ID

44384

Beschreibung

Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Stichworte

Versionen (2)
  1. 24.10.19 24.10.19 -
  2. 20.09.21 20.09.21 -
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GlaxoSmithKline

Hochgeladen am

20. September 2021

DOI

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Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)

Englisch

Annex 2: RAP version of cleaning report defining ELIM code criterion to use

1 Formulare  
RAP version of cleaning report defining ELIM code criterion to use
Beschreibung

RAP version of cleaning report defining ELIM code criterion to use

Alias
UMLS CUI-1
C1947930
UMLS CUI-2
C0684224
UMLS CUI-3
C0805701
UMLS CUI-4
C0243161
Cleaning scope
Beschreibung

Cleaning scope

Datentyp

integer

Alias
UMLS CUI [1,1]
C1947930
UMLS CUI [1,2]
C1710028
If other cleaning scope, please specify
Beschreibung

If other cleaning scope, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1947930
UMLS CUI [1,2]
C1710028
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Cleaning Level
Beschreibung

Cleaning Level

Datentyp

integer

Alias
UMLS CUI [1,1]
C1947930
UMLS CUI [1,2]
C0441889
Cleaning site
Beschreibung

Cleaning site

Datentyp

integer

Alias
UMLS CUI [1,1]
C1947930
UMLS CUI [1,2]
C0205145
If other cleaning site, please specify
Beschreibung

If other cleaning site, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1947930
UMLS CUI [1,2]
C0205145
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Summary
Beschreibung

Summary

Alias
UMLS CUI-1
C0242482
Nr of subjects enrolled
Beschreibung

Nr of subjects enrolled

Datentyp

integer

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0237753
Nr of subjects completed
Beschreibung

Nr of subjects completed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205197
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0237753
Nr of subjects drop-outs
Beschreibung

Nr of subjects drop-outs

Datentyp

integer

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0457454
Serious adverse events
Beschreibung

Serious adverse events

Alias
UMLS CUI-1
C1518404
Total Nr of subjects with SAEs
Beschreibung

Total Nr of subjects with SAEs

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0681850
Nr of SAEs related and possibly related to vaccination
Beschreibung

(subject number : …..)

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0042196
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0237753
UMLS CUI [2,3]
C0332149
UMLS CUI [2,4]
C0042196
Nr of SAEs leading to withdrawal from the study
Beschreibung

(subject number : …..)

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0422727
Nr of SAEs still ongoing at the end of the study
Beschreibung

(subjets numbers : …….)

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0008972
UMLS CUI [1,5]
C0444930
SAE Comments
Beschreibung

SAE Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Pregnancies
Beschreibung

Pregnancies

Alias
UMLS CUI-1
C0032961
Nr of pregnancies
Beschreibung

Nr of pregnancies

Datentyp

integer

Alias
UMLS CUI [1]
C3812254
Comments, data not available in the unsolicited AE section
Beschreibung

Comments, data not available in the unsolicited AE section

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1883066
UMLS CUI [1,3]
C0877248
Elimination from safety and immunology analysis
Beschreibung

Elimination from safety and immunology analysis

Alias
UMLS CUI-1
C0036043
UMLS CUI-2
C0936012
UMLS CUI-4
C0152036
UMLS CUI-5
C0936012
Subject or vaccine number not allocated; Vaccine not administered at all; No subject allocated to the randomised number - Subject
Beschreibung

Code 1010

Datentyp

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C1706778
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0237753
UMLS CUI [2,3]
C1706778
UMLS CUI [3]
C2368628
UMLS CUI [4,1]
C2348585
UMLS CUI [4,2]
C1706778
UMLS CUI [4,3]
C0034656
UMLS CUI [4,4]
C0237753
UMLS CUI [5]
C0681850
Subject or vaccine number not allocated; Vaccine not administered at all; No subject allocated to the randomised number - Comments
Beschreibung

Code 1010

Datentyp

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C1706778
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0237753
UMLS CUI [2,3]
C1706778
UMLS CUI [3]
C2368628
UMLS CUI [4,1]
C2348585
UMLS CUI [4,2]
C1706778
UMLS CUI [4,3]
C0034656
UMLS CUI [4,4]
C0237753
UMLS CUI [5]
C0947611
Study vaccine dose not administered AT ALL but subject number allocated - Subject
Beschreibung

Code 1030

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C2348585
UMLS CUI [2,2]
C1706778
UMLS CUI [3]
C0681850
Study vaccine dose not administered AT ALL but subject number allocated - Comments
Beschreibung

Code 1030

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C2348585
UMLS CUI [2,2]
C1706778
UMLS CUI [3]
C0947611
Administration of concomitant vaccine(s) forbidden in the protocol (see also eligibility criteria) ) - Subject
Beschreibung

Code 1040

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2348563
UMLS CUI [2]
C0681850
Administration of concomitant vaccine(s) forbidden in the protocol (see also eligibility criteria) ) - Comments
Beschreibung

Code 1040

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2348563
UMLS CUI [2]
C0947611
Randomisation failure (subject not randomized in the correct group) - Subject
Beschreibung

Code 1050

Datentyp

text

Alias
UMLS CUI [1]
C0034656
UMLS CUI [2]
C0681850
Randomisation failure (subject not randomized in the correct group) - Comments
Beschreibung

Code 1050 subject will not be excluded for this code but group will be corrected

Datentyp

text

Alias
UMLS CUI [1]
C0034656
UMLS CUI [2]
C0947611
Randomisation code broken at the investigator site (only for blinded study) - Subject
Beschreibung

Code 1060

Datentyp

text

Alias
UMLS CUI [1,1]
C3899531
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C0205145
UMLS CUI [2]
C0681850
Randomisation code broken at the investigator site (only for blinded study) - Comments
Beschreibung

