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melanoma (ML), ipilimumab based treatment versus placebo, 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 [0.58, 0.89]< 10%1 study (1/-)99.9 %NAnot evaluable crucial-
deaths (OS) (extension) 0.73 [0.64, 0.83]< 10%1 study (1/-)100.0 %NAnot evaluable important-
MFS 0.76 [0.63, 0.91]< 10%1 study (1/-)99.8 %NAnot evaluable important-
MFS (extension) 0.76 [0.64, 0.90]< 10%1 study (1/-)99.9 %NAnot evaluable important-
RFS (extension) 0.75 [0.63, 0.89]< 10%1 study (1/-)100.0 %NAnot evaluable important-
RFS/DFS 0.75 [0.63, 0.89]< 10%1 study (1/-)100.0 %NAnot evaluable important-

safety endpoints 00

AE (any grade) 7.53 [3.17, 17.90]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
AE (grade 3-4) 0.11 [0.08, 0.17]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (any grade) 14.40 [10.07, 20.60]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE (grade 3-4) 25.27 [14.14, 45.18]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 10.16 [0.55, 186.52]< 10%1 study (1/-)6.1 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 21.35 [13.41, 33.97]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Colitis TRAE (grade 3-4) 39.14 [5.34, 286.74]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 25.54 [6.16, 105.87]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 42.70 [5.84, 312.15]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 22.61 [8.20, 62.34]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Hepatobiliary disorders TRAE (grade 3-4) 57.44 [7.90, 417.44]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 44.19 [2.67, 732.31]< 10%1 study (1/-)0.4 %NAnot evaluable non important-
Nervous system disorders TRAE (grade 3-4) 18.45 [1.07, 319.15]< 10%1 study (1/-)2.4 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 10.16 [0.55, 186.52]< 10%1 study (1/-)6.1 %NAnot evaluable non important-
Skin and subcutaneous tissue disorders TRAE (grade 3-4) 42.00 [2.53, 697.02]< 10%1 study (1/-)0.5 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Abdominal pain AE (grade 3-4) 0.04 [0.01, 0.17]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Colitis AE (grade 3-4) 6.26 [2.61, 15.03]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Cough AE (grade 3-4) 0.01 [0.00, 0.15]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.06 [0.01, 0.46]< 10%1 study (1/-)99.6 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 0.26 [0.18, 0.37]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.05 [0.03, 0.10]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Headache AE (grade 3-4) 0.04 [0.01, 0.11]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Hypophysitis AE (grade 3-4) 11.01 [2.57, 47.24]< 10%1 study (1/-)0.1 %NAnot evaluable non important-
Hypothyroidism AE (grade 3-4) 0.14 [0.02, 1.16]< 10%1 study (1/-)96.5 %NAnot evaluable non important-
Increase AST AE (grade 3-4) 0.80 [0.45, 1.45]< 10%1 study (1/-)76.6 %NAnot evaluable non important-
Increased ALT AE (grade 3-4) 0.97 [0.55, 1.70]< 10%1 study (1/-)54.8 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.01 [0.00, 0.07]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 0.14 [0.07, 0.26]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 0.21 [0.08, 0.56]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Rash AE (grade 3-4) 0.06 [0.03, 0.15]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.07 [0.02, 0.29]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 0.02 [0.00, 0.16]< 10%1 study (1/-)100.0 %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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