Item
(Please report all serious adverse events only on the Serious Adverse Event (SAE) form). Has any non-serious adverse events occurred within one month (minimum 30 days) post vaccination, excluding those recorded on the Solicited Adverse Events pages?
text
C1518404 (UMLS CUI [1])
Code List
(Please report all serious adverse events only on the Serious Adverse Event (SAE) form). Has any non-serious adverse events occurred within one month (minimum 30 days) post vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
Yes, please complete the following table. (Yes, please complete the following table.)
AE No.
Item
AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Site
text
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
[L] Administration site ([L] Administration site)
CL Item
[G] Non-administration site ([G] Non-administration site)
Date Started
Item
Date Started
date
C2697888 (UMLS CUI [1])
Adverse event start
Item
During immediate post-vaccination period (60 minutes)?
boolean
C2697888 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C2697886 (UMLS CUI [1])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
Relationship to investigational products
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Outcome (at the interim analysis timepoint)
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Outcome (at the interim analysis timepoint)
CL Item
[1] Recovered / Resolved (1)
CL Item
[2] Recovering / resolving (2)
CL Item
[3] Not recovered / not resolved (3)
CL Item
[4] Recovered with sequelae / Resolved with sequelae (4)
Serious adverse event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
Total number of SAE's
Item
If you answered the previous question with Yes → Specify total number of SAE's:
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Treatment blind
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Treatment blind broken date
Item
If you answered the previous question with Yes → Complete date and tick one reason below.
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If you answered the previous question with Yes Complete date and tick one reason below.
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If you answered the previous question with Yes Complete date and tick one reason below.
CL Item
[1] Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
[2] Other, specify: _______________________________________________ (2)
Item
Did any elimination criteria become applicable during the study?
integer
Code List
Did any elimination criteria become applicable during the study?
CL Item
Yes → Specify: __________________________________________________________ (2)
Subject withdrawal
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If you answered the previous question with Yes → Please tick the ONE most appropriate category for withdrawal.
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
If you answered the previous question with Yes → Please tick the ONE most appropriate category for withdrawal.
CL Item
[SAE] Serious adverse event (check Serious Adverse Event form) Please specify SAE N°: |__|__| (1)
CL Item
[AEX] Non-Serious adverse event (check the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or solicited AE code: |__|__| (2)
CL Item
[PTV] Protocol violation, please specify: _______________________________________ (3)
CL Item
[CWS] Consent withdrawal, not due to an adverse event. (4)
CL Item
[MIG] Migrated / moved from the study area (5)
CL Item
[LFU] Lost to follow-up. (6)
CL Item
[OTH] Other, please specify: _________________________________________________ (7)
Item
Please tick who took decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Please tick who took decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Date of last contact
Item
Date of last contact:
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
text
C0805839 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section. (No, please give details within the Adverse Events section.)
Investigators signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed Investigator's name
Item
Printed Investigator's name:
text
C2826892 (UMLS CUI [1])