Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial

Table 3 ICON8 updated safety analysis—total events

	Standard	Research 1	Research 2	Total
Carboplatin	3-weekly	3-weekly	Weekly
Paclitaxel	3-weekly	Weekly	Weekly
AE dataset only
Number of events	15,767	18,690	16,592	51,019
Proportion of patients with a grade 3+ event	42%	61%	52%
Difference in grade 3+ events (95% CI)	n/a	19% (13%, 25%)	9% (3%, 15%)
Combined dataset
Additional SAE elements	300	343	443	1086
Number of events	16,067	19,033	17,005	52,105
Proportion of patients with a grade 3+ event	47%	65%	59%
Difference in grade 3+ events (95% CI)	n/a	18% (12 to 24%)	12% (6 to 18%)

ISSN: 1745-6215