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urothelial cancer (UC) - bladder cancer (BC), 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) 0.84 [0.75, 0.95]< 10%2 studies (2/-)99.8 %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) 0.83 [0.72, 0.96]< 10%2 studies (2/-)99.4 %some concernnot evaluable moderateimportant-
CRR 1.96 [1.21, 3.17]> 10%1 study (1/-)99.7 %NAnot evaluable non important-
DOR 0.35 [0.08, 1.50]< 191%2 studies (2/-)92.1 %some concernnot evaluable moderatenon important-
objective responses (ORR) 1.10 [0.88, 1.37]> 10%2 studies (2/-)79.1 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE (any grade) 0.81 [0.14, 4.61]< 171%2 studies (2/-)59.5 %some concernnot evaluable moderatenon important-
AE (grade 3-4) 0.84 [0.68, 1.04]< 10%2 studies (2/-)94.5 %some concernnot evaluable moderatenon important-
AE leading to death (grade 5) 1.10 [0.70, 1.71]< 10%2 studies (2/-)34.1 %some concernnot evaluable moderatenon important-
AE leading to treatment discontinuation (any grade) 0.64 [0.23, 1.76]< 194%2 studies (2/-)80.8 %some concernnot evaluable moderatenon important-
SAE (any grade) 1.01 [0.83, 1.22]< 13%2 studies (2/-)47.1 %some concernnot evaluable moderatenon important-
STRAE (any grade) 0.87 [0.37, 2.02]< 193%2 studies (2/-)62.7 %some concernnot evaluable moderatenon important-
TRAE (any grade) 0.52 [0.14, 1.90]< 191%2 studies (2/-)83.8 %some concernnot evaluable moderatenon important-
TRAE (grade 3-4) 0.58 [0.19, 1.73]< 196%2 studies (2/-)83.6 %some concernnot evaluable moderatenon important-
TRAE leading to death (grade 5) 0.91 [0.20, 4.07]< 169%2 studies (2/-)54.9 %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) 0.70 [0.26, 1.88]< 178%2 studies (2/-)76.0 %some concernnot evaluable moderatenon important-
Asthenia TRAE (grade 3-4) 0.91 [0.20, 4.21]< 184%2 studies (2/-)54.9 %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) 2.59 [0.27, 25.03]< 10%1 study (1/-)20.7 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.92 [0.13, 6.29]< 183%2 studies (2/-)53.4 %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) 1.73 [0.31, 9.49]< 10%1 study (1/-)26.5 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.28 [0.01, 14.75]< 196%2 studies (2/-)73.1 %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) 1.72 [0.06, 51.51]< 10%1 study (1/-)37.9 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.86 [0.02, 43.49]< 10%1 study (1/-)52.9 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 1.11 [0.55, 2.26]< 10%1 study (1/-)38.6 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Anaemia AE (grade 3-4) 1.08 [0.82, 1.42]< 10%1 study (1/-)29.8 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 1.43 [0.81, 2.50]< 10%1 study (1/-)10.8 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.66 [0.37, 1.17]< 10%1 study (1/-)92.1 %NAnot evaluable non important-
Febrile neutropenia AE (grade 3-4) 1.76 [0.81, 3.80]< 10%1 study (1/-)7.7 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 2.22 [1.05, 4.68]< 10%1 study (1/-)1.8 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 0.74 [0.44, 1.24]< 10%1 study (1/-)87.3 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.54 [0.23, 1.27]< 10%1 study (1/-)92.0 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 1.38 [1.03, 1.84]< 10%1 study (1/-)1.5 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 1.25 [0.89, 1.76]< 10%1 study (1/-)10.1 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.86 [0.37, 2.00]< 10%1 study (1/-)63.9 %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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