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mGC or mGEJC - 2nd Line (L2), avelumab based treatment versus chemotherapy, 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) 1.10 [0.88, 1.37]< 10%1 study (1/-)19.9 %NAnot evaluable crucial-
progression or deaths (PFS) 1.73 [1.38, 2.17]< 10%1 study (1/-)0.0 %NAnot evaluable important-
DCR 0.37 [0.23, 0.60]> 10%1 study (1/-)0.0 %NAnot evaluable non important-
objective responses (ORR) 0.49 [0.15, 1.66]> 10%1 study (1/-)12.7 %NAnot evaluable non important-

safety endpoints 00

TRAE (any grade) 0.34 [0.22, 0.52]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.22 [0.12, 0.40]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.48 [0.02, 14.39]< 10%1 study (1/-)66.2 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.74 [0.27, 2.03]< 10%1 study (1/-)72.2 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Alopecia TRAE (grade 3-4) 0.96 [0.02, 48.74]< 10%1 study (1/-)50.8 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.04 [0.00, 0.71]< 10%1 study (1/-)98.5 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.19 [0.02, 1.63]< 10%1 study (1/-)93.4 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.12 [0.01, 2.25]< 10%1 study (1/-)92.0 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.16 [0.02, 1.31]< 10%1 study (1/-)95.6 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.48 [0.04, 5.32]< 10%1 study (1/-)72.4 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.08 [0.00, 1.40]< 10%1 study (1/-)95.7 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 1.29 [0.28, 5.84]< 10%1 study (1/-)37.1 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.72 [0.16, 3.25]< 10%1 study (1/-)66.7 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 0.48 [0.04, 5.32]< 10%1 study (1/-)72.4 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 1.93 [0.06, 57.86]< 10%1 study (1/-)35.5 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.24 [0.01, 5.32]< 10%1 study (1/-)81.4 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.02 [0.00, 0.30]< 10%1 study (1/-)99.7 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.24 [0.01, 5.32]< 10%1 study (1/-)81.4 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 0.07 [0.00, 1.17]< 10%1 study (1/-)96.6 %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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