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mUC - L1 - all population, 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) 1.02 [0.83, 1.25]< 10%1 study (1/-)42.3 %NAnot evaluable crucial-
DOR 0.21 [0.12, 0.37]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
objective responses (ORR) 0.38 [0.28, 0.53]> 10%1 study (1/-)0.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.14 [0.05, 0.40]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
AE (grade 3-4) 0.12 [0.08, 0.17]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
AE leading to death (grade 5) 1.59 [0.88, 2.87]< 10%1 study (1/-)6.3 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.13 [0.08, 0.21]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
SAE (any grade) 0.78 [0.59, 1.05]< 10%1 study (1/-)95.0 %NAnot evaluable non important-
STRAE (any grade) 0.41 [0.28, 0.60]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (any grade) 0.07 [0.04, 0.11]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.04 [0.03, 0.06]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.82 [0.18, 3.71]< 10%1 study (1/-)59.9 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Anaemia TRAE (grade 3-4) 0.07 [0.02, 0.30]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.63 [0.18, 2.15]< 10%1 study (1/-)77.1 %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) 0.73 [0.12, 4.41]< 10%1 study (1/-)63.2 %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 [0.00, 0.52]< 10%1 study (1/-)99.2 %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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