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Table 2
Patient characteristics, type, timing and outcomes of serious adverse events (SAEs) reported during 1^stSeptember 2007 to 31^stMarch 2010.
Sex	Age (years)	SAE^a	Interval between event and recording	Outcome	Level of reporting

Female	37	Severe headache & vomiting	1 days	Recovered	II
Female	12	Dyspnoea & vomiting	1 day	Recovered	II
Male	2	Twitching	1 days	Recovered	II
Female	4	Severe vomiting	4 days	Recovered	II
Female	2	Generalized itching/rash^b	>60 days ^a	Recovered	II
Female	1	Respiratory distress	3 days	Died; not classified as suspected in Novartis safety database	III
Female	4	Convulsion	9 days	Died; not classified as suspected in Novartis safety database	II
Female	46	Dyspnoea	1 day	Recovered	II
Male	38	Generalized rash^b	7 days	Recovered	II
Female	47	Generalized rash^b	1 day	Recovered	II
Male	13	Dyspnoea & swollen eyelids	1 day	Recovered	II
Male	7 months	Skin rashes	20 days	Recovered	I
Female	17	Paraplegia	>60 days	Recovered	I
Female	5	Joint stiffness	>60 days	Recovered	I
Male	10	Dizziness & headache	30 days	Recovered	I
Female	32	Skin rashes & amnesia	>60 days	Recovered	I
Female	11	Skin rashes	60 days	Recovered	I
Male	7	Skin rashes	60 days	Recovered	I
Female	47	Skin Rashes	10 days	Recovered	II
Female	34 weeks (gestational age)	Stillbirth	>60 days	Stillbirth; not classified as suspected in Novartis safety database	II

All events were recorded following AL treatment and were classified as SAEs by presenting with any or all of the following: (a) fatal or life-threatening (b) prolonging hospitalization (c) resulting in persistent or significant disability/incapacity (d) may jeopardize the subject or (e) may require medical or surgical intervention to prevent one of the previous outcomes. ^aReport was initially misplaced at the health facility and not made available to safety coordinator on time ^bSkin depigmentation for an extended period, which was considered to constitute significant incapacity Level of reporting: Level I, IHDSS; Level II, health facilities; Level III, patient satisfaction/adherence survey
Kabanywanyi et al. Malaria Journal 2010 9:205 doi:10.1186/1475-2875-9-205

Table 2