Periodic Safety Update Report #3 (Pfizer)

"6.3 Cumulative and Interval summary Tabulations from Post-Marketing Data Sources

Appendix 2.2 provides a cumulative and interval summary tabulation of adverse drug reactions by PT [preferred term] from post-marketing sources...

6.3.1.1. General Overview of the Safety Database - All Cases ...

General Overview - All Cases

A total of 508,351 case reports ... containing 1,597,673 events fulfilled criteria for inclusion in this PSUR [periodic safety update report] reporting period..."

"6.3.1.1.2. General Overview of the Safety Database - Post-Authorization Data

During the reporting period, in the PM [post-marketing] dataset the number of female subjects was 2.2 times the number of male subjects (63.8% vs 29.4%)...

Adverse Event Data

A total of 1,596,793 AEs (of which 439,443 were serious and 1,158,240 non-serious) were reported in 507,683 PM cases.

The MedDRA SOCs containing the greatest number of events (≥2%) were General disorders and administration site conditions (459,731), Nervous system disorders (204,185), Musculoskeletal and connective tissue disorders (148,849), Injury, poisoning and procedural complications (130,333), Infections and infestations (82,131), Gastrointestinal disorders (81,816), Reproductive system and breast disorders (77,917), Skin and subcutaneous tissue disorders (62,405), Respiratory thoracic and mediastinal disorders (56,663), Cardiac disorders (54,208), Surgical and medical procedures (52,531), and Blood and lymphatic system disorders (38,366)."