GVP – Module IX Addendum I: Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

IX.Add.I.

IX. Add I.1. Introduction

IX.Add I.2. Statistical methods

IX.Add I.2.2. Increased ICSR reporting frequency

IX. Add I.3.1. Designated medical events

IX.Add I.3.2. Serious events

IX.Add I.4. Methods aimed at specific patient populations

IX. Add I.4.1. Paediatric population

IX. Add I.4.2. Geriatric population

IX. Add I.5. Methods aimed at specific circumstances of medicines use