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lung cancer : small cell (SCLC), durvalumab plus tremelimumab plus SoC , 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) 0.82 [0.68, 0.99]< 10%1 study (1/-)97.8 %NAnot evaluable crucial-
progression or deaths (PFS) 0.84 [0.70, 1.01]< 10%1 study (1/-)96.9 %NAnot evaluable important-
objective responses (ORR) 1.02 [0.72, 1.44]> 10%1 study (1/-)54.5 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 4.09 [0.86, 19.46]< 10%1 study (1/-)3.9 %NAnot evaluable non important-
AE (grade 3-4) 1.05 [0.74, 1.49]< 10%1 study (1/-)39.4 %NAnot evaluable non important-
AE leading to death (grade 5) 1.89 [0.98, 3.64]< 10%1 study (1/-)2.9 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 2.63 [1.59, 4.36]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
STRAE (any grade) 1.45 [0.96, 2.20]< 10%1 study (1/-)3.8 %NAnot evaluable non important-
STRAE (grade 3-4) 1.28 [0.83, 1.98]< 10%1 study (1/-)13.4 %NAnot evaluable non important-
TRAE (any grade) 1.04 [0.59, 1.84]< 10%1 study (1/-)44.2 %NAnot evaluable non important-
TRAE (grade 3-4) 1.15 [0.81, 1.61]< 10%1 study (1/-)21.7 %NAnot evaluable non important-
TRAE leading to death (grade 5) 6.24 [1.38, 28.14]< 10%1 study (1/-)0.9 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 3.75 [1.97, 7.16]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 7.10 [2.44, 20.63]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 6.06 [0.30, 121.51]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.25 [0.01, 5.54]< 10%1 study (1/-)80.7 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.68 [0.40, 1.15]< 10%1 study (1/-)92.6 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 1.51 [0.25, 9.08]< 10%1 study (1/-)32.8 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 2.00 [0.07, 59.99]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 2.01 [0.18, 22.28]< 10%1 study (1/-)28.7 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 4.02 [0.18, 89.63]< 10%1 study (1/-)19.3 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 3.57 [0.73, 17.33]< 10%1 study (1/-)5.8 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.66 [0.11, 4.01]< 10%1 study (1/-)67.2 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.69 [0.32, 1.48]< 10%1 study (1/-)82.9 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 2.00 [0.07, 59.99]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 2.00 [0.07, 59.99]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 4.02 [0.18, 89.63]< 10%1 study (1/-)19.3 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 5.08 [0.59, 43.75]< 10%1 study (1/-)7.1 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 1.08 [0.51, 2.28]< 10%1 study (1/-)42.4 %NAnot evaluable non important-
Myocarditis TRAE (grade 3-4) 2.00 [0.07, 59.99]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.60 [0.14, 2.52]< 10%1 study (1/-)75.9 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.92 [0.64, 1.32]< 10%1 study (1/-)68.0 %NAnot evaluable non important-
Paraesthesia TRAE (grade 3-4) 2.00 [0.07, 59.99]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 3.02 [0.31, 29.25]< 10%1 study (1/-)17.1 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 1.00 [0.02, 50.59]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 6.06 [0.30, 121.51]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.91 [0.50, 1.67]< 10%1 study (1/-)62.1 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 1.00 [0.02, 50.59]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 1.00 [0.14, 7.15]< 10%1 study (1/-)50.0 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Alopecia AE (grade 3-4) 0.50 [0.04, 5.53]< 10%1 study (1/-)71.3 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.67 [0.41, 1.07]< 10%1 study (1/-)95.3 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 1.68 [0.40, 7.10]< 10%1 study (1/-)24.1 %NAnot evaluable non important-
Back pain AE (grade 3-4) 0.50 [0.02, 14.94]< 10%1 study (1/-)65.4 %NAnot evaluable non important-
Constipation AE (grade 3-4) 2.00 [0.07, 59.99]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Cough AE (grade 3-4) 2.00 [0.07, 59.99]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 2.53 [0.49, 13.15]< 10%1 study (1/-)13.6 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 2.37 [0.61, 9.26]< 10%1 study (1/-)10.8 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 1.51 [0.42, 5.42]< 10%1 study (1/-)26.3 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 1.00 [0.20, 5.00]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
Febrile neutropenia AE (grade 3-4) 0.81 [0.39, 1.69]< 10%1 study (1/-)71.0 %NAnot evaluable non important-
Headache AE (grade 3-4) 2.00 [0.07, 59.99]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 7.16 [0.88, 58.62]< 10%1 study (1/-)3.4 %NAnot evaluable non important-
Hyperthyroidism AE (grade 3-4) 2.00 [0.07, 59.99]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Increased Lipase Level AE (grade 3-4) 1.51 [0.42, 5.42]< 10%1 study (1/-)26.3 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 0.92 [0.43, 2.01]< 10%1 study (1/-)57.8 %NAnot evaluable non important-
Nausea AE (grade 3-4) 1.00 [0.29, 3.50]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 0.95 [0.66, 1.37]< 10%1 study (1/-)60.9 %NAnot evaluable non important-
Pneumonia AE (grade 3-4) 1.00 [0.39, 2.56]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 1.00 [0.02, 50.59]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 0.50 [0.02, 14.94]< 10%1 study (1/-)65.4 %NAnot evaluable non important-
Rash AE (grade 3-4) 6.06 [0.30, 121.51]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.96 [0.53, 1.72]< 10%1 study (1/-)56.0 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 1.34 [0.30, 6.04]< 10%1 study (1/-)35.3 %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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