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urothelial cancer (UC) - bladder cancer (BC), atezolizumab 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) 0.90 [0.80, 1.01]< 110%3 studies (3/-)96.4 %some concernnot evaluable moderatecrucial-
deaths (OS) (extension) 0.82 [0.71, 0.94]< 10%1 study (1/-)99.7 %NAnot evaluable important-
progression or deaths (PFS) 0.89 [0.60, 1.32]< 10%1 study (1/-)71.3 %NAnot evaluable important-
DOR 0.19 [0.12, 0.30]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
events or deaths (EFS) 0.89 [0.74, 1.08]< 10%1 study (1/-)88.7 %NAnot evaluable non important-
objective responses (ORR) 0.61 [0.24, 1.56]> 193%2 studies (2/-)15.2 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE (any grade) 0.24 [0.09, 0.66]< 156%2 studies (2/-)99.7 %some concernnot evaluable moderatenon important-
AE (grade 3-4) 0.31 [0.05, 2.00]< 199%2 studies (2/-)88.9 %some concernnot evaluable moderatenon important-
AE leading to death (grade 5) 1.23 [0.71, 2.13]< 133%2 studies (2/-)22.8 %some concernnot evaluable moderatenon important-
AE leading to treatment discontinuation (any grade) 0.22 [0.08, 0.62]< 190%2 studies (2/-)99.8 %some concernnot evaluable moderatenon important-
SAE (any grade) 0.85 [0.70, 1.04]< 10%2 studies (2/-)94.5 %some concernnot evaluable moderatenon important-
STRAE (any grade) 0.49 [0.35, 0.67]< 137%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
TRAE (any grade) 0.14 [0.03, 0.55]< 195%2 studies (2/-)99.7 %some concernnot evaluable moderatenon important-
TRAE (grade 3-4) 0.12 [0.02, 0.89]< 199%2 studies (2/-)98.0 %some concernnot evaluable moderatenon important-
TRAE leading to death (grade 5) 0.55 [0.22, 1.39]< 10%2 studies (2/-)89.8 %some concernnot evaluable moderatenon important-
TRAE leading to discontinuation (any grade) 0.22 [0.12, 0.38]< 10%1 study (1/-)100.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Anaemia TRAE (grade 3-4) 0.19 [0.03, 1.02]< 177%2 studies (2/-)97.3 %some concernnot evaluable moderatenon important-
Asthenia TRAE (grade 3-4) 0.48 [0.24, 0.95]< 10%2 studies (2/-)98.2 %some concernnot evaluable moderatenon important-
Constipation TRAE (grade 3-4) 0.02 [0.00, 0.38]< 10%1 study (1/-)99.5 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 2.21 [0.20, 24.48]< 10%1 study (1/-)26.1 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.42 [0.19, 0.92]< 10%2 studies (2/-)98.4 %some concernnot evaluable moderatenon important-
Febrile neutropenia TRAE (grade 3-4) 0.04 [0.00, 0.27]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.27 [0.01, 6.11]< 10%1 study (1/-)79.0 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.03 [0.01, 0.12]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
Peripheral neuropathy TRAE (grade 3-4) 0.12 [0.01, 0.95]< 10%1 study (1/-)97.7 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 1.10 [0.02, 55.68]< 10%1 study (1/-)48.1 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 4.43 [0.20, 98.49]< 10%1 study (1/-)17.7 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.08 [0.01, 0.58]< 10%1 study (1/-)99.3 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Anaemia AE (grade 3-4) 0.08 [0.05, 0.13]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.51 [0.24, 1.10]< 10%1 study (1/-)95.7 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.22 [0.09, 0.54]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Febrile neutropenia AE (grade 3-4) 0.05 [0.00, 0.92]< 10%1 study (1/-)97.7 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 0.54 [0.18, 1.61]< 10%1 study (1/-)86.4 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 0.02 [0.00, 0.25]< 10%1 study (1/-)99.8 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.08 [0.01, 0.58]< 10%1 study (1/-)99.3 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 0.00 [0.00, 0.05]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.01 [0.00, 0.10]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.10 [0.01, 0.76]< 10%1 study (1/-)98.6 %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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