Table 3.

Patients with suspected cases of adverse drug reactions by MedDRA Preferred Terms (safety analysis set, absolute and relative number of patients). In all cases, causality was assessed as “unlikely”, except for 1 case of diarrhea (“possible”).

	EPs 7630 syrup (n = 403)	EPs 7630 solution (n = 188)
Hepatic enzyme increased	2 (0.5%)	1 (0.5%)
Aspartate aminotransferase increased	1 (0.3%)	2 (1.1%)
Transaminase increased	–	1 (0.5%)
Diarrhea	1 (0.3%)	2 (1.1%)
Vomiting	–	1 (0.5%)
Upper abdominal pain	–	1 (0.5%)
Any potentially related events	4 (1.0%)	7 (3.7%)