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renal cell cancer (RCC), everolimus , 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) 1.26 [1.06, 1.51]< 10%2 studies (2/-)0.5 %some concernnot evaluable moderatecrucial-
progression or deaths (PFS) 0.86 [0.50, 1.49]< 194%2 studies (2/-)70.1 %some concernnot evaluable moderateimportant-
objective responses (ORR) 0.50 [0.06, 4.27]> 199%2 studies (2/-)26.6 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE (any grade) 5.28 [0.61, 45.46]< 10%1 study (1/-)6.6 %NAnot evaluable non important-
AE (grade 3-4) 1.53 [1.09, 2.14]< 10%1 study (1/-)0.7 %NAnot evaluable non important-
AE leading to death (grade 5) 1.98 [0.94, 4.14]< 10%1 study (1/-)3.6 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 2.20 [1.50, 3.23]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Arthralgia AE (grade 3-4) 4.84 [0.56, 41.67]< 10%1 study (1/-)7.7 %NAnot evaluable non important-
Constipation AE (grade 3-4) 1.92 [0.06, 57.36]< 10%1 study (1/-)35.6 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 4.43 [1.66, 11.83]< 10%1 study (1/-)0.2 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 2.34 [1.31, 4.15]< 10%1 study (1/-)0.2 %NAnot evaluable non important-
Dysgeusia AE (grade 3-4) 0.48 [0.02, 14.30]< 10%1 study (1/-)66.3 %NAnot evaluable non important-
Dysphonia AE (grade 3-4) 3.85 [0.17, 85.62]< 10%1 study (1/-)20.0 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 1.78 [0.93, 3.41]< 10%1 study (1/-)4.0 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 1.25 [0.87, 1.81]< 10%1 study (1/-)11.4 %NAnot evaluable non important-
Hypothyroidism AE (grade 3-4) 3.85 [0.17, 85.62]< 10%1 study (1/-)20.0 %NAnot evaluable non important-
Nausea AE (grade 3-4) 4.40 [0.94, 20.50]< 10%1 study (1/-)3.0 %NAnot evaluable non important-
Palmar–plantar erythrodysesthesia syndrome AE (grade 3-4) 0.73 [0.32, 1.69]< 10%1 study (1/-)77.0 %NAnot evaluable non important-
Proteinuria AE (grade 3-4) 2.94 [1.41, 6.12]< 10%1 study (1/-)0.2 %NAnot evaluable non important-
Rash AE (grade 3-4) 0.48 [0.04, 5.29]< 10%1 study (1/-)72.5 %NAnot evaluable non important-
Stomatitis AE (grade 3-4) 3.14 [1.32, 7.46]< 10%1 study (1/-)0.5 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 1.94 [0.66, 5.74]< 10%1 study (1/-)11.5 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 26.79 [3.61, 198.57]< 10%1 study (1/-)0.1 %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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