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melanoma (ML), anti-PD-(L)1 versus placebo 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) 0.83 [0.65, 1.07]< 10%2 studies (2/-)92.2 %lownot evaluable highcrucial-
progression or deaths (PFS) 0.76 [0.62, 0.93]< 10%2 studies (2/-)99.7 %lownot evaluable highimportant-
DOR 0.41 [0.20, 0.83]< 10%1 study (1/-)99.3 %NAnot evaluable non important-
objective responses (ORR) 1.00 [0.61, 1.66]> 139%2 studies (2/-)50.7 %lownot evaluable highnon important-

safety endpoints 00

AE (any grade) 2.03 [0.18, 23.06]< 10%1 study (1/-)28.5 %NAnot evaluable non important-
AE (grade 3-4) 2.44 [1.17, 5.12]< 10%1 study (1/-)0.9 %NAnot evaluable non important-
AE leading to death (grade 5) 1.39 [0.51, 3.81]< 10%2 studies (2/-)26.0 %lownot evaluable highnon important-
AE leading to treatment discontinuation (any grade) 1.36 [0.42, 4.40]< 184%2 studies (2/-)30.5 %lownot evaluable highnon important-
STRAE (any grade) 1.24 [0.85, 1.81]< 10%1 study (1/-)12.9 %NAnot evaluable non important-
TRAE (any grade) 1.12 [0.33, 3.77]< 10%2 studies (2/-)42.8 %lownot evaluable highnon important-
TRAE (grade 3-4) 2.12 [0.85, 5.29]< 178%2 studies (2/-)5.3 %lownot evaluable highnon important-
TRAE leading to death (grade 5) 2.02 [0.07, 61.28]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 2.67 [1.18, 6.03]< 10%1 study (1/-)0.9 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Arthralgia TRAE (grade 3-4) 1.44 [0.48, 4.34]< 10%1 study (1/-)26.0 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 2.47 [0.45, 13.60]< 10%1 study (1/-)15.1 %NAnot evaluable non important-
Blood creatinine increased TRAE (grade 3-4) 0.61 [0.02, 18.27]< 10%1 study (1/-)61.1 %NAnot evaluable non important-
Chorioretinopathy TRAE (grade 3-4) 0.61 [0.02, 18.27]< 10%1 study (1/-)61.1 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.30 [0.01, 6.77]< 10%1 study (1/-)77.1 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.53 [0.16, 1.76]< 10%1 study (1/-)84.8 %NAnot evaluable non important-
Dry skin TRAE (grade 3-4) 4.92 [0.22, 109.67]< 10%1 study (1/-)16.0 %NAnot evaluable non important-
Erythema TRAE (grade 3-4) 7.41 [0.37, 148.78]< 10%1 study (1/-)9.8 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 3.70 [0.38, 35.82]< 10%1 study (1/-)13.1 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 4.92 [0.22, 109.67]< 10%1 study (1/-)16.0 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 0.99 [0.64, 1.52]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 1.36 [0.78, 2.37]< 10%1 study (1/-)14.1 %NAnot evaluable non important-
Myalgia TRAE (grade 3-4) 2.46 [0.22, 27.26]< 10%1 study (1/-)23.4 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.17 [0.02, 1.40]< 10%1 study (1/-)94.9 %NAnot evaluable non important-
Peripheral oedema TRAE (grade 3-4) 1.22 [0.02, 61.84]< 10%1 study (1/-)46.1 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 4.92 [0.22, 109.67]< 10%1 study (1/-)16.0 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 2.46 [0.22, 27.26]< 10%1 study (1/-)23.4 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 1.22 [0.24, 6.13]< 10%1 study (1/-)40.3 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.98 [0.53, 1.81]< 10%1 study (1/-)53.2 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.48 [0.09, 2.52]< 10%1 study (1/-)80.5 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Hypothyroidism AE (grade 3-4) 1.22 [0.02, 61.84]< 10%1 study (1/-)46.1 %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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