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mUC - L1 - all population, pembrolizumab 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) 0.89 [0.78, 1.01]< 10%2 studies (2/-)96.8 %some concernnot evaluable moderatecrucial-
progression or deaths (PFS) 1.03 [0.60, 1.76]< 194%2 studies (2/-)46.3 %some concernnot evaluable moderateimportant-
objective responses (ORR) 0.89 [0.33, 2.43]> 195%2 studies (2/-)41.1 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE (grade 3-5) 0.76 [0.19, 3.00]< 196%2 studies (2/-)65.4 %some concernnot evaluable moderatenon important-
AE leading to death (grade 5) 3.61 [2.10, 6.20]< 10%2 studies (2/-)0.0 %some concernnot evaluable moderatenon important-
AE leading to treatment discontinuation (any grade) 1.32 [0.57, 3.08]< 190%2 studies (2/-)25.9 %some concernnot evaluable moderatenon important-
STRAE (any grade) 0.68 [0.23, 1.96]< 194%2 studies (2/-)76.3 %some concernnot evaluable moderatenon important-
TRAE (any grade) 0.08 [0.04, 0.14]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.31 [0.02, 4.36]< 199%2 studies (2/-)80.5 %some concernnot evaluable moderatenon important-
TRAE leading to death (grade 5) 1.05 [0.26, 4.23]< 10%2 studies (2/-)47.1 %some concernnot evaluable moderatenon important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 1.55 [0.12, 20.23]< 10%2 studies (2/-)37.0 %some concernnot evaluable moderatenon important-
Anaemia TRAE (grade 3-4) 0.14 [0.00, 5.49]< 197%2 studies (2/-)84.9 %some concernnot evaluable moderatenon important-
Asthenia TRAE (grade 3-4) 0.43 [0.06, 3.14]< 169%2 studies (2/-)79.6 %some concernnot evaluable moderatenon important-
Colitis TRAE (grade 3-4) 3.12 [0.62, 15.78]< 10%2 studies (2/-)8.6 %some concernnot evaluable moderatenon important-
Constipation TRAE (grade 3-4) 0.73 [0.14, 3.84]< 10%2 studies (2/-)64.4 %some concernnot evaluable moderatenon important-
Decreased appetite TRAE (grade 3-4) 0.35 [0.07, 1.74]< 10%2 studies (2/-)90.0 %some concernnot evaluable moderatenon important-
Diabetes TRAE (grade 3-4) 2.11 [0.19, 23.33]< 10%2 studies (2/-)27.3 %some concernnot evaluable moderatenon important-
Diarrhoea TRAE (grade 3-4) 1.15 [0.48, 2.75]< 10%2 studies (2/-)37.7 %some concernnot evaluable moderatenon important-
Fatigue TRAE (grade 3-4) 0.70 [0.33, 1.47]< 10%2 studies (2/-)82.9 %some concernnot evaluable moderatenon important-
Hepatitis TRAE (grade 3-4) 2.11 [0.19, 23.33]< 10%2 studies (2/-)27.3 %some concernnot evaluable moderatenon important-
Hyperthyroidism TRAE (grade 3-4) 1.55 [0.12, 20.23]< 10%2 studies (2/-)37.0 %some concernnot evaluable moderatenon important-
Hypophysitis TRAE (grade 3-4) 3.89 [0.41, 36.85]< 10%2 studies (2/-)12.0 %some concernnot evaluable moderatenon important-
Hypothyroidism TRAE (grade 3-4) 3.06 [0.31, 30.30]< 10%2 studies (2/-)17.1 %some concernnot evaluable moderatenon important-
Leucopenia TRAE (grade 3-4) 0.09 [0.00, 7.03]< 189%2 studies (2/-)85.4 %some concernnot evaluable moderatenon important-
Myocarditis TRAE (grade 3-4) 1.55 [0.12, 20.23]< 10%2 studies (2/-)37.0 %some concernnot evaluable moderatenon important-
Myositis TRAE (grade 3-4) 1.05 [0.07, 16.88]< 10%2 studies (2/-)48.5 %some concernnot evaluable moderatenon important-
Nausea TRAE (grade 3-4) 0.57 [0.20, 1.64]< 128%2 studies (2/-)85.0 %some concernnot evaluable moderatenon important-
Nephritis TRAE (grade 3-4) 2.11 [0.19, 23.33]< 10%2 studies (2/-)27.3 %some concernnot evaluable moderatenon important-
Neutropenia TRAE (grade 3-4) 0.08 [0.00, 14.71]< 193%2 studies (2/-)82.2 %some concernnot evaluable moderatenon important-
Pancreatitis TRAE (grade 3-4) 4.23 [0.47, 37.98]< 10%2 studies (2/-)10.0 %some concernnot evaluable moderatenon important-
Pneumonitis TRAE (grade 3-4) 3.70 [0.76, 17.95]< 10%2 studies (2/-)5.2 %some concernnot evaluable moderatenon important-
Pruritus TRAE (grade 3-4) 3.22 [0.30, 34.84]< 10%2 studies (2/-)17.0 %some concernnot evaluable moderatenon important-
Rash TRAE (grade 3-4) 2.23 [0.35, 14.10]< 10%2 studies (2/-)19.8 %some concernnot evaluable moderatenon important-
Sarcoidosis TRAE (grade 3-4) 1.05 [0.07, 16.88]< 10%2 studies (2/-)48.5 %some concernnot evaluable moderatenon important-
Severe skin reaction TRAE (grade 3-4) 2.46 [0.72, 8.32]< 10%2 studies (2/-)7.5 %some concernnot evaluable moderatenon important-
Thrombocytopenia TRAE (grade 3-4) 0.14 [0.00, 5.55]< 192%2 studies (2/-)84.9 %some concernnot evaluable moderatenon important-
Thyroiditis TRAE (grade 3-4) 1.58 [0.12, 20.66]< 10%2 studies (2/-)36.4 %some concernnot evaluable moderatenon important-
Vomiting TRAE (grade 3-4) 0.49 [0.07, 3.55]< 168%2 studies (2/-)76.1 %some concernnot evaluable moderatenon important-

AE (grade 3-4) endpoints 00

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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