pdf   xlsx method abbreviations

la/mBC - HR-positive - 2nd line (L2), ribociclib plus fulvestrant , 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) 0.72 [0.57, 0.91]< 10%1 study (1/-)99.6 %NAnot evaluable crucial-
deaths (OS) (extension) 0.73 [0.59, 0.90]< 10%1 study (1/-)99.9 %NAnot evaluable important-
progression or deaths (PFS) 0.59 [0.48, 0.73]< 10%1 study (1/-)100.0 %NAnot evaluable important-
CBR 1.40 [1.01, 1.94]> 10%1 study (1/-)97.8 %NAnot evaluable non important-
objective responses (ORR) 1.75 [1.22, 2.52]> 10%1 study (1/-)99.9 %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.