Table 2.
Crude adverse event rates, and relative risk of adverse events
| Adverse event | Number of trials | Total number of patients | Number of patients in bismuth arms | Number of patients in comparison arms | Number of adverse events in bismuth arms (%) | Number of adverse events in comparison arms (%) | Relative risk of adverse events with bismuth versus comparison regimen (95% CI) |
| Any | 25 | 3180 | 1585 | 1595 | 431 (27.2) | 419 (26.3) | 1.01 (0.87-1.16) |
| Abdominal pain | 13 | 2439 | 1221 | 1218 | 63 (5.2) | 61 (5.0) | 1.06 (0.64-1.74) |
| Dark stools | 4 | 467 | 233 | 234 | 39 (16.7) | 5 (2.1) | 5.06 (1.59-16.12) |
| Diarrhoea | 22 | 3406 | 1761 | 1645 | 124 (7.0) | 113 (6.9) | 1.01 (0.72-1.42) |
| Dizziness | 8 | 1630 | 867 | 763 | 54 (6.2) | 49 (6.4) | 1.18 (0.81-1.72) |
| Headache | 14 | 2433 | 1276 | 1157 | 41 (3.2) | 28 (2.4) | 1.31 (0.81-2.11) |
| Metallic taste | 14 | 2475 | 1260 | 1215 | 124 (9.8) | 116 (9.6) | 1.02 (0.81-1.28) |
| Nausea and/or vomiting | 20 | 3417 | 1767 | 1650 | 111 (6.3) | 86 (5.2) | 1.16 (0.89-1.52) |
| Leading to withdrawal of therapy | 28 | 3951 | 2033 | 1918 | 33 (1.6) | 38 (2.0) | 0.86 (0.54-1.37) |