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melanoma (ML), nivolumab based treatment versus non platinum-based chemotherapy, 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) 0.38 [0.28, 0.53]< 10%2 studies (2/-)100.0 %lownot evaluable highcrucial-
deaths (OS) (extension) 0.46 [0.36, 0.59]< 10%1 study (1/-)100.0 %NAnot evaluable important-
PFS (extension) 0.42 [0.33, 0.53]< 10%1 study (1/-)100.0 %NAnot evaluable important-
progression or deaths (PFS) 0.43 [0.36, 0.51]< 10%2 studies (2/-)100.0 %lownot evaluable highimportant-
DOR (extension) 3.45 [1.46, 8.18]> 10%1 study (1/-)99.8 %NAnot evaluable non important-
objective responses (ORR) 4.06 [2.90, 5.69]> 10%2 studies (2/-)100.0 %lownot evaluable highnon important-
objective responses (ORR) (extension) 4.50 [2.79, 7.25]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.78 [0.34, 1.76]< 10%1 study (1/-)72.7 %NAnot evaluable non important-
AE (grade 3-4) 0.84 [0.56, 1.25]< 10%1 study (1/-)80.5 %NAnot evaluable non important-
AE leading to death (grade 5) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.55 [0.28, 1.10]< 10%1 study (1/-)95.5 %NAnot evaluable non important-
AE leading to treatment discontinuation (grade 3-4) 0.61 [0.29, 1.28]< 10%1 study (1/-)90.5 %NAnot evaluable non important-
SAE (any grade) 0.73 [0.49, 1.10]< 10%1 study (1/-)93.1 %NAnot evaluable non important-
SAE (grade 3-4) 0.74 [0.47, 1.17]< 10%1 study (1/-)90.4 %NAnot evaluable non important-
STRAE (any grade) 1.06 [0.54, 2.07]< 10%1 study (1/-)43.8 %NAnot evaluable non important-
STRAE (grade 3-4) 0.99 [0.44, 2.27]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
TRAE (any grade) 0.93 [0.60, 1.46]< 10%1 study (1/-)62.3 %NAnot evaluable non important-
TRAE (grade 3-4) 0.62 [0.35, 1.08]< 10%1 study (1/-)95.4 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Abdominal pain TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Arthralgia TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.50 [0.02, 14.88]< 10%1 study (1/-)65.5 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Cough TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 2.00 [0.18, 22.23]< 10%1 study (1/-)28.8 %NAnot evaluable non important-
Dry skin TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.25 [0.01, 5.51]< 10%1 study (1/-)80.8 %NAnot evaluable non important-
Headache TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Hypersensitivity TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 2.00 [0.07, 59.80]< 10%1 study (1/-)34.7 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 1.00 [0.06, 16.02]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 2.00 [0.18, 22.23]< 10%1 study (1/-)28.8 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.12 [0.01, 2.33]< 10%1 study (1/-)91.7 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 2.00 [0.07, 59.80]< 10%1 study (1/-)34.7 %NAnot evaluable non important-
Myalgia TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.05 [0.00, 0.92]< 10%1 study (1/-)97.7 %NAnot evaluable non important-
Pancytopenia TRAE (grade 3-4) 0.16 [0.01, 3.29]< 10%1 study (1/-)87.9 %NAnot evaluable non important-
Paraesthesia TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 2.00 [0.07, 59.80]< 10%1 study (1/-)34.7 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.50 [0.02, 14.88]< 10%1 study (1/-)65.5 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 2.00 [0.07, 59.80]< 10%1 study (1/-)34.7 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.05 [0.00, 0.82]< 10%1 study (1/-)98.1 %NAnot evaluable non important-
Vitiligo TRAE (grade 3-4) 1.00 [0.02, 50.40]< 10%1 study (1/-)50.1 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 1.00 [0.06, 16.02]< 10%1 study (1/-)50.1 %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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