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Falhas:
ID
26422
Descrição
Phase III, open, randomized study, in two centres, to demonstrate the equivalence of the 0, 12 month schedule to the 0, 6 month schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A/ hepatitis B vaccine TWINRIX™ ADULT (720 EL. U. of hepatitis A antigen/ 20 μg of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive. NCT00197171
Palavras-chave
Versões (3)
- 17/10/2017 17/10/2017 -
- 20/10/2017 20/10/2017 -
- 20/10/2017 20/10/2017 -
Titular dos direitos
Glaxo Smith Kline
Transferido a
17 de outubro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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GSK Study ID 100386 & 100387 Persistence of immune response to TWINRIX™ ADULT Additional Vaccination Year 6
Additional Vaccination Year 6
- StudyEvent: ODM
Similar models
Additional Vaccination Year 6
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Long Term Follow up Visit 9
C0042196 (UMLS CUI-1)
C0940824 (UMLS CUI-2)
C0940824 (UMLS CUI-2)
Study site identifier
Item
Center
text
C2826692 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Did the subject come at visit 9?
Item
Did the subject come at visit 9?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Other please specify (2)
Item
Please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Other specify
Item
If other please specify
text
C3845569 (UMLS CUI [1])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
CL Item
Investigator (I)
CL Item
Subject (S)
Blood sample
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C0005834 (UMLS CUI [1])
Sample Collection Date
Item
Sample Collection Date
date
C1302413 (UMLS CUI [1])
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (not of childbearing potential or male) (3)
Sample collection Date
Item
Sample collection Date
date
C1302413 (UMLS CUI [1])
CL Item
Positive (1)
CL Item
Negative (2)
Vaccination Date
Item
Date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
Item
Pre-Vaccination temperature
integer
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
CL Item
Axillary (A)
CL Item
Oral (O)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,2])
CL Item
Twinrix Adult (720/20) Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following page) (N)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
CL Item
Left (L)
CL Item
Right (R)
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
CL Item
I.M (im)
CL Item
S.C (sc)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,2])
CL Item
Engerix (20) Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following page) (N)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
CL Item
Left (L)
CL Item
Right (R)
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
CL Item
I.M (im)
CL Item
S.C (sc)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,2])
CL Item
Havrix (720 EL.U) Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following page) (N)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
CL Item
Left (L)
CL Item
Right (R)
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
CL Item
I.M (im)
CL Item
S.C (sc)
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Why not administered? Please tick the ONE most appropriate category for non administration
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Why not administered? Please tick the ONE most appropriate category for non administration
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (OTH)
SAE number
Item
Please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
unsolicited AE number
Item
Please specify unsolicited AE number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
solicited AE code
Item
Please specify solicited AE code
integer
C0877248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other specify
Item
If other please specify
text
C3845569 (UMLS CUI [1])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
CL Item
Investigator (I)
CL Item
Subject (S)
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
No (N)
CL Item
No vaccine administered (NA)
CL Item
Information not available (U)
CL Item
Yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. (Y)
Item Group
Solicited Adverse Events- Local
C0877248 (UMLS CUI-1)
C0853813 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0853813 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Solicited Adverse Events - local symptoms
text
C0877248 (UMLS CUI [1,1])
C0853813 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0853813 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
Local Symptoms
Item
Local Symptoms - Redness
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Local Symptoms
Item
Local Symptoms - Redness Day 0
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Local Symptoms
Item
Local Symptoms - Redness Day 1
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Local Symptoms
Item
Local Symptoms - Redness Day 2
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Local Symptoms
Item
Local Symptoms - Redness Day 3
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Local Symptoms
Item
Local Symptoms - Redness ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
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])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 0
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 1
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 2
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 3
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Local Symptoms
Item
Local Symptoms - Swelling ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
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])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Local Symptoms - Pain
Item
Local Symptoms - Pain
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Item
Local Symptoms - Pain Intensity Day 0
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Local Symptoms - Pain Intensity Day 1
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Local Symptoms - Pain Intensity Day 2
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Local Symptoms - Pain Intensity Day 3
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Local Symptoms
Item
Local Symptoms - Pain ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
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])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
Solicited Adverse Events- General Symptoms
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Solicited Adverse Events- Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Code List
Solicited Adverse Events- Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
General Symptoms - Fever
Item
General Symptoms - Fever
boolean
C0015967 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,2])
Item
If Fever is yes, measurement route
text
C0489453 (UMLS CUI [1])
CL Item
Axillary (A)
CL Item
Oral (O)
Body temperature Day 0
Item
Body temperature Day 0
float
C0005903 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,2])
Body temperature Day 0 not taken
Item
Body temperature Day 0 not taken
boolean
C2826301 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,2])
Body temperature Day 1
Item
Body temperature Day 1
float
C0005903 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,2])
Body temperature Day 1 not taken
Item
Body temperature Day 1 not taken
boolean
C1442449 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,2])
Body temperature Day 2
Item
Body temperature Day 2
float
C0005903 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,2])
Body temperature Day 2 not taken
Item
Body temperature Day 2 not taken
boolean
C3842676 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,2])
Body temperature Day 3
Item
Body temperature Day 3
float
C0005903 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,2])
Body temperature Day 3 not taken
Item
Body temperature Day 3 not taken
boolean
C3842675 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,2])
Ongoing after Day 3
Item
Fever ongoing after Day 3
boolean
C0015967 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
C2826663 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
General Symptoms - Fatigue
Item
General Symptoms - Fatigue
boolean
C0015672 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,2])
Item
Symptom intensity - Fatigue Day 0
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Fatigue Day 1
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Fatigue Day 2
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Fatigue Day 3
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Fatigue: Ongoing after Day 3
Item
Fatigue Ongoing after Day 3
boolean
C0015672 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
C2826663 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
General Symptoms - Headache
Item
General Symptoms - Headache
boolean
C0018681 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,2])
Item
Symptom intensity - Headache Day 0
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Headache Day 1
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Headache Day 2
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Headache Day 3
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Headache: Ongoing after Day 3
Item
Headache Ongoing after Day 3
boolean
C0018681 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
C2826663 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
General Symptoms - Gastrointestinal
Item
Gastrointestinal Symptoms
boolean
C0426576 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,2])
Item
Symptom intensity - Gastrointestinal symptoms Day 0
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Gastrointestinal symptoms Day 1
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Gastrointestinal symptoms Day 2
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Gastrointestinal symptoms Day 3
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Gastrointestinal symptoms: Ongoing after Day 3
Item
Gastrointestinal symptoms Ongoing after Day 3
boolean
C0426576 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
C2826663 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])