
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 8
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 9
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 9
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 10
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 10
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 11
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 11
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 12
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 12
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 13
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 13
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity - Day 14
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity - Day 0
Code List
Pain intensity - Day 14
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Pain - Ongoing
Item
Pain - Ongoing after day 14?
boolean
C0030193 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain - Date of the last day of symptoms
Item
Pain - Date of the last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain - Medical advice
Item
Pain - Medical advice
boolean
C1386497 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Type - Medical advice
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical advice
Code List
Type - Medical advice
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (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 solicited signs/symptoms during the solicited period?
integer
C1457887 (UMLS CUI [1])
Occurrence of symptoms during the solicited period
Code List
Has the subject experienced any of the following solicited signs/symptoms during the solicited period?
CL Item
Information not retrievable (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Body temperature - Measurement route
integer
C0489453 (UMLS CUI [1])
Fever - Measurement route
Code List
Body temperature - Measurement route
CL Item
Axillary (preferred) (1)
CL Item
Oral (2)
Body temperature - Day 0
Item
Body temperature - Day 0
float
C0005903 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Body temperature - Day 0 not taken
Item
Body temperature - Day 0 not taken
boolean
C2826301 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature - Day 1
Item
Body temperature - Day 1
float
C0005903 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Body temperature - Day 1 not taken
Item
Body temperature - Day 1 not taken
boolean
C1442449 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature - Day 2
Item
Body temperature - Day 2
float
C0005903 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Body temperature - Day 2 not taken
Item
Body temperature - Day 2 not taken
boolean
C3842676 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature - Day 3
Item
Body temperature - Day 3
float
C0005903 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Body temperature - Day 3 not taken
Item
Body temperature - Day 3 not taken
boolean
C3842675 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature - Day 4
Item
Body temperature - Day 4
float
C0005903 (UMLS CUI [1,1])
C3840892 (UMLS CUI [1,2])
Body temperature - Day 4 not taken
Item
Body temperature - Day 4 not taken
boolean
C3840892 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature - Day 5
Item
Body temperature - Day 5
float
C0005903 (UMLS CUI [1,1])
C3842674 (UMLS CUI [1,2])
Body temperature - Day 5 not taken
Item
Body temperature - Day 5 not taken
boolean
C3842674 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature - Day 6
Item
Body temperature - Day 6
float
C0005903 (UMLS CUI [1,1])
C3842673 (UMLS CUI [1,2])
Body temperature - Day 6 not taken
Item
Body temperature - Day 6 not taken
boolean
C3842673 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature - Day 7
Item
Body temperature - Day 7
float
C0005903 (UMLS CUI [1,1])
C3842672 (UMLS CUI [1,2])
Body temperature - Day 7 not taken
Item
Body temperature - Day 7 not taken
boolean
C3842672 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature - Day 8
Item
Body temperature - Day 8
float
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Body temperature - Day 8 not taken
Item
Body temperature - Day 8 not taken
boolean
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,3])
Body temperature - Day 9
Item
Body temperature - Day 9
float
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Body temperature - Day 9 not taken
Item
Body temperature - Day 9 not taken
boolean
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,3])
Body temperature - Day 10
Item
Body temperature - Day 10
float
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Body temperature - Day 10 not taken
Item
Body temperature - Day 10 not taken
boolean
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,3])
Body temperature - Day 11
Item
Body temperature - Day 11
float
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Body temperature - Day 11 not taken
Item
Body temperature - Day 11 not taken
boolean
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,3])
Body temperature - Day 12
Item
Body temperature - Day 12
float
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Body temperature - Day 12 not taken
Item
Body temperature - Day 12 not taken
boolean
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,3])
Body temperature - Day 13
Item
Body temperature - Day 13
float
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Body temperature - Day 13 not taken
Item
Body temperature - Day 13 not taken
boolean
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,3])
Body temperature - Day 14
Item
Body temperature - Day 14
float
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Body temperature - Day 14 not taken
Item
Body temperature - Day 14 not taken
boolean
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,3])
Fever - Ongoing after day 14?
Item
Fever - Ongoing after day 14?
boolean
C0015967 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Fever - Date of last day of symptoms
Item
Fever - Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever - Causality
Item
Fever - Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever - Medical advice
Item
Fever - Medical advice
boolean
C1386497 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Type - Medical advice
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical advice
Code List
Type - Medical advice
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue intensity - Day 0
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 1
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 2
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 3
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 4
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3840892 (UMLS CUI [1,3])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 4
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 5
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842674 (UMLS CUI [1,3])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 5
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 6
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842673 (UMLS CUI [1,3])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 6
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 7
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842672 (UMLS CUI [1,3])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 7
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 8
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 8
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 9
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 9
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 10
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 10
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 11
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 11
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 12
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 12
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue intensity - Day 13
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Fatique intensity - Day 0
Code List
Fatigue intensity - Day 13
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Fatigue - Ongoing after day 14?