Code 1060

Datentyp

text

Alias
UMLS CUI [1,1]
C3899531
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C0205145
UMLS CUI [2]
C0947611
Study vaccine dose not administered according to protocol - Subject
Beschreibung

Code 1070 - route of study vaccine administration wrong or unknown - Replacement vial used NOT corresponding to the correct randomization group - Subject number not in the randomization list and not requested by the sponsor - Extra PID - Wrong vaccine vials given

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0681850
Study vaccine dose not administered according to protocol - Comments
Beschreibung

Code 1070 - route of study vaccine administration wrong or unknown - Replacement vial used NOT corresponding to the correct randomization group - Subject number not in the randomization list and not requested by the sponsor - Extra PID - Wrong vaccine vials given

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0947611
Other (specify) - Subject
Beschreibung

Code 1500

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [2]
C0681850
Other (specify) - Comments
Beschreibung

Code 1500

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [2]
C0681850
Elimination from immunology analysis
Beschreibung

Elimination from immunology analysis

Alias
UMLS CUI-1
C0152036
UMLS CUI-2
C0936012
Protocol violation linked to the inclusion/exclusion criteria including age and excluding codes mentioned below - Subject
Beschreibung

Code 2010

Datentyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C1512693
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0805701
UMLS CUI [4]
C0681850
Protocol violation linked to the inclusion/exclusion criteria including age and excluding codes mentioned below - Comments
Beschreibung

Code 2010

Datentyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C1512693
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0805701
UMLS CUI [4]
C0947611
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP…)
Beschreibung

Code 2020 Please specify the applicable rule

Datentyp

integer

Alias
UMLS CUI [1,1]
C0521143
UMLS CUI [1,2]
C0205265
UMLS CUI [2,1]
C0439673
UMLS CUI [2,2]
C0003241
UMLS CUI [2,3]
C0205265
UMLS CUI [3]
C0019054
UMLS CUI [4,1]
C0449468
UMLS CUI [4,2]
C0231180
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Schedule
Beschreibung

Code 2020

Datentyp

text

Alias
UMLS CUI [1,1]
C0521143
UMLS CUI [1,2]
C0205265
UMLS CUI [2,1]
C0439673
UMLS CUI [2,2]
C0003241
UMLS CUI [2,3]
C0205265
UMLS CUI [3]
C0019054
UMLS CUI [4,1]
C0449468
UMLS CUI [4,2]
C0231180
UMLS CUI [5]
C0086960
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Blood sample
Beschreibung

Code 2020

Datentyp

text

Alias
UMLS CUI [1,1]
C0521143
UMLS CUI [1,2]
C0205265
UMLS CUI [2,1]
C0439673
UMLS CUI [2,2]
C0003241
UMLS CUI [2,3]
C0205265
UMLS CUI [3]
C0019054
UMLS CUI [4,1]
C0449468
UMLS CUI [4,2]
C0231180
UMLS CUI [5]
C1277698
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Antigen
Beschreibung

Code 2020

Datentyp

text

Alias
UMLS CUI [1,1]
C0521143
UMLS CUI [1,2]
C0205265
UMLS CUI [2,1]
C0439673
UMLS CUI [2,2]
C0003241
UMLS CUI [2,3]
C0205265
UMLS CUI [3]
C0019054
UMLS CUI [4,1]
C0449468
UMLS CUI [4,2]
C0231180
UMLS CUI [5]
C0003320
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Cut-off
Beschreibung

Code 2020

Datentyp

text

Alias
UMLS CUI [1,1]
C0521143
UMLS CUI [1,2]
C0205265
UMLS CUI [2,1]
C0439673
UMLS CUI [2,2]
C0003241
UMLS CUI [2,3]
C0205265
UMLS CUI [3]
C0019054
UMLS CUI [4,1]
C0449468
UMLS CUI [4,2]
C0231180
UMLS CUI [5]
C2964552
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Subject
Beschreibung

Code 2020

Datentyp

text

Alias
UMLS CUI [1,1]
C0521143
UMLS CUI [1,2]
C0205265
UMLS CUI [2,1]
C0439673
UMLS CUI [2,2]
C0003241
UMLS CUI [2,3]
C0205265
UMLS CUI [3]
C0019054
UMLS CUI [4,1]
C0449468
UMLS CUI [4,2]
C0231180
UMLS CUI [5]
C0681850
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Comments
Beschreibung

Code 2020

Datentyp

text

Alias
UMLS CUI [1,1]
C0521143
UMLS CUI [1,2]
C0205265
UMLS CUI [2,1]
C0439673
UMLS CUI [2,2]
C0003241
UMLS CUI [2,3]
C0205265
UMLS CUI [3]
C0019054
UMLS CUI [4,1]
C0449468
UMLS CUI [4,2]
C0231180
UMLS CUI [5]
C0947611
Biochemistry, haematology and other laboratory values outside range before any vaccination
Beschreibung

Code 2030 Please specify the applicable rule

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C3845292
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0332152
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C3845292
UMLS CUI [2,3]
C0042196
UMLS CUI [2,4]
C0332152
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C3845292
UMLS CUI [3,3]
C0042196
UMLS CUI [3,4]
C0332152
Biochemistry, haematology and other laboratory values outside range before any vaccination - Schedule
Beschreibung

Code 2030

Datentyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C3845292
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0332152
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C3845292
UMLS CUI [2,3]
C0042196
UMLS CUI [2,4]
C0332152
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C3845292
UMLS CUI [3,3]
C0042196
UMLS CUI [3,4]
C0332152
UMLS CUI [4]
C0086960
Biochemistry, haematology and other laboratory values outside range before any vaccination - Blood sample
Beschreibung

