A novel duodenal-release formulation of caraway oil and L-menthol is a safe, effective and well tolerated therapy for functional dyspepsia

Table 2 10 Most commonly reported Adverse Events associated with COLM-SST*

System organ class	MedDRA term	Cumulative AEs			Individual AEs
System organ class	MedDRA term	Months 1–12	Months 1–24	Months 1–36	Months 1–12	Months 13–24	Months 25–36
Gastrointestinal disorders	Dyspepsia	9	10	22	9	1	12
Gastrointestinal disorders	Diarrhoea	4	7	13	4	3	6
Nervous system disorders	Headache	5	9	11	5	4	2
Gastrointestinal disorders	Nausea	3	6	11	3	3	5
Gastrointestinal disorders	Abdominal distension	4	7	10	4	3	3
Gastrointestinal disorders	Abdominal pain upper	3	6	9	3	3	3
Gastrointestinal disorders	Throat irritation	4	6	9	4	2	3
Gastrointestinal disorders	Abdominal discomfort	2	7	8	2	5	1
Gastrointestinal disorders	Abdominal pain	4	7	8	4	3	1
Skin and subcutaneous tissue disorders	Pruritus	1	4	6	1	3	2
Total AEs		75	148	205	75	73	57

*Total accumulative sample size (FDgard® users) at 24 months was estimated at 558,300; Estimated total users at 36 months was > than 1,000,000. Adverse Events listed by system organ class and further divided into MedDRA Term

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