ID

26439

Beschreibung

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

Stichworte

Versionen (2)
  1. 17.10.17 17.10.17 -
  2. 23.10.17 23.10.17 -
Rechteinhaber

glaxo smith kline

Hochgeladen am

17. Oktober 2017

DOI

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Lizenz

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

Englisch

GSK Study ID 100406/004 Visit 1

1 Formulare  
Informed Consent
Beschreibung

Informed Consent

Alias
UMLS CUI-1
C0021430
Protocol
Beschreibung

Protocol

Datentyp

integer

Alias
UMLS CUI [1]
C1507394
CRF
Beschreibung

Case Report File

Datentyp

text

Alias
UMLS CUI [1]
C1516308
Visit
Beschreibung

Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschreibung

Subject number

Datentyp

integer

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Informed Consent Date
Beschreibung

Informed Consent Date

Datentyp

date

Alias
UMLS CUI [1]
C2985782
Screening ID
Beschreibung

Screening identification number

Datentyp

integer

Alias
UMLS CUI [1]
C1300638
Study center
Beschreibung

Study center

Datentyp

text

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

Previous Study

Datentyp

integer

Alias
UMLS CUI [1]
C2242969
Subject number
Beschreibung

Subject number of previous study

Datentyp

integer

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

Demographics

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Patient gender

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

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

Other Race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility question
Beschreibung

Eligibility question

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

Did the subject meet all the entry criteria?

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Beschreibung

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
Beschreibung

Study subject participation status and Age

Datentyp

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
Beschreibung

Compliance behavior

Datentyp

boolean

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

Informed consent

Datentyp

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.
Beschreibung

Medical history and physical examination

Datentyp

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.
Beschreibung

Access to a telephone

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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.
Beschreibung

concomitant therapy with Investigational agents

Datentyp

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.
Beschreibung

Administration of a vaccine

Datentyp

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.
Beschreibung

Concomitant therapy with vaccines

Datentyp

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.
Beschreibung

Medical History of allergic disease or adverse event of vaccines

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Hypersensitivity to any component of the vaccines

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Convulsions in due of a previous dose of DTP vaccine

Datentyp

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
Beschreibung

Fever in due of a previous dose of DTP vaccine

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Progressive neurologic disorder

Datentyp

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
Beschreibung

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

Datentyp

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).
Beschreibung

Acute disease at the time of vaccination

Datentyp

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.
Beschreibung

Pregnant or lactating

Datentyp

boolean

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

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?
Beschreibung

Medical history

Datentyp

boolean

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

General medical history / physical examination

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

Diagnosis body systems

Datentyp

integer

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

Diagnosis

Datentyp

text

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

Past or current diagnosis

Datentyp

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
Beschreibung

Pre-vaccination assessment

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

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.

Datentyp

integer

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

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

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1]
C0562351
mm
Dominant arm?
Beschreibung

Dominat arm

Datentyp

integer

Alias
UMLS CUI [1]
C0023114
Laboratory tests
Beschreibung

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Beschreibung

Blood sample taken?

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Please complete only if different from visit date
Beschreibung

Blood sample date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
Has a urine sample been taken?
Beschreibung

Urine sample taken

Datentyp

integer

Alias
UMLS CUI [1]
C0200354
Please complete only if different from visit date:
Beschreibung

Urin sample date

Datentyp

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
Result
Beschreibung

Urin sample results

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Route
Beschreibung

Drug Administration Routes

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
Vaccine adminstration
Beschreibung

Vaccine adminstration

Alias
UMLS CUI-1
C2368628
Please complete only if different from visit date:
Beschreibung

Vaccine administration date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Vaccine administration
Beschreibung

(only one box must be ticked by vaccine)

Datentyp

integer

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

Non-dominant, upper deltoid, i.M.

Datentyp

integer

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

Study vaccine been administered according to the Protocol

Datentyp

boolean

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

Handedness

Datentyp

integer

Alias
UMLS CUI [1]
C0023114
Site:
Beschreibung

Site

Datentyp

integer

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

Drug administration route

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
Comments:
Beschreibung

Comments

Datentyp

text

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

Why not administered?

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

Non administration

Datentyp

integer

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

Serious adverse event

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Please specify AE N°
Beschreibung

Non-serious adverse event

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Please specify AE N° (Unsol.):
Beschreibung

Non-serious adverse event, unsolicited

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Please specify AE N° (Solicited)
Beschreibung

Non-serious adverse event, solicited

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Other, please specify:
Beschreibung

Other events

Datentyp

text

Alias
UMLS CUI [1]
C0441471
Who took the decision:
Beschreibung

Who took the decision

Datentyp

integer

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

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?
Beschreibung

Serious or non-serious unsolicited adverse events

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0042196
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0042196
Measurement of mid upper arm circumference
Beschreibung

Measurement of mid upper arm circumference

Alias
UMLS CUI-1
C0562351
Measurement
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C0242485
Circumference
Beschreibung

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

Datentyp

integer

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

Measurement of mid upper arm circumference, continued

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

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0562351
UMLS CUI [1,3]
C0549178
Date of last Day of Symptoms
Beschreibung

Date of last Day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Solicited adverse events - Local symptoms
Beschreibung

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?
Beschreibung

Occurrence of symptoms during the solicited period

Datentyp

integer

Alias
UMLS CUI [1]
C1457887
Local symptoms
Beschreibung

Local symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Local symptoms
Beschreibung

