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breast cancer - triple negative, durvalumab alone , 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) (extension) 0.24 [0.03, 2.28]< 10%1 study (1/-)89.2 %NAnot evaluable important-
pCR 1.45 [0.80, 2.63]> 10%1 study (1/-)88.9 %NAnot evaluable non important-

safety endpoints 00

AE leading to death (grade 5) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
SAE (any grade) 0.88 [0.47, 1.66]< 10%1 study (1/-)64.9 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

hepatitis (Autoimmune) AE (grade 3-4) 1.79 [0.06, 54.10]< 10%1 study (1/-)37.1 %NAnot evaluable non important-
Abdominal pain AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Alopecia AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.89 [0.12, 6.46]< 10%1 study (1/-)54.6 %NAnot evaluable non important-
Arthralgia AE (grade 3-4) 1.80 [0.16, 20.23]< 10%1 study (1/-)31.8 %NAnot evaluable non important-
Back pain AE (grade 3-4) 0.44 [0.01, 13.37]< 10%1 study (1/-)67.8 %NAnot evaluable non important-
Blood creatinine increased AE (grade 3-4) 0.05 [0.00, 0.89]< 10%1 study (1/-)97.8 %NAnot evaluable non important-
Constipation AE (grade 3-4) 0.89 [0.05, 14.46]< 10%1 study (1/-)53.2 %NAnot evaluable non important-
Cough AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 5.49 [0.27, 111.35]< 10%1 study (1/-)13.6 %NAnot evaluable non important-
Dry skin AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Epistaxis AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.47 [0.15, 1.45]< 10%1 study (1/-)90.6 %NAnot evaluable non important-
Febrile neutropenia AE (grade 3-4) 1.82 [0.32, 10.20]< 10%1 study (1/-)24.9 %NAnot evaluable non important-
Headache AE (grade 3-4) 1.79 [0.06, 54.10]< 10%1 study (1/-)37.1 %NAnot evaluable non important-
Hyperthyroidism AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Hypophysitis AE (grade 3-4) 1.79 [0.06, 54.10]< 10%1 study (1/-)37.1 %NAnot evaluable non important-
Hypothyroidism AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Increase AST AE (grade 3-4) 5.49 [0.27, 111.35]< 10%1 study (1/-)13.6 %NAnot evaluable non important-
Increased ALT AE (grade 3-4) 1.20 [0.26, 5.51]< 10%1 study (1/-)40.9 %NAnot evaluable non important-
Infusion-related reaction AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Injury, poisoning and procedure AE (grade 3-4) 0.89 [0.05, 14.46]< 10%1 study (1/-)53.2 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 0.84 [0.45, 1.57]< 10%1 study (1/-)70.9 %NAnot evaluable non important-
Myalgia AE (grade 3-4) 1.82 [0.32, 10.20]< 10%1 study (1/-)24.9 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.06 [0.00, 1.05]< 10%1 study (1/-)97.2 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 0.83 [0.45, 1.52]< 10%1 study (1/-)72.8 %NAnot evaluable non important-
Peripheral neuropathy AE (grade 3-4) 0.88 [0.33, 2.33]< 10%1 study (1/-)60.2 %NAnot evaluable non important-
Pneumonitis AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Rash AE (grade 3-4) 0.89 [0.05, 14.46]< 10%1 study (1/-)53.2 %NAnot evaluable non important-
Stomatitis AE (grade 3-4) 3.62 [0.16, 81.50]< 10%1 study (1/-)21.2 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.44 [0.04, 4.94]< 10%1 study (1/-)74.6 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.89 [0.05, 14.46]< 10%1 study (1/-)53.2 %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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