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mGC or mGEJC - 2nd Line (L2), pembrolizumab 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) 0.94 [0.79, 1.12]< 10%1 study (1/-)75.6 %NAnot evaluable crucial-
progression or deaths (PFS) 1.49 [1.25, 1.77]< 10%1 study (1/-)0.0 %NAnot evaluable important-
objective responses (ORR) 0.88 [0.53, 1.45]> 10%1 study (1/-)30.5 %NAnot evaluable non important-

safety endpoints 00

TRAE (any grade) 0.21 [0.14, 0.31]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.31 [0.21, 0.47]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 2.84 [0.29, 27.42]< 10%1 study (1/-)18.6 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.55 [0.24, 1.28]< 10%1 study (1/-)91.8 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Alopecia TRAE (grade 3-4) 0.16 [0.01, 3.11]< 10%1 study (1/-)88.6 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.54 [0.21, 1.38]< 10%1 study (1/-)90.1 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.16 [0.01, 3.11]< 10%1 study (1/-)88.6 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 3.77 [0.17, 84.06]< 10%1 study (1/-)20.4 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 0.94 [0.02, 47.47]< 10%1 study (1/-)51.2 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.94 [0.06, 15.08]< 10%1 study (1/-)51.8 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.49 [0.19, 1.26]< 10%1 study (1/-)93.1 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 7.60 [0.40, 144.43]< 10%1 study (1/-)9.1 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.94 [0.02, 47.47]< 10%1 study (1/-)51.2 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 3.77 [0.17, 84.06]< 10%1 study (1/-)20.4 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.94 [0.02, 47.47]< 10%1 study (1/-)51.2 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 0.47 [0.02, 14.02]< 10%1 study (1/-)66.7 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.47 [0.04, 5.19]< 10%1 study (1/-)73.1 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.02 [0.00, 0.25]< 10%1 study (1/-)99.8 %NAnot evaluable non important-
Pancreatitis TRAE (grade 3-4) 0.47 [0.02, 14.02]< 10%1 study (1/-)66.7 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 0.08 [0.00, 1.38]< 10%1 study (1/-)95.8 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 3.77 [0.17, 84.06]< 10%1 study (1/-)20.4 %NAnot evaluable non important-
Severe skin reaction TRAE (grade 3-4) 1.88 [0.06, 56.28]< 10%1 study (1/-)36.0 %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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