Table 5.

Incidence of adverse events based on pooled data – number (%) of patients and 95% confidence intervals.

System group	Type	EPs 7630 (n = 417)	Placebo (n = 416)	Risk difference
Gastrointestinal complaints	All events	26 (6·24%) [4·29%; 8·98%]	19 (4·57%) [2·94%; 7·02%]	1·67% [-1·46%; 4·86%]
	Potentially related events	25 (6·00%) [4·09%; 8·70%]	19 (4·57%) [2·94%; 7·02%]	1·43% [-1·68%; 4·58%]
Hypersensitivity reactions	All events	5 (1·20%) [0·51%; 2·78%]	3 (0·72%) [0·25%; 2·10%]	0·48% [-1·06%; 2·12%]
	Potentially related events	3 (0·72%) [0·24%; 2·09%]	2 (0·48%) [0·13%; 1·74%]	0·24% [-1·10%; 1·66%]
Epistaxis	All events	11 (2·64%) [1·48%; 4·66%]	6 (1·44%) [0·66%; 3·11%]	1·20% [-0·84%; 3·36%]
	Potentially related events	9 (2·16%) [1·14%; 4·05%]	4 (0·96%) [0·37%; 2·45%]	1·20% [-0·60%; 3·18%]
Gingival bleeding	All events	–	–	–
	Potentially related events	–	–	–
Liver associated events	All events	1 (0·24%) [0·04%; 1·35%]	1 (0·24%) [0·04%; 1·35%]	-0·00% [-1·13%; 1·12%]
	Potentially related events	1 (0·24%) [0·04%; 1·35%]	0 (0·00%) [0·00%; 0·91%]	0·24% [-0·70%; 1·35%]
All system groupsa	All events	66 (15·83%) [12·64%; 19·64%]	44 (10·58%) [7·97%; 13·90%]	5·25% [0·64%; 9·87%]
	All potentially related events	39 (9·35%) [6·92%; 12·53%]	25 (6·01%) [4·10%; 8·72%]	3·34% [-0·30%; 7·05%]

^aAlso includes events from system groups not shown in this table.