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mML - (neo)adjuvant (NA), nivolumab based treatment versus ipilimumab alone, 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) 0.87 [0.66, 1.14]< 10%1 study (1/-)84.1 %NAnot evaluable crucial-
MFS 0.73 [0.56, 0.96]< 10%1 study (1/-)98.8 %NAnot evaluable important-
RFS (extension) 0.71 [0.59, 0.85]< 10%1 study (1/-)100.0 %NAnot evaluable important-
RFS/DFS 0.65 [0.51, 0.83]< 10%1 study (1/-)100.0 %NAnot evaluable important-

safety endpoints 00

AE (any grade) 0.49 [0.20, 1.23]< 10%1 study (1/-)93.6 %NAnot evaluable non important-
AE (grade 3-4) 0.28 [0.21, 0.37]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.15 [0.10, 0.21]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
AE leading to treatment discontinuation (grade 3-4) 0.11 [0.07, 0.18]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (any grade) 0.25 [0.15, 0.43]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.20 [0.14, 0.27]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.25 [0.01, 5.55]< 10%1 study (1/-)80.7 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.12 [0.08, 0.17]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 0.09 [0.05, 0.15]< 10%1 study (1/-)100.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Abdominal pain TRAE (grade 3-4) 0.50 [0.02, 14.96]< 10%1 study (1/-)65.3 %NAnot evaluable non important-
Adrenal insufficiency TRAE (grade 3-4) 0.50 [0.09, 2.74]< 10%1 study (1/-)78.7 %NAnot evaluable non important-
Arthralgia TRAE (grade 3-4) 0.50 [0.05, 5.53]< 10%1 study (1/-)71.3 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.25 [0.03, 2.24]< 10%1 study (1/-)89.1 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 2.01 [0.07, 59.97]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.15 [0.07, 0.34]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.50 [0.09, 2.74]< 10%1 study (1/-)78.7 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 0.10 [0.05, 0.20]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Headache TRAE (grade 3-4) 0.14 [0.02, 1.15]< 10%1 study (1/-)96.5 %NAnot evaluable non important-
Hepatobiliary disorders TRAE (grade 3-4) 0.15 [0.07, 0.32]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Hypersensitivity TRAE (grade 3-4) 2.01 [0.07, 59.97]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.00 [0.06, 16.07]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 0.18 [0.04, 0.81]< 10%1 study (1/-)98.7 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.50 [0.05, 5.53]< 10%1 study (1/-)71.3 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.10 [0.02, 0.44]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.18 [0.07, 0.48]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 0.05 [0.00, 0.95]< 10%1 study (1/-)97.6 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 2.01 [0.07, 59.97]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.10 [0.01, 1.82]< 10%1 study (1/-)93.8 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.25 [0.01, 5.55]< 10%1 study (1/-)80.7 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.35 [0.13, 0.98]< 10%1 study (1/-)97.7 %NAnot evaluable non important-
Renal and urinary disorders TRAE (grade 3-4) 1.00 [0.02, 50.62]< 10%1 study (1/-)50.0 %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) 0.18 [0.07, 0.46]< 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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