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urothelial cancer (UC) - bladder cancer (BC), atezolizumab based treatment , 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) 0.88 [0.80, 0.97]< 10%4 studies (4/-)99.6 %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 0.30 [0.11, 0.78]< 188%3 studies (3/-)99.3 %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) 0.76 [0.38, 1.53]> 193%3 studies (3/-)22.1 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE (any grade) 0.43 [0.11, 1.58]< 174%3 studies (3/-)89.9 %some concernnot evaluable moderatenon important-
AE (grade 3-4) 0.45 [0.13, 1.54]< 198%3 studies (3/-)89.9 %some concernnot evaluable moderatenon important-
AE leading to death (grade 5) 1.25 [0.88, 1.79]< 10%3 studies (3/-)10.6 %some concernnot evaluable moderatenon important-
AE leading to treatment discontinuation (any grade) 0.38 [0.11, 1.27]< 197%3 studies (3/-)94.2 %some concernnot evaluable moderatenon important-
SAE (any grade) 0.93 [0.77, 1.13]< 134%3 studies (3/-)75.9 %some concernnot evaluable moderatenon important-
STRAE (any grade) 0.68 [0.33, 1.38]< 192%3 studies (3/-)85.8 %some concernnot evaluable moderatenon important-
TRAE (any grade) 0.27 [0.07, 1.00]< 195%3 studies (3/-)97.5 %some concernnot evaluable moderatenon important-
TRAE (grade 3-4) 0.24 [0.05, 1.31]< 199%3 studies (3/-)94.9 %some concernnot evaluable moderatenon important-
TRAE leading to death (grade 5) 0.89 [0.35, 2.26]< 138%3 studies (3/-)59.9 %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) 0.37 [0.10, 1.37]< 186%3 studies (3/-)93.1 %some concernnot evaluable moderatenon important-
Asthenia TRAE (grade 3-4) 0.81 [0.30, 2.24]< 169%3 studies (3/-)65.4 %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) 2.41 [0.46, 12.52]< 10%2 studies (2/-)14.9 %some concernnot evaluable moderatenon important-
Fatigue TRAE (grade 3-4) 0.84 [0.23, 3.04]< 166%3 studies (3/-)60.4 %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) 1.11 [0.24, 5.19]< 14%2 studies (2/-)44.8 %some concernnot evaluable moderatenon important-
Neutropenia TRAE (grade 3-4) 0.15 [0.01, 3.89]< 194%3 studies (3/-)87.1 %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) 1.42 [0.11, 18.55]< 10%2 studies (2/-)39.5 %some concernnot evaluable moderatenon important-
Rash TRAE (grade 3-4) 2.36 [0.21, 26.86]< 10%2 studies (2/-)24.7 %some concernnot evaluable moderatenon important-
Thrombocytopenia TRAE (grade 3-4) 0.35 [0.03, 4.69]< 183%2 studies (2/-)78.5 %some concernnot evaluable moderatenon important-

AE (grade 3-4) endpoints 00

Anaemia AE (grade 3-4) 0.29 [0.02, 3.86]< 199%2 studies (2/-)82.3 %some concernnot evaluable moderatenon important-
Asthenia AE (grade 3-4) 0.88 [0.32, 2.41]< 178%2 studies (2/-)59.5 %some concernnot evaluable moderatenon important-
Fatigue AE (grade 3-4) 0.41 [0.14, 1.17]< 175%2 studies (2/-)95.2 %some concernnot evaluable moderatenon important-
Febrile neutropenia AE (grade 3-4) 0.41 [0.01, 11.84]< 181%2 studies (2/-)69.7 %some concernnot evaluable moderatenon important-
Hypertension AE (grade 3-4) 1.16 [0.29, 4.59]< 177%2 studies (2/-)41.4 %some concernnot evaluable moderatenon important-
Leucopenia AE (grade 3-4) 0.14 [0.00, 5.94]< 186%2 studies (2/-)84.5 %some concernnot evaluable moderatenon important-
Nausea AE (grade 3-4) 0.26 [0.04, 1.67]< 167%2 studies (2/-)92.2 %some concernnot evaluable moderatenon important-
Neutropenia AE (grade 3-4) 0.08 [0.00, 29.10]< 194%2 studies (2/-)79.0 %some concernnot evaluable moderatenon important-
Thrombocytopenia AE (grade 3-4) 0.14 [0.00, 12.34]< 195%2 studies (2/-)79.8 %some concernnot evaluable moderatenon important-
Vomiting AE (grade 3-4) 0.36 [0.04, 2.88]< 173%2 studies (2/-)83.2 %some concernnot evaluable moderatenon 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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