Should be taken everyday from Day 0 to Day 14.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Redness ( RE )
Beschreibung

Redness

Datentyp

boolean

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

Redness size (mm)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
Swelling ( SW )
Beschreibung

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

Datentyp

boolean

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

Swelling size (mm)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
Pain ( PA )
Beschreibung

Pain ( PA )

Datentyp

boolean

Alias
UMLS CUI [1]
C0030193
Pain intensity
Beschreibung

Pain intensity

Datentyp

integer

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

Local symptoms ongoing after day 14

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0205276
Date of last Day of Symptoms
Beschreibung

Date of last Day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medical advice
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

HO: Hospitalization ER: Emergency room MD: Medical doctor

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
Solicited adverse events - General symptoms
Beschreibung

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?
Beschreibung

Occurrence of symptoms during the solicited period

Datentyp

integer

Alias
UMLS CUI [1]
C1457887
General symptoms
Beschreibung

General symptoms

Alias
UMLS CUI-1
C0159028
General symptoms
Beschreibung

General symptoms

Datentyp

integer

Alias
UMLS CUI [1]
C0159028
Fever, diagnosis
Beschreibung

Fever, diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0015967
Fever, site of measurement
Beschreibung

Fever, site of measurement

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449687
UMLS CUI [1,2]
C0015967
Fever (FE)
Beschreibung

Axillary > 37.5°C Oral > 37.5°C

Datentyp

float

Alias
UMLS CUI [1]
C0015967
Fatigue (FA)
Beschreibung

Fatigue (FA)

Datentyp

boolean

Alias
UMLS CUI [1]
C0015672
Fatigue intensity
Beschreibung

Fatigue intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0522510
Headache (HE)
Beschreibung

Headache (HE)

Datentyp

boolean

Alias
UMLS CUI [1]
C0018681
Headache, intensity
Beschreibung

Headache, intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0522510
Gastrointestinal symptoms (GI)
Beschreibung

Gastrointestinal symptoms (GI)

Datentyp

boolean

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms, intensity
Beschreibung

Gastrointestinal symptoms, intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0522510
Ongoing after day 14?
Beschreibung

General symptoms ongoing after day 14

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0549178
Date of last day of Symptoms
Beschreibung

Date of last day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0159028
Causality?
Beschreibung

Causality

Datentyp

boolean

Alias
UMLS CUI [1]
C0015127
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type, medical advice

Datentyp

integer

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

Contact person

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

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.

Datentyp

boolean

Alias
UMLS CUI [1]
C0420309
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Ähnliche Modelle

GSK Study ID 100406/004 Visit 1

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Blood sample taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Blood sample date
Item
Please complete only if different from visit date
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item
Has a urine sample been taken?
integer
C0200354 (UMLS CUI [1])
Urine sample 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)
Urin sample date
Item
Please complete only if different from visit date:
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C1274040 (UMLS CUI [1])
Urin sample results
Code List
Result
CL Item
negative (1)
CL Item
positive (2)
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item
Route
integer
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
Axillary (preferred) (1)
CL Item
Oral (2)
Item Group
Vaccine adminstration
C2368628 (UMLS CUI-1)
Vaccine administration date
Item
Please complete only if different from visit date:
date
C0011008 (UMLS CUI [1])
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)
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 N°
integer
C1518404 (UMLS CUI [1])
Non-serious Adverse Event
Code List
Please specify AE N°
CL Item
Unsolicited (1)
CL Item
Solicited (2)
Non-serious adverse event, unsolicited
Item
Please specify AE N° (Unsol.):
integer
C1518404 (UMLS CUI [1])
Non-serious adverse event, solicited
Item
Please specify AE N° (Solicited)
integer
C1518404 (UMLS CUI [1])
Other events
Item
Other, please specify:
text
C0441471 (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])
C1518404 (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)
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Measurement
Code List
Local symptoms
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)
Redness
Item
Redness ( RE )
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness size (mm)
Item
Redness size (mm)
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ( SW )
Item
Swelling ( SW )
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling size (mm)
Item
Swelling size (mm)
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain ( PA )
Item
Pain ( PA )
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity
Code List
Pain intensity
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Local symptoms ongoing after day 14
Item
Ongoing after day 14?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0205276 (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])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
Item
Type
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type
Code List
Type
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (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)
Item
General symptoms
integer
C0159028 (UMLS CUI [1])
Measurement
Code List
General symptoms
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)
Fever, diagnosis
Item
Fever, diagnosis
boolean
C0011900 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever, site of measurement
integer
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever, site of measurement
Code List
Fever, site of measurement
CL Item
Axillary (preferred) (1)
CL Item
Oral (2)
CL Item
Not taken (3)
Fever (FE)
Item
Fever (FE)
float
C0015967 (UMLS CUI [1])
Fatigue (FA)
Item
Fatigue (FA)
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue intensity
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fatigue intensity
Code List
Fatigue intensity
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Headache (HE)
Item
Headache (HE)
boolean
C0018681 (UMLS CUI [1])
Item
Headache, intensity
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Headache, intensity
Code List
Headache, intensity
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Gastrointestinal symptoms (GI)
Item
Gastrointestinal symptoms (GI)
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms, intensity
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Gastrointestinal symptoms, intensity
Code List
Gastrointestinal symptoms, intensity
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
General symptoms ongoing after day 14
Item
Ongoing after day 14?
boolean
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of Symptoms
Item
Date of last day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type
Code List
Type
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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