Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting

Table 2 Patient characteristics, type, timing and outcomes of serious adverse events (SAEs) reported during 1^st September 2007 to 31^st March 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.
^a Report was initially misplaced at the health facility and not made available to safety coordinator on time
^b Skin 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

ISSN: 1475-2875