Code 2030

Datentyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C3845292
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0332152
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C3845292
UMLS CUI [2,3]
C0042196
UMLS CUI [2,4]
C0332152
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C3845292
UMLS CUI [3,3]
C0042196
UMLS CUI [3,4]
C0332152
UMLS CUI [4]
C1277698
Biochemistry, haematology and other laboratory values outside range before any vaccination - Test
Beschreibung

Code 2030

Datentyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C3845292
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0332152
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C3845292
UMLS CUI [2,3]
C0042196
UMLS CUI [2,4]
C0332152
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C3845292
UMLS CUI [3,3]
C0042196
UMLS CUI [3,4]
C0332152
UMLS CUI [4]
C0039593
Biochemistry, haematology and other laboratory values outside range before any vaccination - Normal range
Beschreibung

Code 2030

Datentyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C3845292
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0332152
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C3845292
UMLS CUI [2,3]
C0042196
UMLS CUI [2,4]
C0332152
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C3845292
UMLS CUI [3,3]
C0042196
UMLS CUI [3,4]
C0332152
UMLS CUI [4]
C0086715
Biochemistry, haematology and other laboratory values outside range before any vaccination - Subject
Beschreibung

Code 2030

Datentyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C3845292
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0332152
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C3845292
UMLS CUI [2,3]
C0042196
UMLS CUI [2,4]
C0332152
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C3845292
UMLS CUI [3,3]
C0042196
UMLS CUI [3,4]
C0332152
UMLS CUI [4]
C0681850
Biochemistry, haematology and other laboratory values outside range before any vaccination - Comments
Beschreibung

Code 2030

Datentyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C3845292
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0332152
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C3845292
UMLS CUI [2,3]
C0042196
UMLS CUI [2,4]
C0332152
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C3845292
UMLS CUI [3,3]
C0042196
UMLS CUI [3,4]
C0332152
UMLS CUI [4]
C0947611
Administration of any medication forbidden by the protocol - Subject
Beschreibung

Code 2040 (responsibility of CDM following review of individual data listings)

Datentyp

text

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0525058
UMLS CUI [2]
C0681850
Administration of any medication forbidden by the protocol - Comments
Beschreibung

Code 2040 (responsibility of CDM following review of individual data listings)

Datentyp

text

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0525058
UMLS CUI [2]
C0947611
Underlying medical condition forbidden by the protocol - Subject
Beschreibung

Code 2050 (responsibility of CDM following review of individual data listings)

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0525058
UMLS CUI [2]
C0681850
Underlying medical condition forbidden by the protocol - Comments
Beschreibung

Code 2050 (responsibility of CDM following review of individual data listings)

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0525058
UMLS CUI [2]
C0947611
Concomitant infection related to the vaccine which may influence immune response - Subject
Beschreibung

Code 2060 (responsibility of CDM following review of individual data listings)

Datentyp

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0042210
UMLS CUI [2]
C0020964
UMLS CUI [3]
C0681850
Concomitant infection related to the vaccine which may influence immune response - Comments
Beschreibung

Code 2060 (responsibility of CDM following review of individual data listings)

Datentyp

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0042210
UMLS CUI [2]
C0020964
UMLS CUI [3]
C0947611
Infection related to any of the vaccine component (e.g. lyme infection in a lyme study) - Subject
Beschreibung

Code 2060 (responsibility of CDM following review of individual data listings)

Datentyp

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0869014
UMLS CUI [1,3]
C0042210
UMLS CUI [1,4]
C1705248
UMLS CUI [2]
C0024198
UMLS CUI [3]
C0681850
Infection related to any of the vaccine component (e.g. lyme infection in a lyme study) - Comments
Beschreibung

Code 2060 (responsibility of CDM following review of individual data listings)

Datentyp

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0869014
UMLS CUI [1,3]
C0042210
UMLS CUI [1,4]
C1705248
UMLS CUI [2]
C0024198
UMLS CUI [3]
C0947611
Concomitant infection not related to the vaccine which may influence immune response (e.g. Hepatitis infection in a lyme study) - Subject
Beschreibung

Code 2070 (responsibility of CDM following review of individual data listings)

Datentyp

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0869014
UMLS CUI [1,3]
C0042210
UMLS CUI [2]
C0020964
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0681850
Concomitant infection not related to the vaccine which may influence immune response (e.g. Hepatitis infection in a lyme study) - Comments
Beschreibung

Code 2070 (responsibility of CDM following review of individual data listings)

Datentyp

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0869014
UMLS CUI [1,3]
C0042210
UMLS CUI [2]
C0020964
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0947611
Non compliance with vaccination schedules - Subject
Beschreibung

Code 2080 (dates of vaccination not corresponding to adapted protocol intervals or unknown vaccination dates)

Datentyp

text

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0086960
UMLS CUI [2]
C0681850
Non compliance with vaccination schedules - Comments
Beschreibung

Code 2080 (dates of vaccination not corresponding to adapted protocol intervals or unknown vaccination dates)

Datentyp

text

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0086960
UMLS CUI [2]
C0947611
Non compliance with blood sampling schedules - Subject
Beschreibung

Code 2090 (dates of BS not corresponding to adapted protocol intervals or unknown BS dates)

Datentyp

text

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0086960
UMLS CUI [2]
C0681850
Non compliance with blood sampling schedules - Comments
Beschreibung

Code 2090 (dates of BS not corresponding to adapted protocol intervals or unknown BS dates)

Datentyp

text

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0086960
UMLS CUI [2]
C0947611
Serological results not available for antigens POST vaccination
Beschreibung

Code 2100 (including BS lost, Not Done, unable to test, absence of parallelism,….) Please specify the applicable rule:

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205473
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C0686905
UMLS CUI [1,4]
C0042196
UMLS CUI [1,5]
C0003320
UMLS CUI [1,6]
C0687676
Serological results not available for antigens POST vaccination - Schedule
Beschreibung

Code 2100 (including BS lost, Not Done, unable to test, absence of parallelism,...)

