Table 6.

Harms analysis populations in 69 trials that presented harms analyses

	Number (%a)
Harms analysis population specifically defined in methods	26 (38)
Defined harms analysis population	Based on actual treatment received (that is, including all patients who had received at least one administration of treatment)	18
	Intention to treat	5
	All who started allocated treatment	2
	All who completed allocated treatment	1
Harms analysis population not specifically defined in methods	43 (62)
Inferred harms analysis population	Stated ‘safety population’ without further definition	1
	Apparently analysed as per efficacy outcomes	33
	Intention to treat definition	31
	Per protocol definition	2
	No details given of harms or benefit analysis population	9

^aThe number of trials with harms analyses presented (69) is used as the denominator for %.