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mGC or mGEJC - 2nd Line (L2), anti-PD-(L)1 versus paclitaxel, 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) 1.00 [0.86, 1.16]< 116%2 studies (2/-)49.2 %some concernnot evaluable moderatecrucial-
progression or deaths (PFS) 1.58 [1.37, 1.82]< 15%2 studies (2/-)0.0 %some concernnot evaluable moderateimportant-
DCR 0.37 [0.23, 0.60]> 10%1 study (1/-)0.0 %NAnot evaluable non important-
objective responses (ORR) 0.81 [0.51, 1.28]> 10%2 studies (2/-)18.3 %some concernnot evaluable moderatenon important-

safety endpoints 00

TRAE (any grade) 0.26 [0.17, 0.42]< 157%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
TRAE (grade 3-4) 0.28 [0.20, 0.39]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
TRAE leading to death (grade 5) 1.64 [0.25, 10.83]< 10%2 studies (2/-)30.5 %some concernnot evaluable moderatenon important-
TRAE leading to discontinuation (any grade) 0.62 [0.32, 1.19]< 10%2 studies (2/-)92.6 %some concernnot evaluable moderatenon important-

TRAE (grade 3-4) endpoints 00

Alopecia TRAE (grade 3-4) 0.30 [0.03, 3.29]< 10%2 studies (2/-)83.5 %some concernnot evaluable moderatenon important-
Anaemia TRAE (grade 3-4) 0.21 [0.02, 2.39]< 165%2 studies (2/-)89.3 %some concernnot evaluable moderatenon important-
Asthenia TRAE (grade 3-4) 0.19 [0.02, 1.63]< 10%1 study (1/-)93.4 %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) 0.64 [0.02, 19.22]< 160%2 studies (2/-)59.9 %some concernnot evaluable moderatenon 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) 0.30 [0.06, 1.66]< 11%2 studies (2/-)91.4 %some concernnot evaluable moderatenon important-
Fatigue TRAE (grade 3-4) 0.49 [0.21, 1.17]< 10%2 studies (2/-)94.5 %some concernnot evaluable moderatenon important-
Febrile neutropenia TRAE (grade 3-4) 0.08 [0.00, 1.40]< 10%1 study (1/-)95.7 %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-
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) 0.95 [0.09, 10.52]< 10%2 studies (2/-)51.6 %some concernnot evaluable moderatenon important-
Nausea TRAE (grade 3-4) 0.36 [0.05, 2.43]< 10%2 studies (2/-)85.1 %some concernnot evaluable moderatenon important-
Neutropenia TRAE (grade 3-4) 0.02 [0.00, 0.12]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon 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-
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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