Datentyp

text

Alias
UMLS CUI [1,1]
C0205473
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C0686905
UMLS CUI [1,4]
C0042196
UMLS CUI [1,5]
C0003320
UMLS CUI [1,6]
C0687676
UMLS CUI [2]
C0086960
Serological results not available for antigens POST vaccination - Blood sample
Beschreibung

Code 2100 (including BS lost, Not Done, unable to test, absence of parallelism,...)

Datentyp

text

Alias
UMLS CUI [1,1]
C0205473
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C0686905
UMLS CUI [1,4]
C0042196
UMLS CUI [1,5]
C0003320
UMLS CUI [1,6]
C0687676
UMLS CUI [2]
C1277698
Serological results not available for antigens POST vaccination - Antigen
Beschreibung

Code 2100 (including BS lost, Not Done, unable to test, absence of parallelism,...)

Datentyp

text

Alias
UMLS CUI [1,1]
C0205473
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C0686905
UMLS CUI [1,4]
C0042196
UMLS CUI [1,5]
C0003320
UMLS CUI [1,6]
C0687676
UMLS CUI [2]
C0003320
Serological results not available for antigens POST vaccination - Subject
Beschreibung

Code 2100 (including BS lost, Not Done, unable to test, absence of parallelism,...)

Datentyp

text

Alias
UMLS CUI [1,1]
C0205473
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C0686905
UMLS CUI [1,4]
C0042196
UMLS CUI [1,5]
C0003320
UMLS CUI [1,6]
C0687676
UMLS CUI [2]
C0681850
Serological results not available for antigens POST vaccination - Comments
Beschreibung

Code 2100 (including BS lost, Not Done, unable to test, absence of parallelism,...)

Datentyp

text

Alias
UMLS CUI [1,1]
C0205473
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C0686905
UMLS CUI [1,4]
C0042196
UMLS CUI [1,5]
C0003320
UMLS CUI [1,6]
C0687676
UMLS CUI [2]
C0947611
Essential serological temporarily missing because of not yet tested - Antigen
Beschreibung

Code 2110 (interim analysis only)

Datentyp

text

Alias
UMLS CUI [1,1]
C0205473
UMLS CUI [1,2]
C0205224
UMLS CUI [1,3]
C1705492
UMLS CUI [2]
C3640292
UMLS CUI [3]
C0003320
Essential serological temporarily missing because of not yet tested - Subject
Beschreibung

Code 2110 (interim analysis only)

Datentyp

text

Alias
UMLS CUI [1,1]
C0205473
UMLS CUI [1,2]
C0205224
UMLS CUI [1,3]
C1705492
UMLS CUI [2]
C3640292
UMLS CUI [3]
C0681850
Essential serological temporarily missing because of not yet tested - Comments
Beschreibung

Code 2110 (interim analysis only)

Datentyp

text

Alias
UMLS CUI [1,1]
C0205473
UMLS CUI [1,2]
C0205224
UMLS CUI [1,3]
C1705492
UMLS CUI [2]
C3640292
UMLS CUI [3]
C0947611
Obvious incoherence, abnormal serology evolution or error in data - Subject
Beschreibung

Code 2120 (incoherence between CRF and results, wrong labeling in BS)

Datentyp

text

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0036743
UMLS CUI [2,2]
C0205161
UMLS CUI [3]
C1554170
UMLS CUI [4]
C0681850
Obvious incoherence, abnormal serology evolution or error in data - Comments
Beschreibung

Code 2120 (incoherence between CRF and results, wrong labeling in BS)

Datentyp

text

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0036743
UMLS CUI [2,2]
C0205161
UMLS CUI [3]
C1554170
UMLS CUI [4]
C0947611
Subjects not planned in the protocol to be bled for their all blood sampling visits - Subject
Beschreibung

Code 2130

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0681850
UMLS CUI [1,4]
C1301732
UMLS CUI [2]
C0681850
Subjects not planned in the protocol to be bled for their all blood sampling visits - Comments
Beschreibung

Code 2130

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0681850
UMLS CUI [1,4]
C1301732
UMLS CUI [2]
C0947611
Other (specify) - Subject
Beschreibung

Code 2500

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [2]
C0681850
Other (specify) - Comments
Beschreibung

Code 2500

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [2]
C0947611
Extra Elimination from analysis
Beschreibung

Extra Elimination from analysis

Alias
UMLS CUI-1
C0936012
UMLS CUI-2
C2735304
Code
Beschreibung

Code

Datentyp

text

Alias
UMLS CUI [1]
C0805701
Description
Beschreibung

Description

Datentyp

text

Alias
UMLS CUI [1]
C0678257
Subject
Beschreibung

Subject

Datentyp

text

Alias
UMLS CUI [1]
C0681850
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Other points to consider - Inform Consent procedure not respected
Beschreibung

Other points to consider - Inform Consent procedure not respected

Alias
UMLS CUI-1
C0750591
UMLS CUI-2
C0205394
UMLS CUI-3
C0021430
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Problem
Beschreibung

Problem

Datentyp

text

Alias
UMLS CUI [1]
C0033213
Oral IC date if available
Beschreibung

Oral IC date if available

Datentyp

date

Alias
UMLS CUI [1,1]
C3846158
UMLS CUI [1,2]
C0011008
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Other points to consider
Beschreibung

