All line listings contain field names on the first row. These field names are mapped to convenient database table column names for better readability. This table contains the mapping of the fields to columns plus a description.
CSV field name
Database column name
EU Local Number
The identifier of the individual case safety repport (ICSR)
the value of this field is always "Spontanous"
EV Gateway Receipt Date
Date/time the report was issued
Primary Source Qualification
Can be "Healthcare Professional", "Non Healthcare Professional" or "Not Specified"
Primary Source Country for Regulatory Purposes
Can be "European Economic Area" "Non European Economic Area" or "Not Specified"
Patient Age Group
split in lower and upper values in months as this is the lowest resolution present f.i. for children aged 0 to 2 months. Calculating the lower and upper age value allows measuring withing groups as the age groups are sometimes shifted.
Patient Age Group (as per reporter)
All rows in the CSV files contained the value "Not specified" so we skipped it
Parent Child Report
Can be true or false
Can be "Female" or "Male"
Reaction List PT (Duration – Outcome - Seriousness Criteria)
Suspect/interacting Drug List (Drug Char - Indication PT - Action taken - [Duration - Dose - Route])
Concomitant/Not Administered Drug List (Drug Char - Indication PT - Action taken - [Duration - Dose - Route])
Skipped because it can be reconstructed from the local_number