Table 3.

ADRs occurring in ≥1% of patients by system organ class and preferred term

System organ class	Safety analysis set
	(n = 1365)
Preferred term	Patients, n (%)	EAIRa per year (95% CI)
Patients with at least one ADRb	531 (38.9)	0.461 (0.422–0.502)
GI disorders	436 (31.9)	0.355 (0.322–0.390)
Diarrhoea	194 (14.2)	0.133 (0.115–0.153)
Faeces discoloured	128 (9.4)	0.090 (0.075–0.107)
Abnormal faeces	48 (3.5)	0.032 (0.023–0.042)
Constipation	40 (2.9)	0.026 (0.018–0.035)
Abdominal pain	38 (2.8)	0.024 (0.017–0.034)
Nausea	36 (2.6)	0.023 (0.016–0.032)
Faeces soft	20 (1.5)	0.013 (0.008–0.020)
Vomiting	17 (1.2)	0.011 (0.006–0.017)
Dyspepsia	16 (1.2)	0.010 (0.006–0.017)
Injury, poisoning and procedural complications	59 (4.3)	0.039 (0.030–0.050)
Off-label use	29 (2.1)	0.019 (0.013–0.027)
General disorders and administration site conditions	56 (4.1)	0.037 (0.028–0.048)
Drug ineffective	26 (1.9)	0.017 (0.011–0.025)
Treatment non-compliance	15 (1.1)	0.010 (0.005–0.016)
Product issues	24 (1.8)	0.015 (0.010–0.023)
Product taste abnormal	23 (1.7)	0.015 (0.009–0.022)

^aThe EAIR is defined as the number of patients with a specific event divided by the total follow-up time for all patients in years.

^bAll ADRs were coded based on MedDRA version 22.0 terminology into system organ class and preferred terms.

MedDRA: Medical Dictionary for Regulatory Activities.