Other points to consider

Alias
UMLS CUI-1
C0750591
UMLS CUI-2
C0205394
Subjects who did not perform their last visit at least 30 days after last vaccination, specify subject numbers
Beschreibung

Subjects who did not perform their last visit at least 30 days after last vaccination, specify subject numbers

Datentyp

text

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C0687676
UMLS CUI [3]
C2348585
Subjects with numbered replacements or wrong vials (version < 12.1)
Beschreibung

Subjects with numbered replacements or wrong vials (version < 12.1)

Datentyp

text

Alias
UMLS CUI [1]
C0681850
UMLS CUI [2,1]
C0184301
UMLS CUI [2,2]
C0559956
UMLS CUI [3,1]
C0184301
UMLS CUI [3,2]
C3827420
Replacement Treatment Number
Beschreibung

Replacement Treatment Number

Alias
UMLS CUI-1
C0559956
UMLS CUI-2
C0087111
UMLS CUI-3
C0237753
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Replacement Treatment Number
Beschreibung

Replacement Treatment Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0559956
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0237753
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Pending Queries not to be resolved
Beschreibung

Pending Queries not to be resolved

Alias
UMLS CUI-1
C1522634
UMLS CUI-2
C1611271
UMLS CUI-3
C3714811
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Query Id
Beschreibung

Query Id

Datentyp

text

Alias
UMLS CUI [1,1]
C1522634
UMLS CUI [1,2]
C0600091
Reason for not sending
Beschreibung

Reason for not sending

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1522634
UMLS CUI [1,3]
C2826287
UMLS CUI [1,4]
C1519246
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Others
Beschreibung

Others

Alias
UMLS CUI-1
C0205394
Others
Beschreibung

Others

Datentyp

text

Alias
UMLS CUI [1]
C0205394
Signature
Beschreibung

Signature

Alias
UMLS CUI-1
C1519316
CDR signature
Beschreibung

CDR signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
CLC\ CSC signature
Beschreibung

CLC\ CSC signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Date of meeting
Beschreibung

Date of meeting

Datentyp

date

Alias
UMLS CUI [1,1]
C0556656
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Annex 2: RAP version of cleaning report defining ELIM code criterion to use

