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la/mBC - HER2 positive - 2nd Line (L2), target therapy , 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) 0.89 [0.70, 1.14]< 10%1 study (1/-)82.3 %NAnot evaluable crucial-
progression or deaths (PFS) 0.76 [0.59, 0.98]< 10%1 study (1/-)98.3 %NAnot evaluable important-
objective responses (ORR) 1.49 [0.96, 2.31]> 10%1 study (1/-)96.2 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Abdominal pain AE (grade 3-4) 1.35 [0.30, 6.09]< 10%1 study (1/-)34.9 %NAnot evaluable non important-
Alopecia AE (grade 3-4) 1.01 [0.02, 50.97]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.76 [0.36, 1.59]< 10%1 study (1/-)76.7 %NAnot evaluable non important-
Arthralgia AE (grade 3-4) 0.50 [0.02, 15.05]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 1.21 [0.37, 4.03]< 10%1 study (1/-)37.6 %NAnot evaluable non important-
Constipation AE (grade 3-4) 1.01 [0.14, 7.21]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
Cough AE (grade 3-4) 2.02 [0.07, 60.44]< 10%1 study (1/-)34.5 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 1.01 [0.06, 16.19]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 1.01 [0.32, 3.17]< 10%1 study (1/-)49.5 %NAnot evaluable non important-
Dizziness AE (grade 3-4) 2.02 [0.07, 60.44]< 10%1 study (1/-)34.5 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 0.50 [0.12, 2.01]< 10%1 study (1/-)83.5 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 1.67 [0.68, 4.10]< 10%1 study (1/-)13.2 %NAnot evaluable non important-
Febrile neutropenia AE (grade 3-4) 0.61 [0.25, 1.49]< 10%1 study (1/-)86.1 %NAnot evaluable non important-
Headache AE (grade 3-4) 1.01 [0.02, 50.97]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 2.55 [0.49, 13.25]< 10%1 study (1/-)13.4 %NAnot evaluable non important-
Increase AST AE (grade 3-4) 2.39 [0.61, 9.34]< 10%1 study (1/-)10.6 %NAnot evaluable non important-
Increased ALT AE (grade 3-4) 1.26 [0.34, 4.76]< 10%1 study (1/-)36.5 %NAnot evaluable non important-
Infusion-related reaction AE (grade 3-4) 8.17 [0.43, 155.30]< 10%1 study (1/-)8.3 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 4.08 [0.45, 36.72]< 10%1 study (1/-)10.7 %NAnot evaluable non important-
Mucosal inflammation AE (grade 3-4) 0.50 [0.02, 15.05]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Nausea AE (grade 3-4) 3.05 [0.31, 29.47]< 10%1 study (1/-)17.0 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 1.73 [1.08, 2.78]< 10%1 study (1/-)1.2 %NAnot evaluable non important-
Peripheral neuropathy AE (grade 3-4) 0.33 [0.03, 3.23]< 10%1 study (1/-)82.7 %NAnot evaluable non important-
Pneumonia AE (grade 3-4) 0.33 [0.07, 1.65]< 10%1 study (1/-)91.0 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 1.01 [0.06, 16.19]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Stomatitis AE (grade 3-4) 4.05 [0.18, 90.31]< 10%1 study (1/-)19.1 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.50 [0.09, 2.75]< 10%1 study (1/-)78.6 %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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