Concordance between eligibility criteria and relevant drug safety signals
| Criterion . | OR (95% CI) . | P value (controlling for phase) . | OR (95% CI) . | P value (controlling for phase and sponsor type) . |
|---|---|---|---|---|
| Renal function | 0.83 (0.43-1.60) | .5823 | 0.35 (0.15-0.81) | .0146 |
| ALT/AST | 1.22 (0.60-2.48) | .5758 | 0.87 (0.40-1.88) | .7144 |
| Total bilirubin | 1.49 (0.78-2.86) | .2312 | 0.88 (0.42-1.85) | .7388 |
| HIV | 0.80 (0.31-2.08) | .6449 | 0.70 (0.26-1.89) | .4800 |
| Hepatitis B | 1.10 (0.39-3.12) | .8512 | 1.01 (0.35-2.90) | .9826 |
| Hepatitis C | 1.01 (0.37-2.79) | .9789 | 0.94 (0.34-2.61) | .8995 |
| EF | 5.87 (1.82-18.94) | .0031 | 4.81 (1.44-16.04) | .0106 |
| QTc | 3.39 (1.29-8.89) | .0130 | 4.16 (1.45-11.87) | .0078 |
| Criterion . | OR (95% CI) . | P value (controlling for phase) . | OR (95% CI) . | P value (controlling for phase and sponsor type) . |
|---|---|---|---|---|
| Renal function | 0.83 (0.43-1.60) | .5823 | 0.35 (0.15-0.81) | .0146 |
| ALT/AST | 1.22 (0.60-2.48) | .5758 | 0.87 (0.40-1.88) | .7144 |
| Total bilirubin | 1.49 (0.78-2.86) | .2312 | 0.88 (0.42-1.85) | .7388 |
| HIV | 0.80 (0.31-2.08) | .6449 | 0.70 (0.26-1.89) | .4800 |
| Hepatitis B | 1.10 (0.39-3.12) | .8512 | 1.01 (0.35-2.90) | .9826 |
| Hepatitis C | 1.01 (0.37-2.79) | .9789 | 0.94 (0.34-2.61) | .8995 |
| EF | 5.87 (1.82-18.94) | .0031 | 4.81 (1.44-16.04) | .0106 |
| QTc | 3.39 (1.29-8.89) | .0130 | 4.16 (1.45-11.87) | .0078 |
Values in boldface are significant at P < .05.