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melanoma (ML), ipilimumab 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) 0.72 [0.59, 0.87]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
deaths (OS) (extension) 0.69 [0.57, 0.84]< 10%1 study (1/-)100.0 %NAnot evaluable important-
progression or deaths (PFS) 0.76 [0.63, 0.92]< 10%1 study (1/-)99.7 %NAnot evaluable important-
DCR 1.15 [0.79, 1.68]> 10%1 study (1/-)76.8 %NAnot evaluable non important-
objective responses (ORR) 1.56 [0.91, 2.65]> 10%1 study (1/-)94.8 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 5.17 [1.48, 18.09]< 10%1 study (1/-)0.5 %NAnot evaluable non important-
AE (grade 3-4) 3.39 [2.34, 4.94]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
AE leading to death (grade 5) 1.02 [0.02, 51.42]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
TRAE (any grade) 5.64 [3.80, 8.35]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE (grade 3-4) 11.25 [6.30, 20.10]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Colitis TRAE (grade 3-4) 10.35 [0.56, 190.49]< 10%1 study (1/-)6.0 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 21.14 [1.23, 363.94]< 10%1 study (1/-)1.9 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 6.16 [0.31, 123.62]< 10%1 study (1/-)12.0 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.02 [0.02, 51.42]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.02 [0.02, 51.42]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 52.70 [7.19, 385.99]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 32.40 [7.79, 134.72]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 10.35 [0.56, 190.49]< 10%1 study (1/-)6.0 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 6.16 [0.31, 123.62]< 10%1 study (1/-)12.0 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 1.02 [0.02, 51.42]< 10%1 study (1/-)49.7 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Abdominal pain AE (grade 3-4) 0.43 [0.11, 1.68]< 10%1 study (1/-)88.8 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.17 [0.02, 1.39]< 10%1 study (1/-)95.0 %NAnot evaluable non important-
Chills AE (grade 3-4) 1.02 [0.02, 51.42]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
Constipation AE (grade 3-4) 1.02 [0.02, 51.42]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
Cough AE (grade 3-4) 2.04 [0.07, 60.99]< 10%1 study (1/-)34.3 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.76 [0.17, 3.43]< 10%1 study (1/-)63.9 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 21.14 [1.23, 363.94]< 10%1 study (1/-)1.9 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 16.77 [0.96, 293.61]< 10%1 study (1/-)2.8 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 2.44 [1.21, 4.94]< 10%1 study (1/-)0.6 %NAnot evaluable non important-
Headache AE (grade 3-4) 4.12 [0.46, 37.08]< 10%1 study (1/-)10.5 %NAnot evaluable non important-
Increase AST AE (grade 3-4) 18.42 [5.64, 60.14]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Increased ALT AE (grade 3-4) 34.83 [8.39, 144.67]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Nausea AE (grade 3-4) 1.36 [0.30, 6.14]< 10%1 study (1/-)34.5 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 10.35 [0.56, 190.49]< 10%1 study (1/-)6.0 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 1.02 [0.02, 51.42]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
Rash AE (grade 3-4) 6.16 [0.31, 123.62]< 10%1 study (1/-)12.0 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 2.07 [0.61, 6.95]< 10%1 study (1/-)12.1 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 1.02 [0.06, 16.34]< 10%1 study (1/-)49.6 %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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