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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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efficacy endpoints 00 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
deaths (OS) | 1.44 [0.46, 4.49] | < 1 | 0% | 1 study (1/-) | 26.5 % | NA | not evaluable | crucial | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PFS (extension) | 0.47 [0.10, 2.27] | < 1 | 0% | 1 study (1/-) | 82.6 % | NA | not evaluable | important | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
progression or deaths (PFS) | 0.38 [0.15, 0.98] | < 1 | 0% | 1 study (1/-) | 97.7 % | NA | not evaluable | important | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
objective responses (ORR) | 9.82 [0.45, 212.91] | > 1 | 0% | 1 study (1/-) | 92.5 % | NA | not evaluable | non important | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
objective responses (ORR) (extension) | 9.80 [0.45, 211.42] | > 1 | 0% | 1 study (1/-) | 92.5 % | NA | not 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.