Table 2.

Children with P vivax or mixed malaria infection reporting at least one serious adverse event occurring within 28 days of initiating primaquine (or equivalent time schedule in placebo and no primaquine groups), by age category and primaquine dose

	All (n=1797)	Age <5 years (n=293)	Age 5 to <15 years (n=1504)
Any serious adverse event	20 (1·1%)	2 (0·7%)	18 (1·2%)
No primaquine	3/508* (0·6%)	0/94	3/414 (0·7%)
Low daily dose	2/185† (1·1%)	0/29	2/156 (1·3%)
Intermediate daily dose	4/561‡ (0·7%)	1/89 (1·1%)	3/472 (0·6%)
High daily dose	11/543§ (2·0%)	1/81 (1·2%)	10/462 (2·2%)

Data are n (%) or n/N (%). A low daily dose is defined as about 0·25 mg/kg per day, intermediate daily dose as about 0·5 mg/kg per day, and a high daily dose as about 1 mg/kg per day. P vivax=Plasmodium vivax.

^*Serious adverse events and causality to primaquine were severe vomiting (unrelated; n=1), dengue fever (unrelated; n=1), and dry mouth and taste disorder (unrelated; n=1).

^†Serious adverse events and causality to primaquine were jaundice and haemoglobinuria (possibly related; n=1), and lethargy, tachycardia, and abdominal pain (possibly related; n=1).

^‡Serious adverse events and causality to primaquine were haemolysis (probably related; n=1), methaemoglobinaemia and scrub typhus (probably related; n=1), methaemoglobinaemia (probably related; n=1), and pneumonia and oesophagitis (possibly related; n=1).

^§Serious adverse events and causality to primaquine were haemolysis (possibly related; n=1), haemolysis (probably related; n=1), methaemoglobinaemia (definitely related; n=1), methaemolglobinaemia (probably related; n=3), vomiting (possibly related; n=1), dyspepsia (possibly related; n=1), diarrhoea (possibly related; n=1), vomiting (unrelated; n=1), and asthma (unrelated; n=1). Additional details on serious adverse events are provided in the appendix (pp 57–59).