Table 4. Proportion of patients with adverse events in all randomized patients (N = 782).

	Intention to treat analysis*
	Paracetamol (N = 261)	Ibuprofen (N = 258)	Combined (N = 263)	P value
Extra analgesic given in ED	26	31	33
Within the ED phase
Diarrhoea	0 (0%)	0 (0%)	0 (0.0%)	1.0
Dizziness	4 (1.5%)	1 (0.4%)	3 (1.1%)	0.4
GI discomfort	1 (0.4%)	3 (1.2%)	4 (1.5%)	0.4
Headache	0 (0%)	1 (0.4%)	3 (1.1%)	0.2
Nausea/ Vomit	1 (0.4%)	1 (0.4%)	1 (0.4%)	1.0
Rash	3 (1.1%)	3 (1.2%)	0 (0.0%)	0.2
Sleepiness	6 (2.3%)	12 (4.7%)	6 (2.3%)	0.2
Others	2 (0.8%)	0 (0%)	0 (0.0%)	0.1
Within 28 days
Diarrhoea	2 (0.8%)	1 (0.4%)	1 (0.4%)	0.8
Dizziness	20 (7.7%)	14 (5.4%)	28 (10.6%)	0.1
GI discomfort	31 (11.9%)	41 (15.9%)	36 (13.7%)	0.4
Headache	13 (5.0%)	13 (5.0%)	18 (6.8%)	0.6
Nausea/ Vomit	11 (4.2%)	11 (4.3%)	10 (3.8%)	1.0
Rash	7 (2.7%)	11 (4.3%)	7 (2.7%)	0.5
Sleepiness	28 (10.7%)	22 (8.5%)	21 (8.0%)	0.5
Others	10 (3.8%)	11 (4.3%)	9 (3.4%)	0.9
Number of adverse events within 28 days
0	183 (70.1%)	178 (69.0%)	180 (68.4%)	0.7
1	47 (16.9%)	51 (19.4%)	50 (19.0%)
2	22(9.2%)	15 (6.2%)	22 (7.6%)
3	6 (2.3%)	13 (3.9%)	8 (3.0%)
>3	3 (1.5%)	1 (1.6%)	3 (1.9%)

* The proportions of patients experiencing adverse events were compared between groups using chi-square test.

ED = Emergency Department