Table 3.
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