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Extensive stage SCLC (Es-SCLC), durvalumab 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) 0.73 [0.59, 0.91]< 10%1 study (1/-)99.8 %NAnot evaluable crucial-
deaths (OS) (extension) 0.75 [0.62, 0.91]< 10%1 study (1/-)99.8 %NAnot evaluable important-
PFS (extension) 0.80 [0.66, 0.96]< 10%1 study (1/-)99.0 %NAnot evaluable important-
progression or deaths (PFS) 0.78 [0.65, 0.94]< 10%1 study (1/-)99.6 %NAnot evaluable important-
objective responses (ORR) 1.64 [1.11, 2.43]> 10%1 study (1/-)99.3 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 1.61 [0.52, 4.99]< 10%1 study (1/-)20.4 %NAnot evaluable non important-
AE (grade 3-4) 0.96 [0.68, 1.37]< 10%1 study (1/-)58.4 %NAnot evaluable non important-
AE leading to death (grade 5) 0.86 [0.40, 1.85]< 10%1 study (1/-)64.7 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 1.00 [0.56, 1.80]< 10%1 study (1/-)49.4 %NAnot evaluable non important-
AE leading to treatment discontinuation (grade 3-4) 1.00 [0.35, 2.90]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
SAE (any grade) 0.79 [0.55, 1.14]< 10%1 study (1/-)89.5 %NAnot evaluable non important-
SAE (grade 3-4) 0.77 [0.51, 1.15]< 10%1 study (1/-)90.3 %NAnot evaluable non important-
STRAE (any grade) 0.66 [0.41, 1.05]< 10%1 study (1/-)96.0 %NAnot evaluable non important-
STRAE (grade 3-4) 0.51 [0.30, 0.86]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
TRAE (any grade) 0.92 [0.52, 1.61]< 10%1 study (1/-)61.9 %NAnot evaluable non important-
TRAE (grade 3-4) 0.78 [0.55, 1.10]< 10%1 study (1/-)92.4 %NAnot evaluable non important-
TRAE leading to death (grade 5) 2.54 [0.49, 13.20]< 10%1 study (1/-)13.5 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 1.17 [0.54, 2.50]< 10%1 study (1/-)34.5 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 0.75 [0.17, 3.38]< 10%1 study (1/-)64.5 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 1.51 [0.25, 9.12]< 10%1 study (1/-)32.7 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.52 [0.29, 0.91]< 10%1 study (1/-)98.9 %NAnot evaluable non important-
Arthritis TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 1.00 [0.14, 7.18]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 1.00 [0.06, 16.13]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 8.14 [0.43, 154.70]< 10%1 study (1/-)8.4 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 1.00 [0.14, 7.18]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.67 [0.11, 4.02]< 10%1 study (1/-)67.0 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.76 [0.36, 1.59]< 10%1 study (1/-)77.0 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 8.25 [1.02, 66.42]< 10%1 study (1/-)2.4 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 1.08 [0.51, 2.28]< 10%1 study (1/-)42.0 %NAnot evaluable non important-
Myocarditis TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.10 [0.01, 1.82]< 10%1 study (1/-)93.8 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.63 [0.43, 0.92]< 10%1 study (1/-)99.2 %NAnot evaluable non important-
Paraesthesia TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 2.02 [0.18, 22.36]< 10%1 study (1/-)28.6 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.56 [0.28, 1.11]< 10%1 study (1/-)95.1 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.25 [0.01, 5.56]< 10%1 study (1/-)80.7 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Alopecia AE (grade 3-4) 1.51 [0.25, 9.12]< 10%1 study (1/-)32.7 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.45 [0.27, 0.76]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 1.69 [0.40, 7.13]< 10%1 study (1/-)23.9 %NAnot evaluable non important-
Back pain AE (grade 3-4) 2.02 [0.18, 22.36]< 10%1 study (1/-)28.6 %NAnot evaluable non important-
Constipation AE (grade 3-4) 4.04 [0.18, 89.97]< 10%1 study (1/-)19.2 %NAnot evaluable non important-
Cough AE (grade 3-4) 4.04 [0.18, 89.97]< 10%1 study (1/-)19.2 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 1.00 [0.14, 7.18]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 1.00 [0.20, 5.02]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 1.69 [0.40, 7.13]< 10%1 study (1/-)23.9 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 1.34 [0.30, 6.06]< 10%1 study (1/-)35.1 %NAnot evaluable non important-
Febrile neutropenia AE (grade 3-4) 0.82 [0.39, 1.69]< 10%1 study (1/-)70.7 %NAnot evaluable non important-
Headache AE (grade 3-4) 2.01 [0.07, 60.21]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 8.25 [1.02, 66.42]< 10%1 study (1/-)2.4 %NAnot evaluable non important-
Hyperthyroidism AE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Increased Lipase Level AE (grade 3-4) 2.30 [0.70, 7.57]< 10%1 study (1/-)8.5 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 1.23 [0.60, 2.56]< 10%1 study (1/-)28.6 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.20 [0.02, 1.70]< 10%1 study (1/-)92.9 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 0.64 [0.44, 0.94]< 10%1 study (1/-)98.8 %NAnot evaluable non important-
Pneumonia AE (grade 3-4) 0.55 [0.18, 1.66]< 10%1 study (1/-)85.5 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 0.50 [0.02, 15.00]< 10%1 study (1/-)65.3 %NAnot evaluable non important-
Rash AE (grade 3-4) 1.00 [0.02, 50.78]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.58 [0.30, 1.12]< 10%1 study (1/-)94.7 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.17 [0.01, 3.32]< 10%1 study (1/-)87.7 %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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