Data Value
Due to urgent private reason visit was postponed in agreement with investigator
Acc. to CTP 3.0 section 'trial design' not necessary
Visit 2 Day 2 will be postponed to day 3, Subject is unable to come into Unit due to Adverse Event
Due to logistical reason measurements at timepoints 1h, 3h and 6h after vaccination were performed out of the given timeframe (+/- 15 min.)
Due to private reason of the subject Visit 7 was not performed
due to logistic reason assessment was performed later
due to logistic reason phone call was performed earlier.
Due to logistic reason phone call was performed earlier
Subject had lost his "take-home given Paracetamol tablets", \n so instead he took Novaminsulfon
Telephone call earlier due to logistic reason
By mistake time was missing on ICF Version 6.0, dated on 26 JUN 2020 for this Subject.
Subject left the site earlier than planned
done by mistake, cause Visit 5 was scheduled and performed for day 28, so no entries were at site by subject itself
Body temperature measured right after vitals signs, time entered (12:30 h) by mistake. Correct time is unknown
call was too late due to volunteers problems with its mobile phone
Previous subject (0261) was dosed in two parts, only 1st vaccination time of this subject was regarded.
subject couldn't wait any longer to give urine.
due to emergency call of the checking physician
done by mistake, cause Visit 5 was scheduled and performed for day 27, so no entries were at site by subject itself
The test person returned from a corona endangered area 4 days ago