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mBC - TNBC - L1 - all population, pembrolizumab 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) 0.89 [0.76, 1.05]< 10%1 study (1/-)92.1 %NAnot evaluable crucial-
progression or deaths (PFS) 0.82 [0.69, 0.97]< 10%1 study (1/-)99.0 %NAnot evaluable important-
objective responses (ORR) 0.24 [0.17, 0.33]> 10%1 study (1/-)0.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 1.25 [0.41, 3.87]< 10%1 study (1/-)34.7 %NAnot evaluable non important-
AE (grade 3-4) 1.26 [0.91, 1.76]< 10%1 study (1/-)8.4 %NAnot evaluable non important-
TRAE (any grade) 1.35 [0.68, 2.70]< 10%1 study (1/-)19.7 %NAnot evaluable non important-
TRAE (grade 3-4) 1.06 [0.78, 1.44]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
TRAE leading to death (grade 5) 2.00 [0.09, 44.58]< 10%1 study (1/-)33.2 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Alopecia TRAE (grade 3-4) 0.83 [0.20, 3.51]< 10%1 study (1/-)59.9 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 1.15 [0.77, 1.71]< 10%1 study (1/-)25.2 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 2.00 [0.09, 44.58]< 10%1 study (1/-)33.2 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 1.15 [0.47, 2.82]< 10%1 study (1/-)38.3 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.00 [0.03, 29.90]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 2.00 [0.09, 44.58]< 10%1 study (1/-)33.2 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 1.29 [0.67, 2.48]< 10%1 study (1/-)22.7 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.83 [0.58, 1.19]< 10%1 study (1/-)84.3 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 1.13 [0.34, 3.69]< 10%1 study (1/-)42.2 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.99 [0.73, 1.36]< 10%1 study (1/-)52.1 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 6.05 [0.34, 108.78]< 10%1 study (1/-)11.3 %NAnot evaluable non important-
Severe skin reaction TRAE (grade 3-4) 10.16 [0.59, 174.64]< 10%1 study (1/-)5.7 %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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