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breast cancer - HER2-positive, neratinib plus capecitabine , 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) 0.88 [0.74, 1.06]< 10%2 studies (2/-)91.2 %some concernnot evaluable moderatecrucial-
progression or deaths (PFS) 0.74 [0.62, 0.89]< 10%2 studies (2/-)99.9 %some concernnot evaluable moderateimportant-
DOR 0.50 [0.34, 0.73]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
objective responses (ORR) 1.02 [0.37, 2.80]> 10%1 study (1/-)51.4 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Anaemia AE (grade 3-4) 0.48 [0.02, 14.79]< 10%1 study (1/-)65.9 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.31 [0.03, 3.12]< 10%1 study (1/-)83.7 %NAnot evaluable non important-
Back pain AE (grade 3-4) 0.98 [0.02, 50.38]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Constipation AE (grade 3-4) 0.98 [0.02, 50.38]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.98 [0.06, 16.11]< 10%1 study (1/-)50.6 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 2.48 [0.79, 7.77]< 10%1 study (1/-)6.0 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.98 [0.13, 7.24]< 10%1 study (1/-)50.8 %NAnot evaluable non important-
Headache AE (grade 3-4) 0.98 [0.02, 50.38]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.64 [0.10, 4.00]< 10%1 study (1/-)68.3 %NAnot evaluable non important-
Palmar–plantar erythrodysesthesia syndrome AE (grade 3-4) 0.98 [0.29, 3.27]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 0.48 [0.02, 14.79]< 10%1 study (1/-)65.9 %NAnot evaluable non important-
Rash AE (grade 3-4) 0.48 [0.02, 14.79]< 10%1 study (1/-)65.9 %NAnot evaluable non important-
Stomatitis AE (grade 3-4) 0.48 [0.02, 14.79]< 10%1 study (1/-)65.9 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.98 [0.06, 16.11]< 10%1 study (1/-)50.6 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 0.98 [0.06, 16.11]< 10%1 study (1/-)50.6 %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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