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muscular invasive bladder cancer (MIBC), nivolumab 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

RFS/DFS 0.72 [0.59, 0.88]< 10%1 study (1/-)99.9 %NAnot evaluable important-
DMFS 0.75 [0.59, 0.95]< 10%1 study (1/-)99.2 %NAnot evaluable non important-
events or deaths (EFS) 0.70 [0.55, 0.90]< 10%1 study (1/-)99.8 %NAnot evaluable non important-

safety endpoints 00

TRAE (any grade) 2.84 [2.05, 3.92]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE (grade 3-4) 1.28 [0.95, 1.74]< 10%1 study (1/-)5.4 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Acute kidney injury TRAE (grade 3-4) 3.98 [0.18, 88.64]< 10%1 study (1/-)19.4 %NAnot evaluable non important-
Adrenal insufficiency TRAE (grade 3-4) 0.99 [0.02, 50.11]< 10%1 study (1/-)50.2 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 3.98 [0.18, 88.64]< 10%1 study (1/-)19.4 %NAnot evaluable non important-
Blood creatinine increased TRAE (grade 3-4) 1.99 [0.07, 59.38]< 10%1 study (1/-)34.8 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 1.49 [0.25, 8.98]< 10%1 study (1/-)33.2 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 3.98 [0.18, 88.64]< 10%1 study (1/-)19.4 %NAnot evaluable non important-
Dermatitis acneiform TRAE (grade 3-4) 0.99 [0.02, 50.11]< 10%1 study (1/-)50.2 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 0.99 [0.02, 50.11]< 10%1 study (1/-)50.2 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 2.99 [0.31, 28.90]< 10%1 study (1/-)17.3 %NAnot evaluable non important-
Eczema TRAE (grade 3-4) 0.99 [0.02, 50.11]< 10%1 study (1/-)50.2 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 1.99 [0.07, 59.38]< 10%1 study (1/-)34.8 %NAnot evaluable non important-
Erythema TRAE (grade 3-4) 0.99 [0.02, 50.11]< 10%1 study (1/-)50.2 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 1.99 [0.07, 59.38]< 10%1 study (1/-)34.8 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 2.00 [0.50, 8.06]< 10%1 study (1/-)16.5 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 1.99 [0.07, 59.38]< 10%1 study (1/-)34.8 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 3.98 [0.18, 88.64]< 10%1 study (1/-)19.4 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 3.98 [0.18, 88.64]< 10%1 study (1/-)19.4 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.99 [0.02, 50.11]< 10%1 study (1/-)50.2 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 1.99 [0.07, 59.38]< 10%1 study (1/-)34.8 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 1.99 [0.07, 59.38]< 10%1 study (1/-)34.8 %NAnot evaluable non important-
Pruritic rash TRAE (grade 3-4) 0.99 [0.02, 50.11]< 10%1 study (1/-)50.2 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.99 [0.02, 50.11]< 10%1 study (1/-)50.2 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 3.98 [0.18, 88.64]< 10%1 study (1/-)19.4 %NAnot evaluable non important-
Renal and urinary disorders TRAE (grade 3-4) 8.01 [0.42, 152.12]< 10%1 study (1/-)8.5 %NAnot evaluable non important-
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) 5.99 [0.30, 120.06]< 10%1 study (1/-)12.4 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 0.99 [0.02, 50.11]< 10%1 study (1/-)50.2 %NAnot evaluable non important-
Urticaria TRAE (grade 3-4) 0.99 [0.02, 50.11]< 10%1 study (1/-)50.2 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Skin and subcutaneous tissue disorders AE (grade 3-4) 12.09 [0.67, 217.24]< 10%1 study (1/-)4.7 %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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