Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda

Table 3 Expected and unexpected SAE and AEs

	Expected	Unexpected
SAE	Victimisation (violence against the trial participant or nuclear family)	Death of the trial participant due to suicide
	IPV (violence against family members by participant, or violence against participant by family member)	Death of the trial participant due to other causes
	Suicide attempt	Hospital admission of trial participant due to a psychiatric problem
	Stigmatisation	Hospital admission of trial participant due to other causes
	Serious lack of food
AE	Clinical deterioration of the participant
AE	Emotional distress caused by a trial procedure (either by the outcome assessment or the intervention delivery)

ISSN: 1745-6215