Statistical methods for the analysis of adverse event data in randomised controlled trials: a scoping review and taxonomy

Table 1 Summary level classifications

	Taxonomy of methods
	Visual Articles N = 8 [Methods N = 20]	Hypothesis testing Articles N = 11 [Methods N = 16]	Estimation Articles N = 15 [Methods N = 24]	Decision making probabilities Articles N = 10 [Methods N = 13]
Classification	n (%)	n (%)	n (%)	n (%)
Type of event
Prespecified	0 (0) [0 (0)]	5 (55.6) [7 (58.3)]	0 (0) [0 (0)]	4 (44.4) [5 (41.7)]
Emerging	8 (22.9) [20 (32.8)]	6 (17.1) [9 (14.8)]	15 (42.9) [24 (39.3)]	6 (17.1) [8 (13.1)]
Time of analysis
(Group) sequential	0 (0) [0 (0)]	5 (50.0) [6 (50.0)]	0 (0) [0 (0)]	5 (50.0) [6 (50.0)]
Final/one-analysis	8 (23.5) [20 (32.8)]	6 (17.6) [10 (16.4)]	15 (44.1) [24 (37.5)]	5 (14.7) [7 (11.5)]

ISSN: 1471-2288