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mUC - L2 - PDL1 positive, atezolizumab based treatment versus Standard of Care (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) 0.87 [0.72, 1.06]< 10%1 study (1/-)91.9 %NAnot evaluable crucial-
progression or deaths (PFS) 0.86 [0.53, 1.39]< 10%1 study (1/-)73.6 %NAnot evaluable important-
DOR 0.20 [0.08, 0.50]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
objective responses (ORR) 0.95 [0.61, 1.49]> 10%1 study (1/-)41.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.67 [0.11, 4.10]< 10%1 study (1/-)66.6 %NAnot evaluable non important-
AE (grade 3-4) 1.38 [0.81, 2.33]< 10%1 study (1/-)11.7 %NAnot evaluable non important-
AE leading to death (grade 5) 0.73 [0.16, 3.34]< 10%1 study (1/-)65.7 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.44 [0.20, 0.99]< 10%1 study (1/-)97.6 %NAnot evaluable non important-
SAE (any grade) 1.79 [1.05, 3.05]< 10%1 study (1/-)1.6 %NAnot evaluable non important-
STRAE (any grade) 0.92 [0.48, 1.80]< 10%1 study (1/-)59.2 %NAnot evaluable non important-
TRAE (any grade) 0.38 [0.19, 0.79]< 10%1 study (1/-)99.6 %NAnot evaluable non important-
TRAE (grade 3-4) 0.55 [0.31, 0.99]< 10%1 study (1/-)97.6 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.98 [0.14, 7.10]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.37 [0.15, 0.92]< 10%1 study (1/-)98.4 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Anaemia TRAE (grade 3-4) 0.98 [0.19, 4.97]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.49 [0.04, 5.45]< 10%1 study (1/-)71.9 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.12 [0.01, 2.28]< 10%1 study (1/-)91.9 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 2.00 [0.36, 11.15]< 10%1 study (1/-)21.5 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.09 [0.01, 1.75]< 10%1 study (1/-)94.2 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.20 [0.04, 0.97]< 10%1 study (1/-)97.7 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 0.32 [0.03, 3.14]< 10%1 study (1/-)83.4 %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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