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. 2015 Nov 16;10(7):828–836. doi: 10.1093/ecco-jcc/jjv208

Table 1.

Baseline demographics and clinical characteristics

Placebo [N = 54] Budesonide foam QD [N = 55] Budesonide foam BID [N = 56] Total [N = 165]
Age [years], mean [SD] 39.9 [13.0] 44.7 [13.3] 40.8 [11.2] 41.8 [12.6]
Male sex, n [%] 31 [57.4] 32 [58.2] 26 [46.4] 89 [53.9]
Body weight [kg], mean [SD] 61.7 [10.3] 60.7 [13.7] 60.1 [11.5] 60.8 [11.9]
Current smoker, n [%] 3 [5.6] 1 [1.8] 5 [8.9] 9 [5.5]
Duration of disease [years], mean [SD] 3.5 [3.5] 5.7 [5.6] 5.8 [5.9] 5.0 [5.2]
Clinical course, n [%]
 First attack 8 [14.8] 6 [10.9] 9 [16.1] 23 [13.9]
 Relapsing/remitting 46 [85.2] 49 [89.1] 47 [83.9] 142 [86.1]
Duration of present active phase [days], mean [SD] 108.9 [202.4] 86.0 [131.3] 95.3 [140.4] 96.6 [160.0]
 <4 weeks, n [%] 22 [40.7] 27 [49.1] 27 [48.2] 76 [46.1]
 ≥4 weeks, n [%] 32 [59.3] 28 [50.9] 29 [51.8] 89 [53.9]
Extent of lesions, n [%]
 Proctitis 25 [46.3] 26 [47.3] 28 [50.0] 79 [47.9]
 Sigmoiditis 29 [53.7] 29 [52.7] 28 [50.0] 86 [52.1]
MMDAI, n [%]
 Score 3–5 27 [50.0] 26 [47.3] 25 [44.6] 78 [47.3]
 Score 6–8 27 [50.0] 29 [52.7] 31 [55.4] 87 [52.7]
Previous medication for UC — n [%]
 Oral 5-ASA 47[87.0] 48[87.3] 44[78.6] 139[84.2]
 5-ASA enema or suppository 21[38.9] 23[41.8] 25[44.6] 69[41.8]
Concomitant therapy for UC— n [%]
 Oral 5-ASA 47 [87.0] 48 [87.3] 43 [76.8] 138 [83.6]
 Oral salazosulfapyridine 0 [0.0] 0 [0.0] 1 [1.8] 1 [0.6]
 None 7 [13.0] 7 [12.7] 12 [21.4] 26 [15.8]

MMDAI, Modified Mayo Disease Activity Index; BID, twice a day administration; QD, once daily administration; SD, standard deviation, 5-ASA, 5-aminosalicylic acid; UC, ulcerative colitis.