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es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA), pembrolizumab 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

events or deaths (EFS) 0.63 [0.43, 0.93]< 10%1 study (1/-)99.1 %NAnot evaluable non important-
pCR 13.60 [6.77, 27.33]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.25 [0.01, 4.74]< 10%1 study (1/-)81.9 %NAnot evaluable non important-
AE (grade 3-4) 1.35 [1.01, 1.80]< 10%1 study (1/-)2.2 %NAnot evaluable non important-
TRAE (any grade) 0.25 [0.03, 2.00]< 10%1 study (1/-)90.3 %NAnot evaluable non important-
TRAE (grade 3-4) 1.26 [0.96, 1.66]< 10%1 study (1/-)4.9 %NAnot evaluable non important-
TRAE leading to death (grade 5) 1.50 [0.16, 14.43]< 10%1 study (1/-)36.5 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 2.16 [1.53, 3.05]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 10.08 [0.59, 173.00]< 10%1 study (1/-)5.7 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.87 [0.36, 2.09]< 10%1 study (1/-)62.3 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 1.27 [0.91, 1.77]< 10%1 study (1/-)8.1 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 1.40 [0.65, 3.02]< 10%1 study (1/-)19.9 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 3.51 [0.43, 28.62]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 3.51 [0.43, 28.62]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 1.99 [0.09, 44.34]< 10%1 study (1/-)33.3 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 1.71 [0.63, 4.67]< 10%1 study (1/-)14.8 %NAnot evaluable non important-
Dysgeusia TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 2.29 [0.94, 5.58]< 10%1 study (1/-)3.5 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 1.13 [0.82, 1.57]< 10%1 study (1/-)22.9 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 9.06 [0.52, 156.66]< 10%1 study (1/-)6.7 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.99 [0.09, 44.34]< 10%1 study (1/-)33.3 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 8.04 [0.46, 140.38]< 10%1 study (1/-)7.9 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 3.00 [0.15, 59.96]< 10%1 study (1/-)23.9 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 9.67 [1.29, 72.54]< 10%1 study (1/-)1.4 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 2.34 [1.13, 4.86]< 10%1 study (1/-)1.1 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 2.53 [0.86, 7.45]< 10%1 study (1/-)4.6 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.76 [0.57, 1.03]< 10%1 study (1/-)96.3 %NAnot evaluable non important-
Myocarditis TRAE (grade 3-4) 1.99 [0.09, 44.34]< 10%1 study (1/-)33.3 %NAnot evaluable non important-
Myositis TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 2.64 [1.01, 6.94]< 10%1 study (1/-)2.4 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 7.03 [0.40, 124.15]< 10%1 study (1/-)9.4 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 1.06 [0.82, 1.38]< 10%1 study (1/-)31.6 %NAnot evaluable non important-
Pancreatitis TRAE (grade 3-4) 4.00 [0.21, 75.85]< 10%1 study (1/-)18.1 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 1.88 [0.62, 5.72]< 10%1 study (1/-)13.2 %NAnot evaluable non important-
Peripheral sensory neuropathy TRAE (grade 3-4) 1.20 [0.42, 3.43]< 10%1 study (1/-)36.8 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 1.50 [0.16, 14.43]< 10%1 study (1/-)36.5 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 4.02 [0.50, 32.22]< 10%1 study (1/-)9.7 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 3.51 [0.43, 28.62]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Sarcoidosis TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Severe skin reaction TRAE (grade 3-4) 15.50 [2.11, 114.09]< 10%1 study (1/-)0.4 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 11.10 [0.65, 189.37]< 10%1 study (1/-)5.0 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 1.99 [0.09, 44.34]< 10%1 study (1/-)33.3 %NAnot evaluable non important-
Uveitis TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 1.51 [0.59, 3.82]< 10%1 study (1/-)19.5 %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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