Oral antibiotic prophylaxis for infection in patients with vascular anomalies receiving sirolimus treatment: a multicenter retrospective study

Table 2 Serious infection reported during the initial 12 months of treatment

Safety outcomes^a	Non-TMP-SMZ group n = 112	TMP-SMZ group n = 195	P values	OR (95% CI)
Percentage of patients with at least one serious infection, No. (%)^b	12 (10.7)	23 (11.8)	0.774	0.897 (0.428–1.881)^d
Serious infection, No. (%)
Upper respiratory infection	7 (6.3)	14 (7.2)	0.756	0.862 (0.337–2.203)^d
Pneumonia	5 (4.5)	7 (3.6)	0.703	1.255 (0.389–4.051)^d
Cutaneous infection^c	2 (1.8)	3 (1.5)	1.000	1.164 (0.191–7.071)^e
Gastroenteritis	1 (0.9)	2 (1.0)	1.000	0.869 (0.078–9.697)^e
Urinary tract infection	0 (0)	2 (1.0)	0.535	1.010 (0.996–1.025)^e
Lymph gland infection	1 (0.9)	0 (0)	0.365	0.991 (0.974–1.009)^e
Total	16	28	0.818^f	N/A

TMP-SMZ Trimethoprim-sulfamethoxazole, N/A Data not available
^aAdverse events were assessed with the Common Terminology Criteria for Adverse Events, version 4.0. A serious infection was defined as any of the grade ≥ 3 infections
^bOne patient may have had more than one serious infection
^cCutaneous infection included cellulitis, subcutaneous abscess and worsening skin ulceration
^dThe values were calculated using a chi-square test
^eThe values were calculated with Fisher’s exact test
^fP value was calculated with nonparametric Mann–Whitney U test

ISSN: 1750-1172