Otilonium bromide in irritable bowel syndrome: A dose-ranging randomized double-blind placebo-controlled trial

Table 3 Summary of all adverse events reported by treatment (safety population)

Treatment	Adverse event	Duration (d)	Intensity1	Serious	Outcome	Relation
Placebo	Flu/fever	12	1	No	Resolved	Not related
Placebo	Severe headache	3	2	No	Resolved	Not related
Placebo	Headache	14	2	No	Resolved	Probably related2
20 mg	Headache	5	1	No	Resolved	Possible related2
20 mg	Xerostomia	6	2	No	Resolved	Unlikely related2
20 mg	High fever	1	1	No	Resolved	Not related
20 mg	Pharyngitis	7	2	No	Resolved	Not related
20 mg	Pneumonia	17	2	No	Resolved	Not related
40 mg	Flu/fever	4	1	No	Resolved	Not related
40 mg	Asthma exacerbation	1	1	No	Resolved	Not related
40 mg	GI infection	6	2	No	Resolved	Not related
80 mg	Cystitis	19	1	No	Resolved	Not related
80 mg	Migraine attack1 nausea	1	1	No	Resolved	Not related
80 mg	Nausea	4	1	No	Resolved	Possible related2

¹Intensity was rated on a scale of 1-3 (1 = mild, 2 = moderate and 3 = severe);

²Adverse events subsequently confirmed as being related to treatment. OB: Otilonium bromide; GI: Gastrointestinal.