Multicenter, randomized study to optimize bowel preparation for colon capsule endoscopy

Table 6 Adverse events: Frequency and severity by subject

Adverse event	Study regimen, n = 62	Control regimen, n = 59	P value
Subjects with ≥ 1, n (%) [95%CI]	12 (19.4) [10.4; 31.4]	2 (3.4) [0.4; 11.7]	0.0062
Occurring in > 2% of subjects, n (%) [95%CI]
Headache	2 (3.2) [0.4; 11.2]	1 (1.7) [0.0; 9.1]
Nausea	4 (6.5) [1.8; 15.7]	2 (3.4) [0.4; 11.7]
Vomiting	2 (3.2) [0.2; 38.5]	0 (0) [0.0; 77.6]
Maximum AE severity1, n (%) [95%CI]
Mild	6 (50) [21.1; 78.9]	2 (100) [22.4; 100.0]
Moderate	5 (41.7) [15.2; 72.3]	0 (0) [0.0; 77.6]	0.308
Severe	1 (8.3) [0.2; 38.5]	0 (0) [0.0; 77.6]

¹Subjects were counted once according to maximum severity; 2_nd Statistically significant.