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mML - NA - all population, 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

MFS 0.53 [0.37, 0.76]< 10%1 study (1/-)100.0 %NAnot evaluable important-
RFS (extension) 0.59 [0.49, 0.71]< 10%1 study (1/-)100.0 %NAnot evaluable important-
RFS/DFS 0.57 [0.43, 0.75]< 10%1 study (1/-)100.0 %NAnot evaluable important-
DMFS 0.60 [0.49, 0.73]< 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 1.51 [0.96, 2.38]< 10%1 study (1/-)3.8 %NAnot evaluable non important-
AE (grade 3-4) 2.03 [1.52, 2.73]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE (any grade) 6.05 [4.24, 8.63]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE (grade 3-4) 12.66 [3.87, 41.39]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 1.97 [0.07, 58.99]< 10%1 study (1/-)34.9 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 1.97 [0.07, 58.99]< 10%1 study (1/-)34.9 %NAnot evaluable non important-
Arthralgia TRAE (grade 3-4) 5.95 [0.30, 119.02]< 10%1 study (1/-)12.5 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 10.04 [1.28, 78.73]< 10%1 study (1/-)1.5 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 9.95 [0.54, 182.62]< 10%1 study (1/-)6.3 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 1.32 [0.29, 5.92]< 10%1 study (1/-)36.0 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 1.97 [0.07, 58.99]< 10%1 study (1/-)34.9 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 18.05 [1.04, 312.27]< 10%1 study (1/-)2.4 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 5.01 [1.09, 22.98]< 10%1 study (1/-)1.9 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 6.99 [0.86, 56.99]< 10%1 study (1/-)3.6 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.97 [0.07, 58.99]< 10%1 study (1/-)34.9 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 5.95 [0.30, 119.02]< 10%1 study (1/-)12.5 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.99 [0.02, 49.80]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Myocarditis TRAE (grade 3-4) 1.97 [0.07, 58.99]< 10%1 study (1/-)34.9 %NAnot evaluable non important-
Myositis TRAE (grade 3-4) 0.99 [0.02, 49.80]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.99 [0.02, 49.80]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 3.96 [0.18, 87.96]< 10%1 study (1/-)19.5 %NAnot evaluable non important-
Pancreatitis TRAE (grade 3-4) 0.99 [0.06, 15.81]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 7.94 [0.42, 150.67]< 10%1 study (1/-)8.6 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.99 [0.02, 49.80]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 1.97 [0.07, 58.99]< 10%1 study (1/-)34.9 %NAnot evaluable non important-
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) 7.94 [0.42, 150.67]< 10%1 study (1/-)8.6 %NAnot evaluable non important-
Sarcoidosis TRAE (grade 3-4) 0.99 [0.02, 49.80]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Severe skin reaction TRAE (grade 3-4) 5.95 [0.30, 119.02]< 10%1 study (1/-)12.5 %NAnot evaluable non important-
Skin and subcutaneous tissue disorders TRAE (grade 3-4) 1.97 [0.07, 58.99]< 10%1 study (1/-)34.9 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 0.99 [0.02, 49.80]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Uveitis TRAE (grade 3-4) 0.99 [0.02, 49.80]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Vitiligo TRAE (grade 3-4) 0.99 [0.02, 49.80]< 10%1 study (1/-)50.3 %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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