Table 3.

Adverse Events (Safety Population).^*

Event	Oxytocin (N = 146)	Placebo (N = 144)
Any adverse event — no. of participants (%)	120 (82)	120 (83)
Maximum intensity of any adverse event in each participant — no. of participants (%)
Death	0	0
Life-threatening	0	1 (1)
Severe	7 (5)	10 (7)
Moderate	67 (46)	52 (36)
Mild	46 (32)	57 (40)
Adverse event considered to be related to oxytocin or placebo, according to intensity category — no. of events/total no. (%)
Severe	5/13 (38)	13/25 (52)
Moderate	76/171 (44)	68/172 (40)
Mild	154/301 (51)	158/313 (50)
Adverse event leading to withdrawal from trial — no. of participants (%)†	4 (3)	3 (2)
Serious adverse event — no. of participants (%)‡	2 (1)	1 (1)

^*The safety population included all the participants who received at least one dose of oxytocin or placebo. A list of specific adverse events is provided in Table S5.

^†In the oxytocin group, irritability occurred in two patients and aggression and sedation occurred in one patient each. In the placebo group, viral infection, gastrointestinal discomfort, and increased libido with impulsivity occurred in one patient each.

^‡In the oxytocin group, appendicitis and sedation leading to a motor vehicle accident occurred in one patient each. In the placebo group, a single patient had dysphoria and irritability, which were considered to be separate serious adverse events.