Table 6.
Percentage of Serious Adverse Drug Reactions per Study Group
| Mean | SD | UCI | LCI | Min | Max | |
|---|---|---|---|---|---|---|
| Group A (Extensive Metabolizers) | ||||||
| Neutropenia G4 | 5.72% | 1.08% | 7.98% | 3.63% | 2.47% | 9.73% |
| Neutropenia G5 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Leukopenia G4 | 0.57% | 0.33% | 1.33% | 0.00% | 0.00% | 2.08% |
| Leukopenia G5 | 0.19% | 0.19% | 0.57% | 0.00% | 0.00% | 1.52% |
| Stomatitis G4 | 0.57% | 0.32% | 1.33% | 0.00% | 0.00% | 1.89% |
| Stomatitis G5 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Infection G4 | 0.57% | 0.33% | 1.33% | 0.00% | 0.00% | 1.89% |
| Infection G5 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Diarrhea G4 | 1.70% | 0.56% | 2.84% | 0.76% | 0.00% | 4.36% |
| Diarrhea G5 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Cardiovascular G4 | 0.57% | 0.33% | 1.33% | 0.00% | 0.00% | 2.27% |
| Cardiovascular G5 | 0.19% | 0.19% | 0.57% | 0.00% | 0.00% | 1.14% |
| Thrombocytopenia G4 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Thrombocytopenia G5 | 0.19% | 0.19% | 0.57% | 0.00% | 0.00% | 1.52% |
| Hepatic G4 | 0.56% | 0.42% | 1.52% | 0.00% | 0.00% | 3.03% |
| Acute_pancreatitis G4 | 0.19% | 0.19% | 0.57% | 0.00% | 0.00% | 1.14% |
| Hand_and_foot_syndrome G4 | 0.38% | 0.26% | 0.95% | 0.00% | 0.00% | 1.52% |
| Febrile neutropenia G4 | 0.75% | 0.38% | 1.52% | 0.19% | 0.00% | 2.46% |
| Hematochezia G4 | 0.19% | 0.19% | 0.57% | 0.00% | 0.00% | 1.14% |
| Neurological G4 | 0.76% | 0.38% | 1.52% | 0.19% | 0.00% | 2.27% |
| Nausea & Vomiting G4 | 0.19% | 0.19% | 0.57% | 0.00% | 0.00% | 1.14% |
| Group B (Intermediate and Poor Metabolizers) | ||||||
| Neutropenia G4 | 7.18% | 4.02% | 16.67% | 0.00% | 0.00% | 26.19% |
| Neutropenia G5 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Leukopenia G4 | 2.33% | 2.36% | 7.14% | 0.00% | 0.00% | 14.29% |
| Leukopenia G5 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Stomatitis G4 | 2.39% | 2.42% | 7.50% | 0.00% | 0.00% | 14.29% |
| Stomatitis G5 | 2.38% | 2.33% | 7.14% | 0.00% | 0.00% | 14.29% |
| Infection G4 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Infection G5 | 2.38% | 2.33% | 7.14% | 0.00% | 0.00% | 14.29% |
| Diarrhea G4 | 9.47% | 4.53% | 19.05% | 2.38% | 0.00% | 28.57% |
| Diarrhea G5 | 2.38% | 2.33% | 7.14% | 0.00% | 0.00% | 14.29% |
| Cardiovascular G4 | 2.40% | 2.31% | 7.14% | 0.00% | 0.00% | 16.67% |
| Cardiovascular G5 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Thrombocytopenia G4 | 2.38% | 2.37% | 7.14% | 0.00% | 0.00% | 14.29% |
| Thrombocytopenia G5 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Hepatic G4 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Acute_pancreatitis G4 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Hand_and_foot_syndrome G4 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Febrile neutropenia G4 | 7.10% | 4.01% | 16.67% | 0.00% | 0.00% | 21.43% |
| Hematochezia G4 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Neurological G4 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Nausea & Vomiting G4 | 2.35% | 2.33% | 7.14% | 0.00% | 0.00% | 14.29% |
| Differences (Group B – Group A) | ||||||
| Neutropenia G4 | 1.46% | 4.17% | 10.48% | −5.68% | −9.51% | 21.45% |
| Neutropenia G5 | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Leukopenia G4 | 1.76% | 2.39% | 6.95% | −1.14% | −2.08% | 13.72% |
| Leukopenia G5 | −0.19% | 0.19% | 0.00% | −0.57% | −1.52% | 0.00% |
| Stomatitis G4 | 1.82% | 2.45% | 7.13% | −1.14% | −1.89% | 13.91% |
| Stomatitis G5 | 2.38% | 2.33% | 7.14% | 0.00% | 0.00% | 14.29% |
| Infection G4 | −0.57% | 0.33% | 0.00% | −1.33% | −1.89% | 0.00% |
| Infection G5 | 2.38% | 2.33% | 7.14% | 0.00% | 0.00% | 14.29% |
| Diarrhea G4 | 7.76% | 4.56% | 17.72% | 0.11% | −3.22% | 27.62% |
| Diarrhea G5 | 2.38% | 2.33% | 7.14% | 0.00% | 0.00% | 14.29% |
| Cardiovascular G4 | 1.83% | 2.34% | 6.95% | −1.14% | −2.27% | 16.10% |
| Cardiovascular G5 | −0.19% | 0.19% | 0.00% | −0.57% | −1.14% | 0.00% |
| Thrombocytopenia G4 | 2.38% | 2.37% | 7.14% | 0.00% | 0.00% | 14.29% |
| Thrombocytopenia G5 | −0.19% | 0.19% | 0.00% | −0.57% | −1.52% | 0.00% |
| Hepatic G4 | −0.56% | 0.42% | 0.00% | −1.52% | −3.03% | 0.00% |
| Acute_pancreatitis G4 | −0.19% | 0.19% | 0.00% | −0.57% | −1.14% | 0.00% |
| Hand_and_foot_syndrome G4 | −0.38% | 0.26% | 0.00% | −0.95% | −1.52% | 0.00% |
| Febrile neutropenia G4 | 6.34% | 4.03% | 15.53% | −0.76% | −2.08% | 21.24% |
| Hematochezia G4 | −0.19% | 0.19% | 0.00% | −0.57% | −1.14% | 0.00% |
| Neurological G4 | −0.76% | 0.38% | −0.19% | −1.52% | −2.27% | 0.00% |
| Nausea & Vomiting G4 | 2.17% | 2.33% | 7.14% | −0.57% | −1.14% | 14.29% |
Abbreviations: SD, standard deviation; LCI, lower confidence interval; UCI, upper confidence interval; G, grade. Results were based on 5,000 non-parametric bootstrap experiments.