Table 3.
High-grade toxicity |
Treatment-related mortality |
|||
---|---|---|---|---|
N | OR (95% CI) P value |
N | OR (95% CI) P value |
|
Overall P-value |
76 | 2.42 (1.98–2.97) <0.001 |
87 | 1.33 (1.15–1.53) <0.001 |
Class of experimental drug addedc Targeted small molecule inhibitor Targeted monoclonal antibody Immunotherapy Hormonal Not classified |
41 19 8 5 3 |
3.14 (2.49–3.97) p < .001 1.81 (1.24–2.64) p = .002 3.04 (1.76–5.28) p < .001 1.62 (0.85–3.08) p = .14 1.08 (0.43–2.72) p = .86 |
47 18 10 6 6 |
1.49 (1.19–1.87) p < .001 1.81 (1.33–2.46) p < .001 1.67 (1.13–2.45) p = .01 2.18 (1.43–3.32) p < .001 0.53 (0.26–1.08) p = .08 |
Phase of the Study Phase II Phase III |
46 30 |
2.45 (1.82–3.31) p < .0001 2.40 (1.80–3.19) p < .0001 |
52 35 |
1.25 (0.93–1.67) p = .13 1.72 (1.31–2.25) p = .003 |
aSingle agents are the reference point for all statistics. The final model included the following variables: High-Grade Toxicity (experimental drug class and linear toxicity rate in single arm); Treatment-related mortality (experimental drug class and linear treatment mortality rate in single arm);
bEstimated ORs in each model are valid after accounting for a linear dependence on the appropriate rate in the single arm. Model chosen using forward selection with entry p-value 0.10
cClass of experimental drug added to the backbone drug.
Abbreviations: N, number of randomized comparisons included; OR, odds ratio.