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mML - 1st line (L1), anti-CTLA-4 , 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) 0.69 [0.54, 0.89]< 171%4 studies (4/-)99.8 %lownot evaluable highcrucial-
objective responses (ORR) 4.30 [1.52, 12.14]> 193%4 studies (4/-)99.7 %lownot evaluable highnon important-

safety endpoints 00

AE (any grade) 2.22 [1.12, 4.38]< 10%1 study (1/-)1.1 %NAnot evaluable non important-
AE (grade 3-4) 1.84 [1.35, 2.52]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
AE leading to death (grade 5) 1.71 [0.85, 3.45]< 10%1 study (1/-)6.8 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 97.13 [5.95, 1585.40]< 10%1 study (1/-)0.1 %NAnot evaluable non important-
SAE (any grade) 3.19 [2.19, 4.65]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 3.44 [0.64, 18.34]< 10%3 studies (3/-)7.5 %some concernnot evaluable moderatenon important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 1.99 [0.44, 8.99]< 134%4 studies (4/-)18.6 %lownot evaluable highnon important-
Eye disorders TRAE (grade 3-4) 0.98 [0.02, 49.62]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 3.86 [0.79, 18.86]< 10%4 studies (4/-)4.8 %lownot evaluable highnon important-
Pancreatitis TRAE (grade 3-4) 5.93 [0.30, 118.96]< 10%1 study (1/-)12.5 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Abdominal pain AE (grade 3-4) 4.04 [1.13, 14.45]< 10%1 study (1/-)1.6 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.10 [0.01, 1.78]< 10%1 study (1/-)94.0 %NAnot evaluable non important-
Constipation AE (grade 3-4) 0.98 [0.14, 7.01]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Cough AE (grade 3-4) 1.97 [0.07, 58.81]< 10%1 study (1/-)35.0 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 14.32 [1.87, 109.52]< 10%1 study (1/-)0.5 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 4.00 [0.84, 18.98]< 10%1 study (1/-)4.1 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 3.90 [1.44, 10.57]< 10%1 study (1/-)0.4 %NAnot evaluable non important-
Headache AE (grade 3-4) 1.97 [0.18, 21.82]< 10%1 study (1/-)29.2 %NAnot evaluable non important-
Nausea AE (grade 3-4) 1.39 [0.61, 3.18]< 10%1 study (1/-)21.7 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 0.03 [0.00, 0.19]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Peripheral oedema AE (grade 3-4) 4.97 [0.58, 42.77]< 10%1 study (1/-)7.3 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 5.93 [0.30, 118.96]< 10%1 study (1/-)12.5 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 7.94 [0.42, 150.76]< 10%1 study (1/-)8.6 %NAnot evaluable non important-
Rash AE (grade 3-4) 7.00 [0.86, 57.23]< 10%1 study (1/-)3.6 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.03 [0.00, 0.26]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 1.55 [0.66, 3.64]< 10%1 study (1/-)15.7 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 0.98 [0.06, 15.76]< 10%1 study (1/-)50.5 %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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