4. EudraVigilance

Stakeholder Group II Healthcare Professionals and the Public

Access point:

·       Adrreports.eu portal

Content overview

·       Aggregated data outputs based on predefined queries

·       ICSR line listings (based on core ICSR data elements)

·       ICSR forms (for individual case review)

Section according to
ICH E2B(R3) ICSR Implementation Guide

Data element name

Explanation/
possible values

C.1 Identification of the Case Safety Report

Type of Report

“EudraVigilance Local Report Number”

classification of a report by sender (e.g., spontaneous report)

displayed as “EudraVigilance Local Report Number”

C.2.r Primary Source(s) of Information

Reporter’s Country Code

Qualification (reporter group)

Country code displayed as EEA or Non-EEA

Healthcare Professional (Physician, Pharmacist or Other HCP)

Non-Healthcare Professional (Lawyer, Consumer or Other non-HCP)

C.3 Information on Sender of Case Safety Report

Sender Type

Sender’s organisation

Displayed as e.g. "EEA Regulator" or “Regional Pharmacovigilance Centre”

C.4.r Literature Reference(s)

Literature Reference(s)

C.5 Study Identification

Study Registration Number

Study Name

Study Type Where Reaction(s) / Event(s) were Observed

D. Patient Characteristics

Patient Age Group (as per reporter)

Sex

Age group (mapped against “Age at Time of Onset of Reaction/Event”, based on the reported patient age or calculated based on difference between “Date of Birth” and “First Reaction Start Date”

Male/female/not specified

E.i Reaction(s)/event(s)

Reaction / Event (MedDRA code^E)

Results in Death

Life Threatening

Caused / Prolonged Hospitalisation

Disabling / Incapacitating

Congenital Anomaly / Birth Defect

Serious

Other Medically Important Condition (Non-Serious)

Suspected Reported Reaction (Preferred Term in MedDRA) (PT)

Reaction Group (System Organ Class in MedDRA) (SOC)

Any undesirable effect (suspected adverse reaction) reported by the reporter

e.g. Headache, Ear infection

e.g. Nervous system disorders

Duration of reaction / Event (number) Duration of Reaction / Event (unit)

Outcome of Reaction / Event at the Time of Last Observation

Recovered/resolved

Recovering/resolving

Not recovered/not resolved

Recovered/resolved with sequelae

Fatal

Unknown

Not specified

G.k Drug(s) information

Characterisation of Drug Role

Pharmaceutical Product Identifier (PhPID)

Medicinal Product Name as Reported by the Primary Source^F

Substance / Specified Substance Name^F

G.k.4.r Dosage and Relevant Information

Dose (number

Dose (unit))

Number of Units in the Interval

Definition of the Time Interval Unit Duration of Drug Administration (number)

Duration of Drug Administration unit)

 Pharmaceutical Dose Form Term ID

Route of Administration Term ID

Parent Route of Administration Term ID

G.k.7.r Indication for Use in Case

Indication (MedDRA code)

Action(s) Taken with Drug

G.k.9.i Drug-reaction(s) / Event(s) Matrix

Did Reaction Recur on Re- administration?

Additional Information on Drug (coded