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breast cancer (BC), lapatinib plus capecitabine , meta-analysis of study results

Outcome Relative effect 95%CI LoD Trt. better when I2 k (RCT/OBS) Bayesian probability Overall ROB Publication bias Degree of certainty Endpoint importance Published MA

efficacy endpoints 00

deaths (OS) 1.11 [0.84, 1.45]< 180%4 studies (4/-)23.1 %some concernnot evaluable moderatecrucial-
progression or deaths (PFS) 1.44 [1.28, 1.63]< 10%3 studies (3/-)0.0 %some concernnot evaluable moderateimportant-
objective responses (ORR) 0.96 [0.44, 2.10]> 182%3 studies (3/-)45.9 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE leading to treatment discontinuation (any grade) 1.15 [0.59, 2.25]< 10%1 study (1/-)33.7 %NAnot evaluable non important-

LoD: level of statistical demonstration: Statistically conclusive: statistically significant with a strict control of overall risk of type 1 error (statistically demonstrated), does not take into account the risk of bias; suggested: nominally statistically significant but without a strict control of overall risk of type 1 error; inconclusive: not nominally statistically significant; safety concerns;
Bayesian probability: Bayesian posterior probability of treatment effect (computed with a noninformative prior); ROB: risk of bias; k: number of studies; published MA: number of published meta-analysis on the same topic; degree of certainty adapted from GRADE. Trt. better when: indicates when the relative treatment effect shows that the studied treatment is better than control.