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Total number of reports and mean number of adverse events per report submitted in ICH-E2B(R3)
| Type of report | No. of reports in ICH-E2B(R3) format | Non-serious adverse reactions per report (mean) | Serious adverse reactions per report (mean) |
|---|---|---|---|
| Only serious | 65,869 | Not applicable | 2.8 |
| Serious and non-serious | 16,416 | 2.5 | 2.8 |
| Only non-serious | 118,264 | 2.4 | Not applicable |
ICH International Council for Harmonisation
