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mNSCLC - L1 - all population, durvalumab 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

deaths (OS) 0.96 [0.81, 1.13]< 10%1 study (1/-)68.5 %NAnot evaluable crucial-

safety endpoints 00

AE (any grade) 0.59 [0.31, 1.13]< 10%1 study (1/-)94.5 %NAnot evaluable non important-
AE (grade 3-4) 0.81 [0.60, 1.10]< 10%1 study (1/-)91.2 %NAnot evaluable non important-
AE leading to death (grade 5) 0.82 [0.38, 1.75]< 10%1 study (1/-)69.6 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.72 [0.47, 1.12]< 10%1 study (1/-)92.7 %NAnot evaluable non important-
AE leading to treatment discontinuation (grade 3-4) 1.10 [0.64, 1.89]< 10%1 study (1/-)35.9 %NAnot evaluable non important-
STRAE (any grade) 0.56 [0.35, 0.90]< 10%1 study (1/-)99.2 %NAnot evaluable non important-
STRAE (grade 3-4) 0.48 [0.28, 0.84]< 10%1 study (1/-)99.5 %NAnot evaluable non important-
TRAE (any grade) 0.24 [0.17, 0.34]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.34 [0.24, 0.49]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.63 [0.11, 3.82]< 10%1 study (1/-)69.0 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.55 [0.31, 0.99]< 10%1 study (1/-)97.8 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 1.28 [0.60, 2.75]< 10%1 study (1/-)26.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 1.91 [0.06, 57.12]< 10%1 study (1/-)35.6 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.95 [0.02, 48.21]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.01 [0.00, 0.19]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.12 [0.01, 0.94]< 10%1 study (1/-)97.8 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 1.91 [0.06, 57.12]< 10%1 study (1/-)35.6 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.48 [0.02, 14.24]< 10%1 study (1/-)66.3 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.24 [0.03, 2.13]< 10%1 study (1/-)90.0 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 0.95 [0.02, 48.21]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.95 [0.13, 6.81]< 10%1 study (1/-)51.9 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.81 [0.27, 2.45]< 10%1 study (1/-)64.2 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 1.91 [0.06, 57.12]< 10%1 study (1/-)35.6 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.95 [0.02, 48.21]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 0.95 [0.02, 48.21]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 3.83 [0.17, 85.25]< 10%1 study (1/-)20.1 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.08 [0.00, 1.41]< 10%1 study (1/-)95.6 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 0.95 [0.02, 48.21]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.02 [0.00, 0.18]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 3.85 [0.43, 34.59]< 10%1 study (1/-)11.6 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.95 [0.02, 48.21]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 2.88 [0.30, 27.79]< 10%1 study (1/-)18.2 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.03 [0.00, 0.42]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.07 [0.00, 1.18]< 10%1 study (1/-)96.6 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Alopecia AE (grade 3-4) 0.95 [0.02, 48.21]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.16 [0.07, 0.34]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.95 [0.41, 2.23]< 10%1 study (1/-)54.5 %NAnot evaluable non important-
Back pain AE (grade 3-4) 0.32 [0.03, 3.05]< 10%1 study (1/-)83.9 %NAnot evaluable non important-
Constipation AE (grade 3-4) 0.95 [0.06, 15.31]< 10%1 study (1/-)51.3 %NAnot evaluable non important-
Cough AE (grade 3-4) 1.91 [0.06, 57.12]< 10%1 study (1/-)35.6 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 1.44 [0.40, 5.14]< 10%1 study (1/-)28.8 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 0.38 [0.07, 1.96]< 10%1 study (1/-)87.6 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 1.61 [0.58, 4.47]< 10%1 study (1/-)18.2 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 1.20 [0.47, 3.07]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.16 [0.02, 1.31]< 10%1 study (1/-)95.6 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 0.07 [0.02, 0.24]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 0.95 [0.02, 48.21]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 5.76 [0.29, 115.45]< 10%1 study (1/-)12.9 %NAnot evaluable non important-
Rash AE (grade 3-4) 2.88 [0.30, 27.79]< 10%1 study (1/-)18.2 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.05 [0.01, 0.38]< 10%1 study (1/-)99.8 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.54 [0.16, 1.86]< 10%1 study (1/-)83.5 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 2.88 [0.30, 27.79]< 10%1 study (1/-)18.2 %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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