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mNSCLC - L2 - PDL1 negative, durvalumab plus tremelimumab , 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) 0.80 [0.61, 1.05]< 10%1 study (1/-)94.6 %NAnot evaluable crucial-
progression or deaths (PFS) 0.77 [0.59, 1.01]< 10%1 study (1/-)97.2 %NAnot evaluable important-
objective responses (ORR) 2.43 [1.05, 5.65]> 10%1 study (1/-)98.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.59 [0.20, 1.69]< 10%1 study (1/-)83.8 %NAnot evaluable non important-
AE (grade 3-4) 0.70 [0.43, 1.12]< 10%1 study (1/-)93.1 %NAnot evaluable non important-
AE leading to death (grade 5) 1.41 [0.52, 3.82]< 10%1 study (1/-)25.1 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 1.09 [0.58, 2.03]< 10%1 study (1/-)39.7 %NAnot evaluable non important-
SAE (any grade) 1.76 [1.04, 2.99]< 10%1 study (1/-)1.8 %NAnot evaluable non important-
TRAE (any grade) 0.39 [0.22, 0.69]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
TRAE (grade 3-4) 0.49 [0.29, 0.84]< 10%1 study (1/-)99.6 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 1.81 [0.81, 4.05]< 10%1 study (1/-)7.5 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Acute kidney injury TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Adrenal insufficiency TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.21 [0.02, 2.02]< 10%1 study (1/-)91.1 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 3.86 [0.19, 77.90]< 10%1 study (1/-)19.2 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.63 [0.09, 4.55]< 10%1 study (1/-)67.5 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 3.24 [0.37, 28.15]< 10%1 study (1/-)14.4 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 2.56 [0.11, 57.33]< 10%1 study (1/-)27.9 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.47 [0.10, 2.13]< 10%1 study (1/-)83.6 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 1.92 [0.20, 18.73]< 10%1 study (1/-)28.8 %NAnot evaluable non important-
Hypersensitivity TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Hypertension TRAE (grade 3-4) 1.27 [0.11, 14.23]< 10%1 study (1/-)42.2 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.63 [0.04, 10.24]< 10%1 study (1/-)62.5 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.10 [0.01, 2.08]< 10%1 study (1/-)92.8 %NAnot evaluable non important-
Myositis TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.03 [0.00, 0.45]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
Pancreatitis TRAE (grade 3-4) 2.56 [0.11, 57.33]< 10%1 study (1/-)27.9 %NAnot evaluable non important-
Peripheral oedema TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Pneumonia TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 6.52 [0.35, 120.50]< 10%1 study (1/-)10.6 %NAnot evaluable non important-
Pruritic rash TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.32 [0.01, 9.50]< 10%1 study (1/-)74.3 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.31 [0.03, 3.50]< 10%1 study (1/-)82.5 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.16 [0.01, 3.50]< 10%1 study (1/-)87.6 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.32 [0.01, 9.50]< 10%1 study (1/-)74.3 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %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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