Table 3.

Treatment-Emergent Adverse Event Profile Of The Trial Population (Safety Set)

	Patients 2 to ≤6 Years			Patients 6 to ≤12 Years			Patients 12 To ≤18 Years			Entire patient population
Placebo N=12	Tapentadol N=23	Overall N=35	Placebo N=15	Tapentadol N=32	Overall N=47	Placebo N=25	Tapentadol N=53	Overall N=78	Placebo N=52	Tapentadol N=108	Overall N=160
Any TEAE	5 (41.7%)	9 (39.1%)	14 (40%)	6 (40%)	15 (46.9%)	21 (44.7%)	15 (60%)	38 (71.7%)	53 (67.9%)	26 (50%)	62 (57.4%)	88 (55%)
Any serious TEAE	0	0	0	0	1 (3.1%)	1 (2.1%)	0	1 (1.9%)	1 (1.3%)	0	2 (1.9%)	2 (1.3%)
Any TEAE related to trial medicationa	1 (8.3%)	2 (8.7%)	3 (8.6%)	3 (20%)	10 (31.3%)	13 (27.7%)	7 (28%)	17 (32.1%)	24 (30.8%)	11 (21.2%)	29 (26.9%)	40 (25%)
Any TEAE causing discontinuation of treatment	0	1 (4.3%)	1 (2.9%)	0	2 (6.3%)	2 (4.3%)	2 (8%)	7 (13.2%)	9 (11.5%)	2 (3.8%)	10 (9.3%)	12 (7.5%)
Any TEAE in ≥5% of patients
Vomiting	0	4 (17.4%)	4 (11.4%)	1 (6.7%)	8 (25%)	9 (19.1%)	5 (20%)	13 (24.5%)	18 (23.1%)	6 (11.5%)	25 (23.1%)	31 (19.4%)
Nausea	0	2 (8.7%)	2 (5.7%)	0	2 (6.3%)	2 (4.3%)	4 (16%)	12 (22.6%)	16 (20.5%)	4 (7.7%)	16 (14.8%)	20 (12.5%)
Constipation	0	2 (8.7%)	2 (5.7%)	0	2 (6.3%)	2 (4.3%)	6 (24%)	7 (13.2%)	13 (16.7%)	6 (11.5%)	11 (10.2%)	17 (10.6%)
Pyrexia	0	2 (8.7%)	2 (5.7%)	1 (6.7%)	1 (3.1%)	2 (4.3%)	0	7 (13.2%)	7 (9%)	1 (1.9%)	10 (9.3%)	11 (6.9%)
Somnolence	0	1 (4.3%)	1 (2.9%)	0	1 (3.1%)	1 (2.1%)	2 (8%)	4 (3.9%)	6 (7.7%)	2 (3.8%)	6 (5.6%)	8 (5%)
Pruritus	1 (8.3%)	1 (4.3%)	2 (5.7%)	1 (6.7%)	1 (3.1%)	2 (4.3%)	1 (4%)	2 (3.8%)	3 (3.8%)	3 (5.8%)	4 (3.7%)	7 (4.4%)

Notes: Data are number of patients (%). ^aAt least possibly related in the opinion of the investigator.

Abbreviation: TEAE, treatment-emergent adverse event.