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Table 2 Patient characteristics, type, timing and outcomes of serious adverse events (SAEs) reported during 1st September 2007 to 31st March 2010.

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

Sex Age (years) SAEa 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/rashb >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 rashb 7 days Recovered II
Female 47 Generalized rashb 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
  1. 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.
  2. a Report was initially misplaced at the health facility and not made available to safety coordinator on time
  3. 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