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mUC - M - PDL1 positive, avelumab alone , 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) 0.56 [0.40, 0.79]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
deaths (OS) (extension) 0.69 [0.52, 0.91]< 10%1 study (1/-)99.6 %NAnot evaluable important-
PFS (extension) 0.46 [0.36, 0.59]< 10%1 study (1/-)100.0 %NAnot evaluable important-
progression or deaths (PFS) 0.56 [0.43, 0.73]< 10%1 study (1/-)100.0 %NAnot evaluable important-
DCR 2.03 [1.31, 3.16]> 10%1 study (1/-)99.9 %NAnot evaluable non important-
objective responses (ORR) 12.70 [2.11, 76.32]> 10%1 study (1/-)99.7 %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.