Table 2.
ICSRs | ROR (95% CI) | p Value |
---|---|---|
General disorders and administration site conditions | 1.14 (1.06–1.21) | <0.0001 |
Blood and lymphatic system disorders | 0.75 (0.70–0.80) | <0.0001 |
Musculoskeletal and connective tissue disorders | 1.21 (1.18–1.32) | <0.0001 |
Investigations | 1.01 (0.93–1.10) | 0.78 |
Abbreviations: ICSRs = Individual Case Safety Reports; ADRs = adverse drug reactions; SOCs = System Organ Classes; ROR = reporting odds ratio; CI = confidence interval.