Item
Fatigue - Ongoing after day 14?
boolean
C0015672 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Fatigue - Date of last day of symptoms
Item
Fatigue - Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Fatigue - Causality
Item
Fatigue - Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Fatigue - Medical advice
Item
Fatigue - Medical advice
boolean
C1386497 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Item
Type - Medical advice
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical advice
Code List
Type - Medical advice
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Item
Headache intensity - Day 0
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Headache intensity - Day 0
Code List
Headache intensity - Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 1
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Headache intensity - Day 0
Code List
Headache intensity - Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 2
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Headache intensity - Day 0
Code List
Headache intensity - Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 3
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
Headache intensity - Day 0
Code List
Headache intensity - Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 4
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3840892 (UMLS CUI [1,3])
Headache intensity - Day 0
Code List
Headache intensity - Day 4
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 5
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842674 (UMLS CUI [1,3])
Headache intensity - Day 0
Code List
Headache intensity - Day 5
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 6
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842673 (UMLS CUI [1,3])
Headache intensity - Day 0
Code List
Headache intensity - Day 6
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 7
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842672 (UMLS CUI [1,3])
Headache intensity - Day 0
Code List
Headache intensity - Day 7
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 8
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Headache intensity - Day 0
Code List
Headache intensity - Day 8
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 9
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Headache intensity - Day 0
Code List
Headache intensity - Day 9
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 10
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Headache intensity - Day 0
Code List
Headache intensity - Day 10
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 11
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Headache intensity - Day 0
Code List
Headache intensity - Day 11
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 12
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Headache intensity - Day 0
Code List
Headache intensity - Day 12
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 13
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Headache intensity - Day 0
Code List
Headache intensity - Day 13
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache intensity - Day 14
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Headache intensity - Day 0
Code List
Headache intensity - Day 14
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Headache - Ongoing after day 14
Item
Headache - Ongoing after day 14?
boolean
C0018681 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Headache - Date of the last day of symptoms
Item
Headache - Date of the last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
Headache - Causality
Item
Headache - Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
Headache - Medical advice
Item
Headache - Medical advice
boolean
C1386497 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
Item
Type - Medical advice
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical advice
Code List
Type - Medical advice
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms intensity - Day 0
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Gastrointestinal symptoms intensity - Day 0
Code List
Gastrointestinal symptoms intensity - Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 1
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Gastrointestinal symptoms intensity - Day 01
Code List
Gastrointestinal symptoms intensity - Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 2
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Gastrointestinal symptoms intensity - Day 2
Code List
Gastrointestinal symptoms intensity - Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 3
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Gastrointestinal symptoms intensity - Day 3
Code List
Gastrointestinal symptoms intensity - Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 4
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3840892 (UMLS CUI [1,3])
Gastrointestinal symptoms intensity - Day 04
Code List
Gastrointestinal symptoms intensity - Day 4
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 5
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842674 (UMLS CUI [1,3])
Gastrointestinal symptoms intensity - Day 05
Code List
Gastrointestinal symptoms intensity - Day 5
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 6
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842673 (UMLS CUI [1,3])
Gastrointestinal symptoms intensity - Day 6
Code List
Gastrointestinal symptoms intensity - Day 6
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 7
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842672 (UMLS CUI [1,3])
Gastrointestinal symptoms intensity - Day 7
Code List
Gastrointestinal symptoms intensity - Day 7
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 8
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Gastrointestinal symptoms intensity - Day 8
Code List
Gastrointestinal symptoms intensity - Day 8
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 9
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Gastrointestinal symptoms intensity - Day 9
Code List
Gastrointestinal symptoms intensity - Day 9
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 10
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Gastrointestinal symptoms intensity - Day 10
Code List
Gastrointestinal symptoms intensity - Day 10
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 11
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Gastrointestinal symptoms intensity - Day 11
Code List
Gastrointestinal symptoms intensity - Day 11
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 12
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Gastrointestinal symptoms intensity - Day 13
Code List
Gastrointestinal symptoms intensity - Day 12
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 13
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Gastrointestinal symptoms intensity - Day 13
Code List
Gastrointestinal symptoms intensity - Day 13
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms intensity - Day 14
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Gastrointestinal symptoms intensity - Day 14
Code List
Gastrointestinal symptoms intensity - Day 14
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Gastrointestinal symptoms - Ongoing after day 14
Item
Gastrointestinal symptoms - Ongoing after day 14?
boolean
C0426576 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Gastrointestinal symptoms - Date of last day of symptoms
Item
Gastrointestinal symptoms - Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0426576 (UMLS CUI [1,2])
Gastrointestinal symptoms - Causality
Item
Gastrointestinal symptoms - Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0426576 (UMLS CUI [1,2])
Gastrointestinal symptoms - Medical advice
Item
Gastrointestinal symptoms - Medical advice
boolean
C1386497 (UMLS CUI [1,1])
C0426576 (UMLS CUI [1,2])
Item
Type - Medical Advice
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical Advice
Code List
Type - Medical Advice
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Item Group
Contact person
C0337611 (UMLS CUI-1)
Telephone contact 1
Item
Have the subject's parent(s) / guardian(s) been contacted by telephone?
boolean
C0420309 (UMLS CUI [1])
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