pdf   xlsx method abbreviations

locally advanced NSCLC - maintenance (M), 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) 0.68 [0.47, 0.99]< 10%1 study (1/-)97.8 %NAnot evaluable crucial-
deaths (OS) (extension) 0.72 [0.59, 0.88]< 10%1 study (1/-)99.9 %NAnot evaluable important-
PFS (extension) 0.55 [0.45, 0.68]< 10%1 study (1/-)100.0 %NAnot evaluable important-
progression or deaths (PFS) 0.52 [0.42, 0.65]< 10%1 study (1/-)100.0 %NAnot evaluable important-
objective responses (ORR) 2.03 [1.36, 3.03]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 1.66 [0.76, 3.60]< 10%1 study (1/-)10.1 %NAnot evaluable non important-
AE (grade 3-4) 1.21 [0.85, 1.72]< 10%1 study (1/-)14.5 %NAnot evaluable non important-
AE leading to death (grade 5) 0.79 [0.39, 1.60]< 10%1 study (1/-)74.6 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 1.67 [1.01, 2.74]< 10%1 study (1/-)2.2 %NAnot evaluable non important-
SAE (any grade) 1.37 [0.95, 1.97]< 10%1 study (1/-)4.6 %NAnot evaluable non important-
TRAE (any grade) 1.84 [1.33, 2.53]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE (grade 3-4) 2.99 [1.50, 5.98]< 10%1 study (1/-)0.1 %NAnot evaluable non important-
TRAE leading to death (grade 5) 1.15 [0.30, 4.49]< 10%1 study (1/-)42.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Asthenia TRAE (grade 3-4) 2.97 [0.15, 59.50]< 10%1 study (1/-)24.1 %NAnot evaluable non important-
Cough TRAE (grade 3-4) 0.49 [0.01, 24.88]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.25 [0.01, 7.35]< 10%1 study (1/-)78.8 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.49 [0.07, 3.50]< 10%1 study (1/-)76.0 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 2.97 [0.15, 59.50]< 10%1 study (1/-)24.1 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.49 [0.01, 24.88]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.99 [0.03, 29.48]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.49 [0.01, 24.88]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 0.65 [0.22, 1.90]< 10%1 study (1/-)78.4 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.49 [0.01, 24.88]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.99 [0.03, 29.48]< 10%1 study (1/-)50.3 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Anaemia AE (grade 3-4) 0.86 [0.35, 2.07]< 10%1 study (1/-)63.3 %NAnot evaluable non important-
Arthralgia AE (grade 3-4) 0.49 [0.01, 24.88]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 1.48 [0.15, 14.32]< 10%1 study (1/-)36.8 %NAnot evaluable non important-
Back pain AE (grade 3-4) 0.49 [0.03, 7.89]< 10%1 study (1/-)69.0 %NAnot evaluable non important-
Constipation AE (grade 3-4) 0.99 [0.03, 29.48]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Cough AE (grade 3-4) 0.99 [0.09, 10.92]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.24 [0.02, 2.71]< 10%1 study (1/-)87.3 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 0.49 [0.10, 2.44]< 10%1 study (1/-)80.7 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 0.57 [0.19, 1.71]< 10%1 study (1/-)84.2 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.16 [0.02, 1.57]< 10%1 study (1/-)94.1 %NAnot evaluable non important-
Headache AE (grade 3-4) 0.24 [0.02, 2.71]< 10%1 study (1/-)87.3 %NAnot evaluable non important-
Hypothyroidism AE (grade 3-4) 0.99 [0.03, 29.48]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.49 [0.01, 24.88]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Pneumonia AE (grade 3-4) 1.16 [0.52, 2.57]< 10%1 study (1/-)36.1 %NAnot evaluable non important-
Pneumonitis AE (grade 3-4) 1.32 [0.51, 3.43]< 10%1 study (1/-)28.2 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 0.49 [0.01, 24.88]< 10%1 study (1/-)63.6 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 0.99 [0.03, 29.48]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Rash AE (grade 3-4) 0.99 [0.03, 29.48]< 10%1 study (1/-)50.3 %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.