Table 9.

Adverse event monitoring and reporting

Study ID	Sample size	Clinical symptoms monitoring	Biochemistry	Haematological	Electrocardiogram	Additional comments on adverse events
Adam 2002 SDN	41	Not reported	Not reported	Not reported	Not reported	"Neurological deficits were not observed in any patient during the follow‐up period"
Aguwa 2010 NGA	90	Not reported	Not reported	Not reported	Not reported	None
Hien 1996 VNM	560	Clinical assessment every 4 hours for the first 24 hours and 6 hourly afterwards	Blood glucose, lactate and cytokine levels measured 4, 8, 12 and 24 hours after admission	Full blood count on admission	Pre‐treatment and 12 hours after initiation of treatment on Day 0, 4 hours after last dose and at discharge	None
Huda 2003 IND	46	Lumbar puncture Chest x‐ray on day 0	Blood Glucose, Renal Function Test, Liver Function Test and Serum Electrolyte on Days 0 and 3	Full Blood Count on Days 0 and 3	Day 0	"No serious side effects of either of the drugs were observed in our study...... Closer and more frequent monitoring and larger sample size would have probably revealed more subtle adverse drug effects."
Karbwang 1992 THA	26	Clinical evaluation daily for at least 7 days Lumbar puncture Chest x‐ray on day 0	Biochemistry on Days 0, 2, 4 and 7	Full Blood Count on Days 0, 2, 4 and 7	On admission for all patients; then once daily and every six hours for quinine and artemether patients respectively	"The side effects in the quinine group were dizziness and vertigo. No side effects were detected with artemether".
Karbwang 1995 THA	102	Clinical evaluation on admission and twice daily for at least 7 days Lumbar puncture Chest x‐ray on day 0	Biochemistry on Days 0, 2, 4 and 7	FBC on Days 0, 2, 4 and 7	On admission for all patients; then once daily and every six hours for quinine and artemether patients respectively	QTc prolongation and tinnitus were the major adverse events in Quinine arm. Mild transient pain at injection site for approximately 15 mins after artemether treatment.
Minta 2005 MLI	67	Clinical examination daily on Days 1 to7, and 14	Blood glucose on Days 1, 2, 3, 5, 7 and 14 Urea and Serum Electrolyte, transaminases, phosphatases on Days 1, 3, 5, 7 and 14	FBC on Days 1, 3, 5, 7 and 14	Once daily on Days 1, 3, 5, 7 and 14	None
Murphy 1996 KEN	160	Clinical assessment on admission, then at six, then 12 hour intervals till discharge	Blood glucose, urea, electrolytes, blood gases and when clinically indicated	FBC on Day 0 and when clinically indicated Blood cultures on Day 0	On admission and at 6, 24, 30, 48 and 54 hours	None
Ojuawo 1998 NGA	37	Clinical assessment on Day 0	Urea and electrolyte Blood sugar and liver function test on Day 0	FBC on Day 0	None	None
Olumese 1999 NGA	103	Clinical assessments on Days 0, 3, 7, 14, 28	Blood glucose, Urea and creatinine, electrolytes on Days 0, 3, 7, 14, 28	WBC count on Days 0, 3, 7, 14, 28	None	"No adverse reactions to the two drugs were recorded during the study".
Osonuga 2009 NGA	32	Clinical examination on Days 0 to 7 and 14	None	None	None	None
Phu 2010 VNM	370	Clinical examination on admission Chest x‐ray on admission Lumbar puncture	Blood urea nitrogen, serum creatinine, aspartate aminotransferase, alanine transaminase, plasma lactate	Full blood count on admission	None	None
Satti 2002 SDN	77	Clinical evaluation on admission and every six hours on Days 0 to 4, and then once daily on Days 14, 21 and 28	Blood glucose, serum creatinine, serum aspartate, aminotransferase on Day 0	WBC, Haemoglobin on Days 0 and 3	None	None
Seaton 1998 PNG	33	Chest X‐ray on admission	Renal and Liver function tests on admission, Days 3 and 7	Full Blood Count on Days 0, 3 and 7	None	None
Taylor 1998 MWI	183	CSF collected on admission	Blood glucose, Blood pH, on D0 (every four hours for the first 24 hours	Haematocrit every eight hours Full Blood Count, urea and electrolytes on Days 0, 3, 7 and 28	On admission, 6, 48,54 and 96 hours	"Of the initial 127 patients on whom serial electrocardiographic tracings were made, more patients in the quinine group showed prolongation of the corrected QT intervals after treatment, but the differences were not statistically or clinically significant." "There were no significant differences between the two treatment groups in terms of adverse effects associated with antimalarial treatment (i.e. new signs and symptoms which develop within seven days of the start of treatment)."
van Hensbroek 1996 GMB	576	Clinical examination on Day 0 Lumbar puncture on admission	Blood glucose on admission, after 4hours and 12 hours	PCV, Haemoglobin, Blood culture on Day 0	None	None
Vinh 1997 VNM	124	Clinical examination on admission	Blood glucose, serum creatinine, serum bilirubin on admission	Full blood count on admission	None	None
Walker 1993 NGA	54	Clinical examination twice daily Spinal taps	Urea and Electrolyte, on days 3, 7, 14, 28	PCV on days 3, 7, 14, 28	On admission, at 4 and 6 hours	None