Informatie:
Fout:
ID
25913
Beschrijving
Study ID: 100551 (EXT Y11) Clinical Study ID: 100551 Study Title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289770 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Trefwoorden
Versies (2)
- 26-06-17 26-06-17 -
- 26-09-17 26-09-17 -
Geüploaded op
26 september 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 22 Year 15)
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 22 Year 15)
Similar models
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 22 Year 15)
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Information
Item
Information
text
C1533716 (UMLS CUI [1])
Introductional information
Item
Introductory information read
boolean
C1533716 (UMLS CUI [1,1])
C0579004 (UMLS CUI [1,2])
C0579004 (UMLS CUI [1,2])
Item Group
General medical history / physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
C0031809 (UMLS CUI-3)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Are you aware of any pre-existing conditions or or signs and/or symptoms present in the subject prior to the start of the study?
text
C0009488 (UMLS CUI [1])
Code List
Are you aware of any pre-existing conditions or or signs and/or symptoms present in the subject prior to the start of the study?
CL Item
No (1)
CL Item
Yes (Please choose appropriate box(es)and give diagnosis (2)
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Cutaneous: diagnosis
Item
Cutaneous: diagnosis
text
C0037274 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Eyes: diagnosis
Item
Eyes: diagnosis
text
C0015397 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Ears-Nose-Throat: diagnosis
Item
Ears-Nose-Throat: diagnosis
text
C0395797 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Cardiovascular: diagnosis
Item
Cardiovascular: diagnosis
text
C0007222 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Respiratory: diagnosis
Item
Respiratory: diagnosis
text
C0035204 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Gastrointestinal: diagnosis
Item
Gastrointestinal: diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Muskuloskeletal: diagnosis
Item
Muskuloskeletal: diagnosis
text
C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Neurological: diagnosis
Item
Neurological: diagnosis
text
C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Genitourinary: diagnosis
Item
Genitourinary: diagnosis
text
C0080276 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Haematology: diagnosis
Item
Haematology: diagnosis
text
C0018939 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Hypersensitivity: diagnosis
Item
Allergies: diagnosis
text
C0020517 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Endocrine: diagnosis
Item
Endocrine: diagnosis
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Other (specify)
Item
Other (specify)
text
C3845569 (UMLS CUI [1])
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
CL Item
yes (please answer the following question if different from visit date) (1)
CL Item
no (2)
Collection Date
Item
Date of blood sample
date
C1317250 (UMLS CUI [1])
CL Item
yes (please answer the following question of different from visit date) (1)
CL Item
no (2)
CL Item
NA (not of childbearing potential or male) (3)
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
negative (1)
CL Item
positive (2)
Date of vaccine administration
Item
Date of vaccine administration
date
Pre-vaccination temperature
Item
Pre-vaccination temperature
float
C0005903 (UMLS CUI [1])
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
CL Item
Twinrix™ Adult (720/20) Vaccine (1)
CL Item
Twinrix™ Adult (720/20) Vaccine: Not administered -> Please complete following page (2)
CL Item
Engerix™ (20 μg) Vaccine (3)
CL Item
Engerix™ (20 μg) Vaccine: Not administered -> Please complete following page (4)
CL Item
Havrix™ (720 EL.U)Vaccine (5)
CL Item
Havrix™ (720 EL.U)Vaccine: Not administered -> Please complete following page (6)
Item
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
text
C0595042 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
C0547696 (UMLS CUI [1,2])
Code List
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
CL Item
Yes (1)
CL Item
No (Please tick all Items that apply) (2)
Item
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
text
C0595042 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0547696 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Code List
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
CL Item
Side: left (1)
CL Item
Side: right (2)
CL Item
Site: Deltoid (3)
CL Item
Site: Thigh (4)
CL Item
Site: Buttock (5)
CL Item
Route: I.M. (6)
CL Item
Route: S.C. (7)
Item
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
text
C0116078 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
C0547696 (UMLS CUI [1,2])
Code List
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
CL Item
Side: Left (1)
CL Item
Side: Right (2)
CL Item
Site: Deltoid (3)
CL Item
Site: Thigh (4)
CL Item
Site: Buttock (5)
CL Item
Route: I.M. (6)
CL Item
Route: S.C. (7)
Item
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
text
C0700881 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
C0547696 (UMLS CUI [1,2])
Code List
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
CL Item
Side: Left (1)
CL Item
Side: Right (2)
CL Item
Site: Deltoid (3)
CL Item
Site: Thigh (4)
CL Item
Site: Buttock (5)
CL Item
Route: I.M. (6)
CL Item
Route: S.C. (7)
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Serious adverse event (complete Serious Adverse Event form) (1)
CL Item
Non-serious adverse event (complete the Non-serious Adverse Event section) (2)
CL Item
Other (3)
Specification of reason for non administration
Item
Other, please specify (reason for non administration)
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
CL Item
Investigator (1)
CL Item
Subject (2)
Item Group
Unsolicited adverse events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
CL Item
Information not available (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
Soliticited adverse events - local symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Has the subject experienced any of the following sings/symptoms at the administration site during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Code List
Has the subject experienced any of the following sings/symptoms at the administration site during the solicited period?
