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melanoma (ML), ipilimumab plus gp100 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) 1.04 [0.83, 1.30]< 10%1 study (1/-)36.6 %NAnot evaluable crucial-
objective responses (ORR) 0.49 [0.25, 0.97]> 10%1 study (1/-)2.1 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 1.96 [0.55, 7.07]< 10%1 study (1/-)15.2 %NAnot evaluable non important-
AE (grade 3-4) 0.99 [0.66, 1.47]< 10%1 study (1/-)52.2 %NAnot evaluable non important-
TRAE (any grade) 1.99 [1.17, 3.41]< 10%1 study (1/-)0.6 %NAnot evaluable non important-
TRAE (grade 3-4) 1.17 [0.68, 2.01]< 10%1 study (1/-)29.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 1.38 [0.06, 30.82]< 10%1 study (1/-)42.0 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.58 [0.22, 1.50]< 10%1 study (1/-)87.0 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.80 [0.30, 2.12]< 10%1 study (1/-)67.5 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 0.27 [0.07, 1.01]< 10%1 study (1/-)97.4 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 0.74 [0.34, 1.61]< 10%1 study (1/-)77.3 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 0.69 [0.02, 20.65]< 10%1 study (1/-)58.4 %NAnot evaluable non important-
Hepatobiliary disorders TRAE (grade 3-4) 2.78 [0.15, 52.88]< 10%1 study (1/-)25.1 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 0.34 [0.05, 2.45]< 10%1 study (1/-)85.6 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.69 [0.02, 20.65]< 10%1 study (1/-)58.4 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.69 [0.02, 20.65]< 10%1 study (1/-)58.4 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 1.38 [0.06, 30.82]< 10%1 study (1/-)42.0 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.69 [0.02, 20.65]< 10%1 study (1/-)58.4 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 1.73 [0.20, 14.97]< 10%1 study (1/-)31.0 %NAnot evaluable non important-
Skin and subcutaneous tissue disorders TRAE (grade 3-4) 1.56 [0.33, 7.34]< 10%1 study (1/-)28.6 %NAnot evaluable non important-
Vitiligo TRAE (grade 3-4) 0.34 [0.01, 17.42]< 10%1 study (1/-)69.9 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Abdominal pain AE (grade 3-4) 1.03 [0.21, 5.19]< 10%1 study (1/-)48.3 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.95 [0.30, 3.03]< 10%1 study (1/-)53.7 %NAnot evaluable non important-
Constipation AE (grade 3-4) 0.34 [0.07, 1.70]< 10%1 study (1/-)90.5 %NAnot evaluable non important-
Cough AE (grade 3-4) 0.69 [0.02, 20.65]< 10%1 study (1/-)58.4 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 1.03 [0.21, 5.19]< 10%1 study (1/-)48.3 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 0.83 [0.34, 2.05]< 10%1 study (1/-)65.7 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 0.96 [0.34, 2.73]< 10%1 study (1/-)52.8 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.71 [0.31, 1.62]< 10%1 study (1/-)79.0 %NAnot evaluable non important-
Headache AE (grade 3-4) 0.45 [0.10, 2.06]< 10%1 study (1/-)84.7 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.68 [0.17, 2.78]< 10%1 study (1/-)70.2 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 1.38 [0.06, 30.82]< 10%1 study (1/-)42.0 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.80 [0.20, 3.14]< 10%1 study (1/-)62.5 %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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