4. Safety analysis (secondary endpoint)
No treatment-related death or serious adverse events (grade 4) was observed during the study (Table 3). Among 114 patients using LNG-IUS with or without MA, no positive bacilli culturing result on LNG-IUS was found. LNG-IUS group achieved less weight gain (median, 0.0 kg; 95%CI, -1.0-1.3, P <0.001) compared with MA group (median, 5.0 kg; 95%CI, 2.3-8.1) or MA+LNG-IUS group (median, 5.0 kg; 95%CI, 3.2-7.8) (Fig.S1). Fewer patients in the LNG-IUS group experienced increased nocturnal urine, night sweats, insomnia, or edema face compared with the other two groups. MA group experienced similar adverse effects as MA+LNG-IUS group. Vaginal hemorrhage occurred more often in the MA+ LNG-IUS group than in the MA group (46.3% vs. 19.0%; P=0.002).