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renal cell cancer (RCC), nivolumab 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) 0.73 [0.57, 0.93]< 10%1 study (1/-)99.4 %NAnot evaluable crucial-
progression or deaths (PFS) 0.88 [0.75, 1.03]< 10%1 study (1/-)94.3 %NAnot evaluable important-
objective responses (ORR) 5.98 [3.68, 9.72]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

TRAE (any grade) 0.50 [0.34, 0.74]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.40 [0.29, 0.55]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.24 [0.01, 5.42]< 10%1 study (1/-)81.1 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.55 [0.34, 0.88]< 10%1 study (1/-)99.4 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Anaemia TRAE (grade 3-4) 0.21 [0.09, 0.48]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Cough TRAE (grade 3-4) 0.98 [0.02, 49.40]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.49 [0.09, 2.67]< 10%1 study (1/-)79.6 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.98 [0.28, 3.40]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Dysgeusia TRAE (grade 3-4) 0.98 [0.02, 49.40]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 1.47 [0.24, 8.85]< 10%1 study (1/-)33.8 %NAnot evaluable non important-
Epistaxis TRAE (grade 3-4) 0.98 [0.02, 49.40]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.89 [0.37, 2.11]< 10%1 study (1/-)60.7 %NAnot evaluable non important-
Mucosal inflammation TRAE (grade 3-4) 0.04 [0.00, 0.67]< 10%1 study (1/-)98.7 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.32 [0.03, 3.13]< 10%1 study (1/-)83.3 %NAnot evaluable non important-
Peripheral oedema TRAE (grade 3-4) 0.24 [0.01, 5.42]< 10%1 study (1/-)81.1 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 0.53 [0.19, 1.44]< 10%1 study (1/-)89.4 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.98 [0.02, 49.40]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.65 [0.11, 3.91]< 10%1 study (1/-)68.0 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 0.03 [0.00, 0.46]< 10%1 study (1/-)99.3 %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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