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mGC or mGEJC - 1st line (L1), 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) 0.91 [0.75, 1.11]< 10%1 study (1/-)82.4 %NAnot evaluable crucial-
progression or deaths (PFS) 1.66 [1.37, 2.01]< 10%1 study (1/-)0.0 %NAnot evaluable important-
objective responses (ORR) 0.29 [0.19, 0.45]> 10%1 study (1/-)0.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.34 [0.11, 1.06]< 10%1 study (1/-)96.9 %NAnot evaluable non important-
AE (grade 3-4) 0.09 [0.06, 0.14]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
AE leading to death (grade 5) 0.96 [0.19, 4.80]< 10%1 study (1/-)52.0 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.19 [0.09, 0.38]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (any grade) 0.11 [0.06, 0.18]< 10%1 study (1/-)100.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Alopecia TRAE (grade 3-4) 0.96 [0.02, 48.60]< 10%1 study (1/-)50.8 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.10 [0.03, 0.27]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.09 [0.01, 0.73]< 10%1 study (1/-)98.8 %NAnot evaluable non important-
Blood creatinine increased TRAE (grade 3-4) 0.96 [0.06, 15.44]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.96 [0.02, 48.60]< 10%1 study (1/-)50.8 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.16 [0.05, 0.55]< 10%1 study (1/-)99.8 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.20 [0.06, 0.69]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
Dizziness TRAE (grade 3-4) 0.48 [0.02, 14.35]< 10%1 study (1/-)66.2 %NAnot evaluable non important-
Dry skin TRAE (grade 3-4) 0.96 [0.02, 48.60]< 10%1 study (1/-)50.8 %NAnot evaluable non important-
Dysgeusia TRAE (grade 3-4) 0.96 [0.02, 48.60]< 10%1 study (1/-)50.8 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.06 [0.01, 0.50]< 10%1 study (1/-)99.6 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.92 [0.06, 57.64]< 10%1 study (1/-)35.5 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.48 [0.02, 14.35]< 10%1 study (1/-)66.2 %NAnot evaluable non important-
Mucosal inflammation TRAE (grade 3-4) 0.03 [0.00, 0.51]< 10%1 study (1/-)99.2 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.05 [0.01, 0.37]< 10%1 study (1/-)99.8 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.01 [0.00, 0.08]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) 0.06 [0.00, 1.02]< 10%1 study (1/-)97.3 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 0.24 [0.01, 5.32]< 10%1 study (1/-)81.4 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.96 [0.02, 48.60]< 10%1 study (1/-)50.8 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.96 [0.02, 48.60]< 10%1 study (1/-)50.8 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 0.05 [0.00, 0.89]< 10%1 study (1/-)97.8 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.08 [0.00, 1.41]< 10%1 study (1/-)95.6 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.03 [0.00, 0.55]< 10%1 study (1/-)99.1 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 0.48 [0.02, 14.35]< 10%1 study (1/-)66.2 %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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