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gastric or gastroesophageal junction cancer (GC), 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) 0.93 [0.81, 1.06]< 10%2 studies (2/-)87.2 %some concernnot evaluable moderatecrucial-
progression or deaths (PFS) 1.56 [1.38, 1.78]< 10%2 studies (2/-)0.0 %some concernnot evaluable moderateimportant-
objective responses (ORR) 0.50 [0.17, 1.47]> 191%2 studies (2/-)10.6 %some concernnot evaluable moderatenon 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) 0.15 [0.08, 0.30]< 177%2 studies (2/-)100.0 %some concernnot evaluable moderatenon 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) 0.30 [0.03, 3.29]< 10%2 studies (2/-)83.5 %some concernnot evaluable moderatenon important-
Anaemia TRAE (grade 3-4) 0.23 [0.04, 1.25]< 183%2 studies (2/-)95.5 %some concernnot evaluable moderatenon 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-
Colitis TRAE (grade 3-4) 0.16 [0.01, 3.11]< 10%1 study (1/-)88.6 %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) 0.56 [0.03, 11.52]< 171%2 studies (2/-)64.6 %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) 0.26 [0.08, 0.83]< 11%2 studies (2/-)98.9 %some concernnot evaluable moderatenon 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) 0.22 [0.03, 1.54]< 168%2 studies (2/-)93.5 %some concernnot evaluable moderatenon 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) 1.41 [0.11, 18.47]< 10%2 studies (2/-)39.6 %some concernnot evaluable moderatenon important-
Infusion-related reactions TRAE (grade 3-4) 0.47 [0.02, 14.02]< 10%1 study (1/-)66.7 %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) 0.14 [0.02, 1.23]< 149%2 studies (2/-)96.1 %some concernnot evaluable moderatenon important-
Neutropenia TRAE (grade 3-4) 0.01 [0.00, 0.06]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon 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-
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) 0.19 [0.02, 2.03]< 13%2 studies (2/-)91.4 %some concernnot evaluable moderatenon important-
Pneumonitis TRAE (grade 3-4) 3.77 [0.17, 84.06]< 10%1 study (1/-)20.4 %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-
Severe skin reaction TRAE (grade 3-4) 1.88 [0.06, 56.28]< 10%1 study (1/-)36.0 %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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