CL Item
Information available (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)
CL Item
No (1)
CL Item
Size (please fill in next item) (2)
Erythema: day 0
Item
Local symptoms day 0
float
C0041834 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Erythema: day 1
Item
Local symptoms day 1
float
C0041834 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,2])
Erythema: day 2
Item
Local symptoms day 2
float
C0041834 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,2])
Erythema: day 3
Item
Local symptoms day 3
float
Erythema: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0041834 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Erythema: Date of last day of symptoms
Item
Date of last day of symptoms (redness)
date
C0041834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
CL Item
No (1)
CL Item
Yes (please fill in the next item) (2)
Swelling: day 0
Item
Local symptoms day 0
float
C0038999 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Swelling: day 1
Item
Local symptoms day 1
float
C0038999 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,2])
Swelling: day 2
Item
Local symptoms day 2
float
C0038999 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,2])
Swelling: Local symptoms day 3
Item
Local symptoms day 3
float
C0038999 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,2])
Swelling: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Swelling: Date of last day of symptoms
Item
Date of last day of symptoms (swelling)
date
C0038999 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
CL Item
No (1)
CL Item
Yes, intensity: (please fill in next item) (2)
Item
Intensity of pain day 0
text
C1320357 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity of pain day 1
text
C1320357 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity of pain day 2
text
C1320357 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity of pain day 3
text
C1320357 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Pain: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C1320357 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Pain: Date of last day of symptoms
Item
Date of last day of symptoms (pain)
date
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item Group
Solicid adverse events - general symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (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)
Fever
Item
General symptoms: Fever
boolean
C0015967 (UMLS CUI [1])
Body Temperature
Item
Fever: if yes, please specify amount of fever
float
C0005903 (UMLS CUI [1])
CL Item
Axilary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Fever: day 0
Item
Fever day 0
float
C0015967 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Fever: day 0 Specification
Item
Fever not taken day 0
boolean
C0015967 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: day 1
Item
Fever day 1
float
C0015967 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,2])
Fever: day 1 Specification
Item
Fever not taken day 1
boolean
C0015967 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1442449 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: day 2
Item
Fever day 2
float
C0015967 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,2])
Fever: day 2 Specification
Item
Fever not taken day 2
boolean
C0015967 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C3842676 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: day 3
Item
Fever day 3
float
C0015967 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,2])
Fever: day 3 Specification
Item
Fever not taken day 3
boolean
C0015967 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C3842675 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Fever: Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0015967 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Fever: Causality
Item
Causality
boolean
C0015967 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Yes, please fill in next question (2)
Item
Intensity fatigue day 0
text
C0015672 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity fatigue day 2
text
C0015672 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity fatigue day 3
text
C0015672 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Fatigue: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0015672 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Fatigue: Date of last Day of symptoms
Item
Date of last Day of symptoms
date
C0015672 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Fatigue: Causality
Item
Causality?
boolean
C0015672 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Yes, intensity: please fill in the next items (2)
Item
Intensity headache day 0
text
C0018681 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity headache day 1
text
C0018681 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity headache day 2
text
C0018681 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity headache day 3
text
C0018681 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Headache: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0018681 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Headache: Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Headache: Causality
Item
Causality
boolean
C0018681 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Yes, intensity: please fill in the next items (2)
Item
Intensity gastrointestinal symptoms day 0
text
C0426576 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity gastrointestinal symptoms day 1
text
C0426576 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity gastrointestinal symptoms day 2
text
C0426576 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity gastrointestinal symptoms day 3
text
C0426576 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Gastrointestinal Symptoms: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0426576 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Gastrointestinal Symptoms: Date of last day of symptoms
Item
Date of last day of symptoms
date
C0426576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Gastrointestinal Symptoms: Causality
Item
Causality
boolean
C0426576 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])