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mGC or mGEJC - L1 - PDL1 positive, anti-PD-(L)1 versus placebo plus SoC, 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) 0.80 [0.67, 0.96]< 18%2 studies (2/-)99.1 %lownot evaluable highcrucial-
progression or deaths (PFS) 0.93 [0.72, 1.20]< 150%2 studies (2/-)71.2 %lownot evaluable highimportant-
objective responses (ORR) 0.97 [0.34, 2.76]> 188%2 studies (2/-)47.7 %lownot evaluable highnon important-

safety endpoints 00

AE (any grade) 0.68 [0.19, 2.43]< 10%1 study (1/-)72.4 %NAnot evaluable non important-
AE (grade 3-4) 1.16 [0.79, 1.71]< 10%1 study (1/-)22.2 %NAnot evaluable non important-
AE leading to death (grade 5) 1.64 [0.39, 6.94]< 10%1 study (1/-)25.1 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 1.73 [1.13, 2.66]< 10%1 study (1/-)0.6 %NAnot evaluable non important-
TRAE (any grade) 1.40 [0.70, 2.80]< 10%1 study (1/-)17.2 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Alopecia TRAE (grade 3-4) 0.98 [0.02, 49.38]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.81 [0.48, 1.37]< 10%1 study (1/-)77.9 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.87 [0.35, 2.19]< 10%1 study (1/-)61.3 %NAnot evaluable non important-
Blood creatinine increased TRAE (grade 3-4) 0.49 [0.02, 14.58]< 10%1 study (1/-)65.9 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.98 [0.02, 49.38]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.61 [0.28, 1.34]< 10%1 study (1/-)88.9 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.83 [0.38, 1.83]< 10%1 study (1/-)67.9 %NAnot evaluable non important-
Dizziness TRAE (grade 3-4) 0.98 [0.06, 15.69]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Dry skin TRAE (grade 3-4) 0.98 [0.02, 49.38]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Dysgeusia TRAE (grade 3-4) 0.98 [0.02, 49.38]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 1.35 [0.66, 2.76]< 10%1 study (1/-)20.4 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.96 [0.07, 58.57]< 10%1 study (1/-)35.2 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 5.98 [0.71, 50.01]< 10%1 study (1/-)5.1 %NAnot evaluable non important-
Mucosal inflammation TRAE (grade 3-4) 0.70 [0.32, 1.56]< 10%1 study (1/-)80.7 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 1.03 [0.53, 2.02]< 10%1 study (1/-)46.3 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.87 [0.58, 1.30]< 10%1 study (1/-)74.9 %NAnot evaluable non important-
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) 1.49 [0.60, 3.70]< 10%1 study (1/-)19.7 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 1.97 [0.36, 10.84]< 10%1 study (1/-)21.9 %NAnot evaluable non important-
Peripheral sensory neuropathy TRAE (grade 3-4) 5.91 [0.29, 118.71]< 10%1 study (1/-)12.5 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.98 [0.02, 49.38]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 1.96 [0.07, 58.57]< 10%1 study (1/-)35.2 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 1.20 [0.49, 2.95]< 10%1 study (1/-)34.5 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 1.14 [0.38, 3.45]< 10%1 study (1/-)40.7 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.83 [0.38, 1.83]< 10%1 study (1/-)67.9 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 1.96 [0.18, 21.75]< 10%1 study (1/-)29.3 %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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