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
RAP version of cleaning report defining ELIM code criterion to use
C1947930 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
C0805701 (UMLS CUI-3)
C0243161 (UMLS CUI-4)
Item
Cleaning scope
integer
C1947930 (UMLS CUI [1,1])
C1710028 (UMLS CUI [1,2])
Cleaning scope
Code List
Cleaning scope
CL Item
Interim analysis  (1)
CL Item
Active phase (all subjects, all data)  (2)
CL Item
Safety follow-up  (3)
CL Item
Immunology  (4)
CL Item
Other: specify (5)
If other cleaning scope, please specify
Item
If other cleaning scope, please specify
text
C1947930 (UMLS CUI [1,1])
C1710028 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Cleaning Level
integer
C1947930 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
Cleaning Level
Code List
Cleaning Level
CL Item
Full cleaning (1)
CL Item
Abridged cleaning (2)
CL Item
Abridged cleaning - Automatic (3)
CL Item
Abridged cleaning - Manual (4)
CL Item
Abridged cleaning - Only SAE cleaned (5)
Item
Cleaning site
integer
C1947930 (UMLS CUI [1,1])
C0205145 (UMLS CUI [1,2])
Cleaning site
Code List
Cleaning site
CL Item
Rixensart (1)
CL Item
CDMCI (2)
CL Item
Other (3)
If other cleaning site, please specify
Item
If other cleaning site, please specify
text
C1947930 (UMLS CUI [1,1])
C0205145 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Summary
C0242482 (UMLS CUI-1)
Nr of subjects enrolled
Item
Nr of subjects enrolled
integer
C1516879 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Nr of subjects completed
Item
Nr of subjects completed
integer
C0205197 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Nr of subjects drop-outs
Item
Nr of subjects drop-outs
integer
C0681850 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
Item Group
Serious adverse events
C1518404 (UMLS CUI-1)
Total Nr of subjects with SAEs
Item
Total Nr of subjects with SAEs
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
Nr of SAEs related and possibly related to vaccination
Item
Nr of SAEs related and possibly related to vaccination
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
C0042196 (UMLS CUI [2,4])
Nr of SAEs leading to withdrawal from the study
Item
Nr of SAEs leading to withdrawal from the study
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0422727 (UMLS CUI [1,3])
Nr of SAEs still ongoing at the end of the study
Item
Nr of SAEs still ongoing at the end of the study
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
C0444930 (UMLS CUI [1,5])
SAE Comments
Item
SAE Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Pregnancies
C0032961 (UMLS CUI-1)
Nr of pregnancies
Item
Nr of pregnancies
integer
C3812254 (UMLS CUI [1])
Comments, data not available in the unsolicited AE section
Item
Comments, data not available in the unsolicited AE section
text
C0947611 (UMLS CUI [1,1])
C1883066 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Item Group
Elimination from safety and immunology analysis
C0036043 (UMLS CUI-1)
C0936012 (UMLS CUI-2)
C0152036 (UMLS CUI-4)
C0936012 (UMLS CUI-5)
Subject or vaccine number not allocated; Vaccine not administered at all; No subject allocated to the randomised number - Subject
Item
Subject or vaccine number not allocated; Vaccine not administered at all; No subject allocated to the randomised number - Subject
text
C2348585 (UMLS CUI [1,1])
C1706778 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C1706778 (UMLS CUI [2,3])
C2368628 (UMLS CUI [3])
C2348585 (UMLS CUI [4,1])
C1706778 (UMLS CUI [4,2])
C0034656 (UMLS CUI [4,3])
C0237753 (UMLS CUI [4,4])
C0681850 (UMLS CUI [5])
Subject or vaccine number not allocated; Vaccine not administered at all; No subject allocated to the randomised number - Comments
Item
Subject or vaccine number not allocated; Vaccine not administered at all; No subject allocated to the randomised number - Comments
text
C2348585 (UMLS CUI [1,1])
C1706778 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C1706778 (UMLS CUI [2,3])
C2368628 (UMLS CUI [3])
C2348585 (UMLS CUI [4,1])
C1706778 (UMLS CUI [4,2])
C0034656 (UMLS CUI [4,3])
C0237753 (UMLS CUI [4,4])
C0947611 (UMLS CUI [5])
Study vaccine dose not administered AT ALL but subject number allocated - Subject
Item
Study vaccine dose not administered AT ALL but subject number allocated - Subject
text
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348585 (UMLS CUI [2,1])
C1706778 (UMLS CUI [2,2])
C0681850 (UMLS CUI [3])
Study vaccine dose not administered AT ALL but subject number allocated - Comments
Item
Study vaccine dose not administered AT ALL but subject number allocated - Comments
text
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348585 (UMLS CUI [2,1])
C1706778 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
Administration of concomitant vaccine(s) forbidden in the protocol (see also eligibility criteria) - Subject
Item
Administration of concomitant vaccine(s) forbidden in the protocol (see also eligibility criteria) ) - Subject
text
C2368628 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2])
Administration of concomitant vaccine(s) forbidden in the protocol (see also eligibility criteria) ) - Comments
Item
Administration of concomitant vaccine(s) forbidden in the protocol (see also eligibility criteria) ) - Comments
text
C2368628 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Randomisation failure (subject not randomized in the correct group) - Subject
Item
Randomisation failure (subject not randomized in the correct group) - Subject
text
C0034656 (UMLS CUI [1])
C0681850 (UMLS CUI [2])
Randomisation failure (subject not randomized in the correct group) - Comments
Item
Randomisation failure (subject not randomized in the correct group) - Comments
text
C0034656 (UMLS CUI [1])
C0947611 (UMLS CUI [2])
Randomisation code broken at the investigator site (only for blinded study) - Subject
Item
Randomisation code broken at the investigator site (only for blinded study) - Subject
text
C3899531 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2])
Randomisation code broken at the investigator site (only for blinded study) - Comments
Item
Randomisation code broken at the investigator site (only for blinded study) - Comments
text
C3899531 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Study vaccine dose not administered according to protocol - Subject
Item
Study vaccine dose not administered according to protocol - Subject
text
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2])
Study vaccine dose not administered according to protocol - Comments
Item
Study vaccine dose not administered according to protocol - Comments
text
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Other (specify) - Subject
Item
Other (specify) - Subject
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2])
Other (specify) - Comments
Item
Other (specify) - Comments
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2])
Item Group
Elimination from immunology analysis
C0152036 (UMLS CUI-1)
C0936012 (UMLS CUI-2)
Protocol violation linked to the inclusion/exclusion criteria including age and excluding codes mentioned below - Subject
Item
Protocol violation linked to the inclusion/exclusion criteria including age and excluding codes mentioned below - Subject
text
C1709750 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C0805701 (UMLS CUI [3])
C0681850 (UMLS CUI [4])
Protocol violation linked to the inclusion/exclusion criteria including age and excluding codes mentioned below - Comments
Item
Protocol violation linked to the inclusion/exclusion criteria including age and excluding codes mentioned below - Comments
text
C1709750 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C0805701 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
Item
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP…)
integer
C0521143 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0439673 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C0019054 (UMLS CUI [3])
C0449468 (UMLS CUI [4,1])
C0231180 (UMLS CUI [4,2])
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP…) - Subject
Code List
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP…)
CL Item
elimination code if all values are positive or unknown (1)
CL Item
elimination code if at least one value is positive or unknown (2)
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Schedule
Item
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Schedule
text
