Table 3.

Adverse Events among Women Who Received Medical Treatment for Early Pregnancy Loss.

Event	Mifepristone-Pretreatment Group (N = 149)	Misoprostol-Alone Group (N = 151)	Relative Risk or Incidence Rate Ratio (95% CI)*	P Value
Serious adverse events reported by participants
Total number (rate per 100 women†)	5 (3.4)	3 (2.0)	1.68 (0.40–7.05)	0.47
Bleeding resulting in blood transfusion — no. of participants (%)	3 (2.0)	1 (0.7)	3.04 (0.32–28.6)	0.31
Pelvic infection — no. of participants (%)‡	2 (1.3)	2 (1.3)	1.01 (0.15–7.01)	0.99
Adverse events reported by participants
Total no.	904	843
Mean no. per participant	6.1	5.6	1.09 (0.99–1.19)	0.08
Type of event — no. of participants (%)
Fatigue	118 (79.2)	115 (76.2)	1.04 (0.92–1.17)	0.53
Headache	88 (59.1)	72 (47.7)	1.24 (1.00–1.54)	0.05
Dizziness or lightheadedness	78 (52.3)	68 (45.0)	1.16 (0.92–1.47)	0.20
Chills	68 (45.6)	70 (46.4)	0.99 (0.77–1.26)	0.90
Nausea	56 (37.6)	56 (37.1)	1.01 (0.76–1.36)	0.93
Diarrhea	41 (27.5)	44 (29.1)	0.94 (0.66–1.35)	0.76
Vomiting	40 (26.8)	23 (15.2)	1.76 (1.11–2.79)	0.01
Severe cramping	20 (13.4)	21 (13.9)	0.97 (0.58–1.61)	0.90
Fever	10 (6.7)	9 (6.0)	1.12 (0.47–2.68)	0.79

^*The rates for the total number of serious adverse events and mean number of adverse events were compared with the use of incidence rate ratios, with adjustment for trial site. The percentages of women who had each type of adverse event were compared with the use of relative risks that were adjusted for trial site with the Mantel–Haenszel method.

^†The rate per 100 women is shown to account for the fact that a woman could have more than one event.

^‡Pelvic infection includes diagnoses of endometritis and septic abortion.