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mNSCLC - L2 - all population, nivolumab 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) 0.68 [0.52, 0.89]< 10%1 study (1/-)99.7 %NAnot evaluable crucial-
deaths (OS) (extension) 0.75 [0.61, 0.93]< 10%1 study (1/-)99.6 %NAnot evaluable important-
PFS (extension) 0.79 [0.64, 0.97]< 10%1 study (1/-)98.8 %NAnot evaluable important-
progression or deaths (PFS) 0.77 [0.62, 0.95]< 10%1 study (1/-)99.2 %NAnot evaluable important-
objective responses (ORR) 4.40 [1.99, 9.74]> 10%1 study (1/-)100.0 %NAnot evaluable non important-
objective responses (ORR) (extension) 4.80 [2.14, 10.77]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

STRAE (any grade) 0.59 [0.34, 1.02]< 10%1 study (1/-)96.9 %NAnot evaluable non important-
STRAE (grade 3-4) 0.34 [0.18, 0.66]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
TRAE (any grade) 0.35 [0.22, 0.57]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.15 [0.10, 0.24]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.61 [0.14, 2.77]< 10%1 study (1/-)73.7 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.66 [0.32, 1.37]< 10%1 study (1/-)86.9 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 0.80 [0.33, 1.95]< 10%1 study (1/-)68.6 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Acute kidney injury TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.15 [0.02, 1.47]< 10%1 study (1/-)94.7 %NAnot evaluable non important-
Blood creatinine increased TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.93 [0.03, 27.74]< 10%1 study (1/-)51.8 %NAnot evaluable non important-
Eczema TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Erythema TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.27 [0.06, 1.15]< 10%1 study (1/-)96.1 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 0.93 [0.03, 27.74]< 10%1 study (1/-)51.8 %NAnot evaluable non important-
Hepatobiliary disorders TRAE (grade 3-4) 1.39 [0.14, 13.49]< 10%1 study (1/-)38.8 %NAnot evaluable non important-
Hypersensitivity TRAE (grade 3-4) 0.23 [0.01, 6.90]< 10%1 study (1/-)79.8 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.46 [0.03, 7.42]< 10%1 study (1/-)70.6 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.46 [0.03, 7.42]< 10%1 study (1/-)70.6 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.02 [0.00, 0.18]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.03 [0.01, 0.15]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 3.74 [0.20, 71.10]< 10%1 study (1/-)19.3 %NAnot evaluable non important-
Pruritus generalised TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 2.79 [0.14, 56.11]< 10%1 study (1/-)25.4 %NAnot evaluable non important-
Renal and urinary disorders TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) 6.60 [0.37, 116.99]< 10%1 study (1/-)10.2 %NAnot evaluable non important-
Skin and subcutaneous tissue disorders TRAE (grade 3-4) 2.79 [0.14, 56.11]< 10%1 study (1/-)25.4 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
Vitiligo TRAE (grade 3-4) 0.46 [0.01, 23.40]< 10%1 study (1/-)64.7 %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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