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melanoma (ML), ipilimumab alone versus ipilimumab 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) 1.19 [1.00, 1.42]< 10%1 study (1/-)2.4 %NAnot evaluable crucial-
progression or deaths (PFS) 1.12 [0.83, 1.52]< 10%1 study (1/-)22.7 %NAnot evaluable important-
DCR 0.84 [0.61, 1.16]> 10%1 study (1/-)14.4 %NAnot evaluable non important-
objective responses (ORR) 0.76 [0.50, 1.17]> 10%1 study (1/-)10.7 %NAnot evaluable non important-

safety endpoints 00

TRAE (any grade) 0.42 [0.31, 0.57]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.37 [0.25, 0.54]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.50 [0.09, 2.75]< 10%1 study (1/-)78.7 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.51 [0.36, 0.72]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 0.44 [0.30, 0.66]< 10%1 study (1/-)100.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 0.50 [0.02, 15.01]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.46 [0.21, 1.04]< 10%1 study (1/-)96.9 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.54 [0.31, 0.95]< 10%1 study (1/-)98.4 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 0.43 [0.19, 1.01]< 10%1 study (1/-)97.3 %NAnot evaluable non important-
Eye disorders TRAE (grade 3-4) 2.01 [0.07, 60.22]< 10%1 study (1/-)34.5 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.25 [0.01, 5.57]< 10%1 study (1/-)80.6 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 0.55 [0.34, 0.88]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
Guillain-Barré syndrome TRAE (grade 3-4) 0.25 [0.01, 5.57]< 10%1 study (1/-)80.6 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 0.40 [0.08, 2.07]< 10%1 study (1/-)86.2 %NAnot evaluable non important-
Hypersensitivity TRAE (grade 3-4) 0.17 [0.01, 3.33]< 10%1 study (1/-)87.7 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 0.70 [0.26, 1.85]< 10%1 study (1/-)76.4 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.50 [0.02, 15.01]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.12 [0.02, 0.99]< 10%1 study (1/-)97.5 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.16 [0.04, 0.73]< 10%1 study (1/-)99.1 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 0.50 [0.02, 15.01]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 0.25 [0.01, 5.57]< 10%1 study (1/-)80.6 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 0.50 [0.02, 15.01]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Nervous system disorders TRAE (grade 3-4) 0.12 [0.01, 2.36]< 10%1 study (1/-)91.5 %NAnot evaluable non important-
Pancreatitis TRAE (grade 3-4) 0.50 [0.02, 15.01]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Pancytopenia TRAE (grade 3-4) 0.50 [0.02, 15.01]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Pericarditis TRAE (grade 3-4) 0.50 [0.02, 15.01]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 0.25 [0.01, 5.57]< 10%1 study (1/-)80.6 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 0.12 [0.01, 2.36]< 10%1 study (1/-)91.5 %NAnot evaluable non important-
Polymyalgia Rheumatica TRAE (grade 3-4) 2.01 [0.07, 60.22]< 10%1 study (1/-)34.5 %NAnot evaluable non important-
Pruritic rash TRAE (grade 3-4) 2.01 [0.07, 60.22]< 10%1 study (1/-)34.5 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 1.01 [0.14, 7.18]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.40 [0.08, 2.07]< 10%1 study (1/-)86.2 %NAnot evaluable non important-
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) 0.12 [0.01, 2.36]< 10%1 study (1/-)91.5 %NAnot evaluable non important-
Skin and subcutaneous tissue disorders TRAE (grade 3-4) 0.71 [0.22, 2.27]< 10%1 study (1/-)71.5 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 0.50 [0.02, 15.01]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Uveitis TRAE (grade 3-4) 2.01 [0.07, 60.22]< 10%1 study (1/-)34.5 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

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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