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metastatic/adv melanoma (mML), ipilimumab alone versus Immunostimulant, 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) 0.66 [0.51, 0.86]< 10%1 study (1/-)99.9 %NAnot evaluable crucial-
objective responses (ORR) 8.24 [1.85, 36.76]> 10%1 study (1/-)99.7 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.99 [0.24, 4.05]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
AE (grade 3-4) 0.95 [0.59, 1.55]< 10%1 study (1/-)57.5 %NAnot evaluable non important-
TRAE (any grade) 1.09 [0.60, 1.98]< 10%1 study (1/-)39.2 %NAnot evaluable non important-
TRAE (grade 3-4) 1.41 [0.69, 2.88]< 10%1 study (1/-)17.7 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 1.01 [0.02, 51.17]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 14.85 [0.83, 264.38]< 10%1 study (1/-)3.5 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 6.29 [0.75, 52.98]< 10%1 study (1/-)4.6 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 10.44 [0.56, 193.00]< 10%1 study (1/-)6.0 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 10.83 [1.37, 85.84]< 10%1 study (1/-)1.2 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 1.01 [0.02, 51.17]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Hepatobiliary disorders TRAE (grade 3-4) 0.16 [0.01, 3.32]< 10%1 study (1/-)87.8 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 4.08 [0.18, 91.29]< 10%1 study (1/-)19.1 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.01 [0.02, 51.17]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 1.01 [0.02, 51.17]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 1.01 [0.02, 51.17]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 1.01 [0.02, 51.17]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 2.02 [0.07, 60.83]< 10%1 study (1/-)34.5 %NAnot evaluable non important-
Skin and subcutaneous tissue disorders TRAE (grade 3-4) 4.08 [0.18, 91.29]< 10%1 study (1/-)19.1 %NAnot evaluable non important-
Vitiligo TRAE (grade 3-4) 1.01 [0.02, 51.17]< 10%1 study (1/-)49.9 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Abdominal pain AE (grade 3-4) 0.28 [0.06, 1.36]< 10%1 study (1/-)94.3 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.35 [0.11, 1.12]< 10%1 study (1/-)96.2 %NAnot evaluable non important-
Constipation AE (grade 3-4) 3.07 [0.32, 29.91]< 10%1 study (1/-)16.9 %NAnot evaluable non important-
Cough AE (grade 3-4) 1.01 [0.02, 51.17]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.50 [0.09, 2.76]< 10%1 study (1/-)78.8 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 7.40 [0.90, 60.98]< 10%1 study (1/-)3.2 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 0.83 [0.25, 2.80]< 10%1 study (1/-)61.6 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 2.36 [0.71, 7.87]< 10%1 study (1/-)8.1 %NAnot evaluable non important-
Headache AE (grade 3-4) 1.01 [0.20, 5.09]< 10%1 study (1/-)49.6 %NAnot evaluable non important-
Nausea AE (grade 3-4) 1.01 [0.20, 5.09]< 10%1 study (1/-)49.6 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 0.25 [0.01, 5.58]< 10%1 study (1/-)80.7 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 1.01 [0.20, 5.09]< 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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