Table 5.

Frequency of adverse events

Adverse events observed in the double-blind period	Lansoprazole (n = 183)	Gefarnate (n = 181)	P value
All adverse events	154 (84.2) [121.2]	125 (69.1) [127.7]	0.0006
Causal relationship to drug not deniable	28 (15.3) [22.0]	28 (15.5) [28.6]	0.9643
Leading to treatment discontinuations	29 (15.8)	23 (12.7)	0.3920
Serious adverse events	29 (15.8) [22.8]	17 (9.4) [17.4]	0.0638
Causal relationship to drug not deniable	2 (1.1) [–]	1 (0.6) [–]	0.5685
Deaths	2 (1.1)	2 (1.1)	0.9918
Adverse events reported in at least 3% of total in each group
Nasopharyngitis	57 (31.1) [44.9]	42 (23.2) [42.9]	0.0769
Diarrhea	19 (10.4) [15.0]	–	<0.0001
Fall	12 (6.6) [9.4]	10 (5.5) [10.2]	0.6793
Constipation	10 (5.5) [7.9]	10 (5.5) [10.2]	0.9798
Eczema	10 (5.5) [7.9]	–	0.0014
Osteoarthritis	8 (4.4) [6.3]	6 (3.3) [6.1]	0.6001
Reflux esophagitis	–	12 (6.6) [12.3]	0.0003
Hypertension	7 (3.8) [5.5]	8 (4.4) [8.2]	0.7753
Contact dermatitis	–	7 (3.9) [7.2]	0.0072
Nausea	6 (3.3) [4.7]	–	0.0140
Foot tinea	6 (3.3) [4.7]	–	0.0140
Pneumonia	6 (3.3) [4.7]	–	0.0140
Back pain	6 (3.3) [4.7]	–	0.0140
Elevated blood creatine phosphokinase levels	6 (3.3) [4.7]	8 (4.4) [8.2]	0.5713
Rheumatoid arthritis	–	6 (3.3) [6.1]	0.0130

Table data are numbers (%) of patients in whom an event occurred at least one time during the trial. Numbers in brackets for adverse events are incidence rates in person-years