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) | 0.85 [0.68, 1.06] | < 1 | 75% | 7 studies (7/-) | 92.4 % | some concern | not evaluable | moderate | crucial | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
deaths (OS) (extension) | 0.76 [0.67, 0.86] | < 1 | 0% | 4 studies (4/-) | 100.0 % | low | not evaluable | high | important | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
progression or deaths (PFS) | 0.77 [0.63, 0.93] | < 1 | 77% | 6 studies (6/-) | 99.6 % | some concern | not evaluable | moderate | important | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RFS/DFS | 0.84 [0.70, 1.01] | < 1 | 0% | 1 study (1/-) | 96.5 % | NA | not evaluable | important | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
events or deaths (EFS) | 0.78 [0.47, 1.29] | < 1 | 0% | 1 study (1/-) | 83.4 % | NA | not evaluable | non important | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
events or deaths (EFS) (extended) | 0.89 [0.66, 1.22] | < 1 | 0% | 2 studies (2/-) | 76.3 % | some concern | not evaluable | moderate | non important | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
objective responses (ORR) | 2.02 [0.93, 4.41] | > 1 | 91% | 4 studies (4/-) | 96.2 % | some concern | not evaluable | moderate | non important | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
pCR | 1.42 [0.44, 4.60] | > 1 | 90% | 2 studies (2/-) | 71.9 % | some concern | not evaluable | moderate | 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.