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metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2), avelumab based treatment , 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) 0.90 [0.78, 1.04]< 10%2 studies (2/-)92.9 %some concernnot evaluable moderatecrucial-
progression or deaths (PFS) 1.10 [0.95, 1.27]< 10%2 studies (2/-)9.7 %some concernnot evaluable moderateimportant-
objective responses (ORR) 1.54 [1.12, 2.12]> 10%2 studies (2/-)99.6 %some concernnot evaluable moderatenon important-

safety endpoints 00

STRAE (any grade) 0.37 [0.24, 0.57]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (any grade) 0.29 [0.21, 0.42]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.12 [0.08, 0.18]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.19 [0.05, 0.68]< 10%1 study (1/-)99.5 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.47 [0.29, 0.77]< 10%1 study (1/-)99.9 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Acute kidney injury TRAE (grade 3-4) 0.93 [0.02, 46.93]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Adrenal insufficiency TRAE (grade 3-4) 1.86 [0.06, 55.60]< 10%1 study (1/-)36.2 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.93 [0.02, 46.93]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.03 [0.00, 0.44]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
Arthralgia TRAE (grade 3-4) 0.46 [0.02, 13.86]< 10%1 study (1/-)66.9 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.06 [0.01, 0.49]< 10%1 study (1/-)99.6 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 3.73 [0.17, 82.97]< 10%1 study (1/-)20.6 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.07 [0.00, 1.15]< 10%1 study (1/-)96.7 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.11 [0.01, 2.18]< 10%1 study (1/-)92.3 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 0.46 [0.04, 5.13]< 10%1 study (1/-)73.3 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.09 [0.01, 0.71]< 10%1 study (1/-)98.8 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.01 [0.00, 0.20]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Headache TRAE (grade 3-4) 0.46 [0.02, 13.86]< 10%1 study (1/-)66.9 %NAnot evaluable non important-
Hypersensitivity TRAE (grade 3-4) 0.46 [0.02, 13.86]< 10%1 study (1/-)66.9 %NAnot evaluable non important-
Hypertension TRAE (grade 3-4) 1.86 [0.17, 20.62]< 10%1 study (1/-)30.8 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.86 [0.06, 55.60]< 10%1 study (1/-)36.2 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 3.73 [0.17, 82.97]< 10%1 study (1/-)20.6 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 3.74 [0.42, 33.65]< 10%1 study (1/-)12.1 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 5.64 [0.68, 47.10]< 10%1 study (1/-)5.6 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.05 [0.00, 0.78]< 10%1 study (1/-)98.3 %NAnot evaluable non important-
Mucosal inflammation TRAE (grade 3-4) 0.11 [0.01, 2.18]< 10%1 study (1/-)92.3 %NAnot evaluable non important-
Myalgia TRAE (grade 3-4) 0.15 [0.01, 3.08]< 10%1 study (1/-)88.7 %NAnot evaluable non important-
Myocarditis TRAE (grade 3-4) 0.93 [0.02, 46.93]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.15 [0.01, 3.08]< 10%1 study (1/-)88.7 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.01 [0.00, 0.13]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) 0.46 [0.02, 13.86]< 10%1 study (1/-)66.9 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 0.15 [0.01, 3.08]< 10%1 study (1/-)88.7 %NAnot evaluable non important-
Peripheral oedema TRAE (grade 3-4) 0.15 [0.01, 3.08]< 10%1 study (1/-)88.7 %NAnot evaluable non important-
Peripheral sensory neuropathy TRAE (grade 3-4) 0.46 [0.02, 13.86]< 10%1 study (1/-)66.9 %NAnot evaluable non important-
Pneumonia TRAE (grade 3-4) 0.09 [0.00, 1.68]< 10%1 study (1/-)94.4 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 2.80 [0.29, 27.04]< 10%1 study (1/-)18.8 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.93 [0.02, 46.93]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Sepsis TRAE (grade 3-4) 0.23 [0.01, 5.14]< 10%1 study (1/-)82.0 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 0.15 [0.01, 3.08]< 10%1 study (1/-)88.7 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.15 [0.01, 3.08]< 10%1 study (1/-)88.7 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 0.93 [0.06, 14.90]< 10%1 study (1/-)52.1 %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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