Ursodeoxycholic acid counteracts celecoxib in reduction of duodenal polyps in patients with familial adenomatous polyposis: a multicentre, randomized controlled trial

Table 2 Adverse events in patients with FAP treated with either celecoxib & ursodeoxycholic acid or celecoxib & placebo

		Treatment groups
CTCAE Category	Name adverse event	Group A n = 19	Group B n = 18
Auditory/Ear	Otitis, middle ear	1 (0/1/0)	0
Blood/Bone marrow	Anemia - hemoglobin	1 (1/0/0)	0
	Leukopenia	1 (0/1/0)	0
Cardiac arrhythmia	Palpitations	0	2 (2/0/0)
Constitutional symptoms	Fatique	2 (0/1/1)	1 (0/1/0)
	Insomnia	1 (0/0/1)	0
Dermatology/Skin	Hair loss - scalp	1 (1/0/0)	0
	Rash	1 (0/1/0)	1 (0/1/0)
Gastrointestinal	Constipation	2 (2/0/0)	2 (2/0/0)
	Diarrhea	2 (1/1/0)	2 (2/0/0)
	Heartburn/dyspepsia/nausea	4 (1/3/0)	2 (1/1/0)
	Ulcera - oral	0	1 (1/0/0)
	Ulcera - ileum/colon/rectum	1 (1/0/0)	0
Hepatobiliary/Pancreas	Pancreas irritation*	0	1 (0/1/0)
Infection	Infection - gastroenteritis	1 (0/1/0)	2 (0/2/0)
	Infection - dental-tooth	1 (0/1/0)	1 (0/1/0)
	Infection - skin	1 (0/1/0)	1 (0/1/0)
Lymphatics	Edema - lower limbs	2 (1/1/0)	0
Metabolic/Laboratory	Elevated AST, GGT	1 (1/0/0)	1 (1/0/0)
	Hypokalemia	1 (0/0/1)	0
Neurology	Dizzyness	1 (1/0/0)	0
	Mood alteration - depression	1 (0/0/1)	0
	Neuropathy - carpal tunnel syndrome	1 (0/1/0)	0
Pain	Abdominal	1 (0/0/1)	0
	Anal/perianal	4 (0/4/0)	1 (0/1/0)
	Joint	0	1 (0/1/0)
	Chest/thorax	0	1 (0/1/0)
Pulmonary/Upper respiratory	Dyspnea	0	2 (0/2/0)
	Nasal cavity/paranasal sinus reaction	0	2 (0/2/0)
Renal/Genitourinary	Lower urinary tract symptoms - prostatism	1 (0/1/0)	0
Secondary malignancy	Secondary malignancy - basalioma - nose	1 (0/0/1)	0
	Total n of reported AE	34 (10/18/6)**	24 (9/15/0)**
	Patients reporting ≥1 AE (n, %)	16 (84.2%)	14 (77.8%)

Number of specific adverse event reported during 6 month intervention in patients with FAP with either celecoxib & ursodeoxycholic acid (Group A) or celecoxib & placebo (Group B), is depicted as grade 1, 2, or 3, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 4 and 5 adverse events did not occur. * Adverse event related to pre-intervention duodenoscopy; no other adverse events related to duodenoscopy were reported; ** Distribution of number of adverse events grade 1, 2, or 3, was not significantly different between treatment groups (Fisher’s exact, p=0.114). CTCAE Common Terminology Criteria for Adverse Events, FAP familial adenomatous polyposis, AST aspartate aminotransferase, GGT gamma-glutamyl transpeptidase, AE Adverse Event.

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