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. 2021 Mar 2;21:95. doi: 10.1186/s12876-021-01680-1

Table 3.

Adverse events and compliancea

Events 7-day STT 10-day BQT P value
(n = 164) (n = 160)
Adverse events, no. (%)
 Taste alteration 47 (28.7) 7 (4.4) < 0.001
 Nausea 14 (8.5) 38 (23.8) < 0.001
 Vomiting 0 (0) 10 (6.3) 0.001
 Diarrhea 25 (15.2) 28 (17.5) 0.583
 Abdominal discomfort 25 (15.2) 35 (21.9) 0.124
 Skin rash or urticaria 2 (1.2) 6 (3.8) 0.170
 Dizziness 9 (5.5) 15 (9.4) 0.182
 Headache 5 (3.0) 19 (11.9) 0.002
 Insomnia 5 (3.0) 2 (1.3) 0.448
 Dyspepsia 17 (10.4) 33 (20.6) 0.011
 General weakness 3 (1.8) 13 (8.1) 0.009
 Dyspnea 1 (0.6) 1 (0.6)  > 0.999
 Anorexia 0 (0) 9 (5.6) 0.002
 Dry mouth 5 (3.0) 2 (1.3) 0.448
 Chest discomfort 0 (0) 2 (1.3) 0.243
Any adverse event,b no. (%) 94 (57.3) 108 (67.5) 0.059
Compliance with the study drugs, no. (%) < 0.001
 Participants who took ≥ 80% of study drugs 145 (88.4) 117 (73.1)
 Participants who took < 80% of study drugs 19 (11.6) 43 (26.9)
 Participants with low compliance due to adverse events,c no. (%) 15 (9.1) 37 (23.1) 0.001

STT, proton-pump inhibitor-clarithromycin containing standard triple therapy; BQT, bismuth-containing quadruple therapy

aThis analysis was performed in the safety population, which included all participants who underwent randomization and received at least one dose allocated treatment. Thirteen participants in the 7-day PPI-clarithromycin containing triple therapy group and fifteen in the 10-day bismuth-containing quadruple therapy group were excluded in this analysis

bThere was no participant who had any serious adverse events including death, life-threatening events, hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and medically important event or reaction

cLow compliance was defined when participant took less than 80% of the study drugs