Table 1.

Incidence densities (ID) for events, ranked in order of number of events in month 1 (where ID₁–ID₂ > 0).

Higher term description	n1	n2	ID1	ID2	ID1– ID2	CI min	CI max	na	IDa	Incidence risk (%)	No of ADRs
Dyspepsia	394	332	33.6	10.2	23.4	18.8	28.0	835	13.0	5.47	50
Nausea, vomiting	179	116	15.3	3.6	11.7	8.6	14.8	326	5.1	2.14	51
Diarrhoea	160	109	13.6	3.3	10.3	7.4	13.2	300	4.7	1.96	37
Pain abdomen	160	145	13.6	4.4	9.2	6.3	12.1	358	5.6	2.34	32
Oedema	86	79	7.3	2.4	4.9	2.8	7.1	198	3.1	1.30	7
Dizziness	78	54	6.6	1.7	5.0	3.0	7.0	152	2.4	1.00	25
Intolerance	69	24	5.9	0.7	5.2	3.3	7.0	99	1.5	0.65	4
Headache, migraine	69	66	5.9	2.0	3.9	1.9	5.8	161	2.5	1.05	13
Gastrointestinal unspecified	61	54	5.2	1.7	3.6	1.7	5.4	129	2.0	0.84	35
Malaise, lassitude	59	54	5.0	1.7	3.4	1.6	5.2	136	2.1	0.89	21
Pruritus	50	47	4.3	1.4	2.8	1.2	4.5	114	1.8	0.75	11
Rash	40	59	3.4	1.8	1.6	0.1	3.1	123	1.9	0.81	11
Dyspnoea	35	39	3.0	1.2	1.8	0.4	3.2	89	1.4	0.58	4
Constipation	28	27	2.4	0.8	1.6	0.3	2.8	70	1.1	0.46	2
Unspecified side-effects	27	18	2.3	0.6	1.8	0.6	2.9	51	0.8	0.33	47
Insomnia	24	19	2.0	0.6	1.5	0.3	2.6	50	0.8	0.33	6
Drowsiness, sedation	21	11	1.8	0.3	1.5	0.4	2.5	35	0.5	0.23	11

n₁Total number of reports of each event during the first month of treatment; n₂, total number of reports of each event during treatment in months 2–6; ID₁, incidence density for each event during the first month of treatment; ID₂, incidence density for each event during treatment months 2–6; ID₁–ID₂, arithmetic difference between ID₁ and ID₂; 99% CI, 99% confidence intervals for ID₁–ID₂; n_a, total number of reports of each event during the total treatment period; ID_a, incidence density for each event for the total treatment period; incidence risk (%) as proportion of events reported by study cohort (n = 15 268); ADR, adverse drug reaction.