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mGC or mGEJC - maintenance (M), avelumab based treatment , 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) 0.91 [0.74, 1.11]< 10%1 study (1/-)81.9 %NAnot evaluable crucial-
progression or deaths (PFS) 1.04 [0.85, 1.28]< 10%1 study (1/-)35.4 %NAnot evaluable important-
DCR 0.62 [0.43, 0.89]> 10%1 study (1/-)0.5 %NAnot evaluable non important-
objective responses (ORR) 0.91 [0.55, 1.51]> 10%1 study (1/-)35.7 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 1.25 [0.67, 2.33]< 10%1 study (1/-)24.1 %NAnot evaluable non important-
AE (grade 3-4) 0.98 [0.68, 1.40]< 10%1 study (1/-)55.1 %NAnot evaluable non important-
AE leading to death (grade 5) 1.22 [0.57, 2.59]< 10%1 study (1/-)30.3 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.43 [0.28, 0.64]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
SAE (any grade) 1.26 [0.86, 1.83]< 10%1 study (1/-)11.9 %NAnot evaluable non important-
STRAE (any grade) 0.79 [0.42, 1.50]< 10%1 study (1/-)76.3 %NAnot evaluable non important-
TRAE (any grade) 0.47 [0.31, 0.69]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.31 [0.19, 0.49]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.49 [0.02, 14.64]< 10%1 study (1/-)65.8 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.31 [0.18, 0.50]< 10%1 study (1/-)100.0 %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.



 

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