C0521143 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0439673 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C0019054 (UMLS CUI [3])
C0449468 (UMLS CUI [4,1])
C0231180 (UMLS CUI [4,2])
C0086960 (UMLS CUI [5])
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Blood sample
Item
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Blood sample
text
C0521143 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0439673 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C0019054 (UMLS CUI [3])
C0449468 (UMLS CUI [4,1])
C0231180 (UMLS CUI [4,2])
C1277698 (UMLS CUI [5])
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Antigen
Item
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Antigen
text
C0521143 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0439673 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C0019054 (UMLS CUI [3])
C0449468 (UMLS CUI [4,1])
C0231180 (UMLS CUI [4,2])
C0003320 (UMLS CUI [5])
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Cut-off
Item
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Cut-off
text
C0521143 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0439673 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C0019054 (UMLS CUI [3])
C0449468 (UMLS CUI [4,1])
C0231180 (UMLS CUI [4,2])
C2964552 (UMLS CUI [5])
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Subject
Item
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Subject
text
C0521143 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0439673 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C0019054 (UMLS CUI [3])
C0449468 (UMLS CUI [4,1])
C0231180 (UMLS CUI [4,2])
C0681850 (UMLS CUI [5])
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Comments
Item
Initially seropositive OR initially unknown antibody status (pre BS missing or unable to test because of hemolysis, insufficient volume, AP) - Comments
text
C0521143 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0439673 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C0019054 (UMLS CUI [3])
C0449468 (UMLS CUI [4,1])
C0231180 (UMLS CUI [4,2])
C0947611 (UMLS CUI [5])
Item
Biochemistry, haematology and other laboratory values outside range before any vaccination
integer
C0005477 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0018941 (UMLS CUI [2,1])
C3845292 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C1254595 (UMLS CUI [3,1])
C3845292 (UMLS CUI [3,2])
C0042196 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
Biochemistry, haematology and other laboratory values outside range before any vaccination
Code List
Biochemistry, haematology and other laboratory values outside range before any vaccination
CL Item
elimination code if all values are out of range (1)
CL Item
elimination code if at least one value is out of range (2)
Biochemistry, haematology and other laboratory values outside range before any vaccination - Schedule
Item
Biochemistry, haematology and other laboratory values outside range before any vaccination - Schedule
text
C0005477 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0018941 (UMLS CUI [2,1])
C3845292 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C1254595 (UMLS CUI [3,1])
C3845292 (UMLS CUI [3,2])
C0042196 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
C0086960 (UMLS CUI [4])
Biochemistry, haematology and other laboratory values outside range before any vaccination - Blood sample
Item
Biochemistry, haematology and other laboratory values outside range before any vaccination - Blood sample
text
C0005477 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0018941 (UMLS CUI [2,1])
C3845292 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C1254595 (UMLS CUI [3,1])
C3845292 (UMLS CUI [3,2])
C0042196 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
C1277698 (UMLS CUI [4])
Biochemistry, haematology and other laboratory values outside range before any vaccination - Test
Item
Biochemistry, haematology and other laboratory values outside range before any vaccination - Test
text
C0005477 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0018941 (UMLS CUI [2,1])
C3845292 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C1254595 (UMLS CUI [3,1])
C3845292 (UMLS CUI [3,2])
C0042196 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
C0039593 (UMLS CUI [4])
Biochemistry, haematology and other laboratory values outside range before any vaccination - Normal range
Item
Biochemistry, haematology and other laboratory values outside range before any vaccination - Normal range
text
C0005477 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0018941 (UMLS CUI [2,1])
C3845292 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C1254595 (UMLS CUI [3,1])
C3845292 (UMLS CUI [3,2])
C0042196 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
C0086715 (UMLS CUI [4])
Biochemistry, haematology and other laboratory values outside range before any vaccination - Subject
Item
Biochemistry, haematology and other laboratory values outside range before any vaccination - Subject
text
C0005477 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0018941 (UMLS CUI [2,1])
C3845292 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C1254595 (UMLS CUI [3,1])
C3845292 (UMLS CUI [3,2])
C0042196 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
C0681850 (UMLS CUI [4])
Biochemistry, haematology and other laboratory values outside range before any vaccination - Comments
Item
Biochemistry, haematology and other laboratory values outside range before any vaccination - Comments
text
C0005477 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0018941 (UMLS CUI [2,1])
C3845292 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C1254595 (UMLS CUI [3,1])
C3845292 (UMLS CUI [3,2])
C0042196 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
C0947611 (UMLS CUI [4])
Administration of any medication forbidden by the protocol - Subject
Item
Administration of any medication forbidden by the protocol - Subject
text
C3469597 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2])
Administration of any medication forbidden by the protocol - Comments
Item
Administration of any medication forbidden by the protocol - Comments
text
C3469597 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Underlying medical condition forbidden by the protocol - Subject
Item
Underlying medical condition forbidden by the protocol - Subject
text
C0012634 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2])
Underlying medical condition forbidden by the protocol - Comments
Item
Underlying medical condition forbidden by the protocol - Comments
text
C0012634 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Concomitant infection related to the vaccine which may influence immune response - Subject
Item
Concomitant infection related to the vaccine which may influence immune response - Subject
text
C0009450 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0020964 (UMLS CUI [2])
C0681850 (UMLS CUI [3])
Concomitant infection related to the vaccine which may influence immune response - Comments
Item
Concomitant infection related to the vaccine which may influence immune response - Comments
text
C0009450 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0020964 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Infection related to any of the vaccine component (e.g. lyme infection in a lyme study) - Subject
Item
Infection related to any of the vaccine component (e.g. lyme infection in a lyme study) - Subject
text
C0009450 (UMLS CUI [1,1])
C0869014 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
C0024198 (UMLS CUI [2])
C0681850 (UMLS CUI [3])
Infection related to any of the vaccine component (e.g. lyme infection in a lyme study) - Comments
Item
Infection related to any of the vaccine component (e.g. lyme infection in a lyme study) - Comments
text
C0009450 (UMLS CUI [1,1])
C0869014 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
C0024198 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Concomitant infection not related to the vaccine which may influence immune response (e.g. Hepatitis infection in a lyme study) - Subject
Item
Concomitant infection not related to the vaccine which may influence immune response (e.g. Hepatitis infection in a lyme study) - Subject
text
C0009450 (UMLS CUI [1,1])
C0869014 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0020964 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0681850 (UMLS CUI [4])
Concomitant infection not related to the vaccine which may influence immune response (e.g. Hepatitis infection in a lyme study) - Comments
