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metastatic/advanced NSCLC (mNSCLC) - 1st line (L1), sintillimab plus SoC 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) 0.61 [0.40, 0.93]< 10%1 study (1/-)99.0 %NAnot evaluable crucial-
progression or deaths (PFS) 0.48 [0.36, 0.64]< 10%1 study (1/-)100.0 %NAnot evaluable important-
objective responses (ORR) 2.54 [1.63, 3.97]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 1.02 [0.03, 30.46]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
AE (grade 3-4) 1.13 [0.74, 1.73]< 10%1 study (1/-)29.1 %NAnot evaluable non important-
AE leading to death (grade 5) 0.31 [0.11, 0.90]< 10%1 study (1/-)98.4 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.70 [0.31, 1.55]< 10%1 study (1/-)81.1 %NAnot evaluable non important-
AE leading to treatment discontinuation (grade 3-4) 0.64 [0.26, 1.56]< 10%1 study (1/-)83.6 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Diarrhoea TRAE (grade 3-4) 0.49 [0.01, 24.91]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.49 [0.01, 24.91]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.49 [0.01, 24.91]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.49 [0.01, 24.91]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.49 [0.01, 24.91]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 0.98 [0.09, 10.96]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.49 [0.01, 24.91]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.16 [0.02, 1.56]< 10%1 study (1/-)94.1 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

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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