Table 2.

Infections during Gammaplex® therapy

Number with SABIs	n	0
Number who recorded an infection during study	n (%)	40 (80·0%)
*Presumed infectious episodes per subject per year	Mean (s.d.)	3·28 (3·024)
	Median	3·07
	Range	0–14·9
	n	50
*Presumed infectious episodes per subject per year	None	10 (20·0%)
	> 0–< 3	13 (26·0%)
	3–< 5	16 (32·0%)
	5–< 10	9 (18·0%)
	≥ 10	2 (4·0%)
Sinus infections (subjects)	n (%)	19 (38·0%)
Overall upper respiratory tract infections (subjects)	n (%)	22 (44·0%)
Lower respiratory tract infections (subjects)	n (%)	10 (20·0%)
Urinary tract infections (subjects)	n (%)	6 (12·0%)
Gastrointestinal infections (subjects)	n (%)	9 (18·0%)
Other infections (subjects)	n (%)	19 (38·0%)

SABIs (serious, acute, bacterial infections), defined as bacterial pneumonia, bacteraemia or sepsis, osteomyelitis/septic arthritis, visceral abscess or bacterial meningitis in accordance with regulatory guidance and definitions [6]. ‘Other’ infections were those recorded for four subjects or fewer each.

^*If the patient recorded a possible infection on their diary card for any day, an infection was presumed whether or not it was confirmed by a health care professional, so the number of ‘presumed infectious episodes’ is a worst case for real infections. s.d.: standard deviation.