Definition

The total of all safety data from first approval through the current data lock point, providing historical context.

Example

Since launch in 2010, cumulative data includes 25,000 adverse event reports, with estimated cumulative exposure of 5 million patient-years.

Regulatory source

ICH E2C(R2)

Common mistakes

Not maintaining accurate cumulative counts, leading to inconsistencies between PSURs.

Inspector question

How do you maintain cumulative safety data? How do you reconcile numbers across reports?

Related terms