Table 3.

Adverse events among patients by SAM gel and control arm

Active Arm
Causality with the device	Severity	Patient ID	AE description	Number of entries
Not related	MILD	88, 146, 5	Abdominal pain	6
		272	Borreliosis after the Tick Bite	1
		88	Headache	1
		151	Heartburn	1
		146	Mild kidney problems	1
		88	Muscle pain	1
		76, 144	Nasopharyngitis	3
		88	Ovarian pain	1
		151	Swelling of the lower limbs	1
	Moderate	128	Appendectomy, phlegmone	1
		235	Blocked cervical spin	1
		146, 235	Headache	4
		85, 88	High fever	2
		151, 235	Worsening of atopic eczema, perioral dermatis	2
	Severe	145	Cystitis	1
		197*	Vaginal mycosis	1
Unlikely	Moderate	244	Herpes	1
		152	Tonsilitis	1
Total not related or unlikely	Number of patients	14	Total entries of AE	30
Possible/not known	Mild	26, 67	Cramps and tingling in the lower abdomen	4
		26, 62	Mild burning of the vagina	1
	Moderate	67	Abdominal pain	2
		67	Weak menstrual bleeding	1
		197*	Vaginal mycosis	1
	Severe	67	Severe menstrual bleeding	1
Probable	Moderate	62	Burning of the vagina	1
		62	Bloody discharge	1
Total possible/not known or probable	Number of patients	4	Total entries of AE	12
Total	Number of patients	17	Total entries of AE	42
Control arm
Not related	Moderate	124	Tonsilitis	1

*Patient with ID 197 had 2 entries for vaginal mycosis with different allocation by the doctor to causality with the device