Item
Concomitant infection not related to the vaccine which may influence immune response (e.g. Hepatitis infection in a lyme study) - Comments
text
C0009450 (UMLS CUI [1,1])
C0869014 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0020964 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
Non compliance with vaccination schedules - Subject
Item
Non compliance with vaccination schedules - Subject
text
C0457432 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0086960 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2])
Non compliance with vaccination schedules - Comments
Item
Non compliance with vaccination schedules - Comments
text
C0457432 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0086960 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Non compliance with blood sampling schedules - Subject
Item
Non compliance with blood sampling schedules - Subject
text
C0457432 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0086960 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2])
Non compliance with blood sampling schedules - Comments
Item
Non compliance with blood sampling schedules - Comments
text
C0457432 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0086960 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item
Serological results not available for antigens POST vaccination
integer
C0205473 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C0686905 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0003320 (UMLS CUI [1,5])
C0687676 (UMLS CUI [1,6])
Serological results not available for antigens POST vaccination
Code List
Serological results not available for antigens POST vaccination
CL Item
elimination code if all are missing post-dose 3  (1)
CL Item
elimination code if at least one is missing (2)
Serological results not available for antigens POST vaccination - Schedule
Item
Serological results not available for antigens POST vaccination - Schedule
text
C0205473 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C0686905 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0003320 (UMLS CUI [1,5])
C0687676 (UMLS CUI [1,6])
C0086960 (UMLS CUI [2])
Serological results not available for antigens POST vaccination - Blood sample
Item
Serological results not available for antigens POST vaccination - Blood sample
text
C0205473 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C0686905 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0003320 (UMLS CUI [1,5])
C0687676 (UMLS CUI [1,6])
C1277698 (UMLS CUI [2])
Serological results not available for antigens POST vaccination - Antigen
Item
Serological results not available for antigens POST vaccination - Antigen
text
C0205473 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C0686905 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0003320 (UMLS CUI [1,5])
C0687676 (UMLS CUI [1,6])
C0003320 (UMLS CUI [2])
Serological results not available for antigens POST vaccination - Subject
Item
Serological results not available for antigens POST vaccination - Subject
text
C0205473 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C0686905 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0003320 (UMLS CUI [1,5])
C0687676 (UMLS CUI [1,6])
C0681850 (UMLS CUI [2])
Serological results not available for antigens POST vaccination - Comments
Item
Serological results not available for antigens POST vaccination - Comments
text
C0205473 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C0686905 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0003320 (UMLS CUI [1,5])
C0687676 (UMLS CUI [1,6])
C0947611 (UMLS CUI [2])
Essential serological temporarily missing because of not yet tested - Antigen
Item
Essential serological temporarily missing because of not yet tested - Antigen
text
C0205473 (UMLS CUI [1,1])
C0205224 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
C3640292 (UMLS CUI [2])
C0003320 (UMLS CUI [3])
Essential serological temporarily missing because of not yet tested - Subject
Item
Essential serological temporarily missing because of not yet tested - Subject
text
C0205473 (UMLS CUI [1,1])
C0205224 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
C3640292 (UMLS CUI [2])
C0681850 (UMLS CUI [3])
Essential serological temporarily missing because of not yet tested - Comments
Item
Essential serological temporarily missing because of not yet tested - Comments
text
C0205473 (UMLS CUI [1,1])
C0205224 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
C3640292 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Obvious incoherence, abnormal serology evolution or error in data - Subject
Item
Obvious incoherence, abnormal serology evolution or error in data - Subject
text
C3846158 (UMLS CUI [1])
C0036743 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C1554170 (UMLS CUI [3])
C0681850 (UMLS CUI [4])
Obvious incoherence, abnormal serology evolution or error in data - Comments
Item
Obvious incoherence, abnormal serology evolution or error in data - Comments
text
C3846158 (UMLS CUI [1])
C0036743 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C1554170 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
Subjects not planned in the protocol to be bled for their all blood sampling visits - Subject
Item
Subjects not planned in the protocol to be bled for their all blood sampling visits - Subject
text
C0005834 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0681850 (UMLS CUI [2])
Subjects not planned in the protocol to be bled for their all blood sampling visits - Comments
Item
Subjects not planned in the protocol to be bled for their all blood sampling visits - Comments
text
C0005834 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0947611 (UMLS CUI [2])
Other (specify) - Subject
Item
Other (specify) - Subject
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2])
Other (specify) - Comments
Item
Other (specify) - Comments
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item Group
Extra Elimination from analysis
C0936012 (UMLS CUI-1)
C2735304 (UMLS CUI-2)
Code
Item
Code
text
C0805701 (UMLS CUI [1])
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Subject
Item
Subject
text
C0681850 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Other points to consider - Inform Consent procedure not respected
C0750591 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0021430 (UMLS CUI-3)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Problem
Item
Problem
text
C0033213 (UMLS CUI [1])
Oral IC date if available
Item
Oral IC date if available
date
C3846158 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Other points to consider
C0750591 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Subjects who did not perform their last visit at least 30 days after last vaccination, specify subject numbers
Item
Subjects who did not perform their last visit at least 30 days after last vaccination, specify subject numbers
text
C1512346 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C2348585 (UMLS CUI [3])
Subjects with numbered replacements or wrong vials (version < 12.1)
Item
Subjects with numbered replacements or wrong vials (version < 12.1)
text
C0681850 (UMLS CUI [1])
C0184301 (UMLS CUI [2,1])
C0559956 (UMLS CUI [2,2])
C0184301 (UMLS CUI [3,1])
C3827420 (UMLS CUI [3,2])
Item Group
Replacement Treatment Number
C0559956 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C0237753 (UMLS CUI-3)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Replacement Treatment Number
Item
Replacement Treatment Number
text
C0559956 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Pending Queries not to be resolved
C1522634 (UMLS CUI-1)
C1611271 (UMLS CUI-2)
C3714811 (UMLS CUI-3)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Query Id
Item
Query Id
text
C1522634 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Reason for not sending
Item
Reason for not sending
text
C0392360 (UMLS CUI [1,1])
C1522634 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C1519246 (UMLS CUI [1,4])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Others
C0205394 (UMLS CUI-1)
Others
Item
Others
text
C0205394 (UMLS CUI [1])
Item Group
Signature
C1519316 (UMLS CUI-1)
CDR signature
Item
CDR signature
text
C1519316 (UMLS CUI [1])
CLC\ CSC signature
Item
CLC\ CSC signature
text
C1519316 (UMLS CUI [1])
Date of meeting
Item
Date of meeting
date
C0556656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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