pdf   xlsx method abbreviations

metastatic/advanced OC (mOC) - 2nd line (L2), avelumab 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) 1.14 [0.88, 1.47]< 10%1 study (1/-)15.6 %NAnot evaluable crucial-
progression or deaths (PFS) 1.68 [1.20, 2.36]< 10%1 study (1/-)0.1 %NAnot evaluable important-
DCR 2.02 [1.33, 3.07]> 10%1 study (1/-)100.0 %NAnot evaluable non important-
objective responses (ORR) 0.89 [0.27, 2.92]> 10%1 study (1/-)42.4 %NAnot evaluable non important-

safety endpoints 00

TRAE (any grade) 0.45 [0.26, 0.76]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
TRAE (grade 3-4) 0.41 [0.24, 0.68]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.95 [0.06, 15.24]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.87 [0.38, 1.95]< 10%1 study (1/-)63.7 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Abdominal pain TRAE (grade 3-4) 0.47 [0.02, 14.15]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Acute kidney injury TRAE (grade 3-4) 1.90 [0.06, 56.93]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Adrenal insufficiency TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.30 [0.08, 1.14]< 10%1 study (1/-)96.1 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.47 [0.02, 14.15]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Blood creatinine increased TRAE (grade 3-4) 1.90 [0.06, 56.93]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 9.70 [0.53, 178.83]< 10%1 study (1/-)6.5 %NAnot evaluable non important-
Dry skin TRAE (grade 3-4) 0.47 [0.02, 14.15]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 1.90 [0.06, 56.93]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.16 [0.01, 3.13]< 10%1 study (1/-)88.5 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.16 [0.01, 3.13]< 10%1 study (1/-)88.5 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 1.90 [0.06, 56.93]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Hypersensitivity TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Hypertension TRAE (grade 3-4) 3.82 [0.17, 85.21]< 10%1 study (1/-)20.2 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.90 [0.06, 56.93]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 3.82 [0.17, 85.21]< 10%1 study (1/-)20.2 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 1.90 [0.06, 56.93]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 0.47 [0.02, 14.15]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.16 [0.01, 3.13]< 10%1 study (1/-)88.5 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 0.47 [0.02, 14.15]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Mucosal inflammation TRAE (grade 3-4) 0.31 [0.03, 3.03]< 10%1 study (1/-)84.1 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.47 [0.02, 14.15]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.05 [0.00, 0.87]< 10%1 study (1/-)97.9 %NAnot evaluable non important-
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) 0.05 [0.00, 0.87]< 10%1 study (1/-)97.9 %NAnot evaluable non important-
Pancytopenia TRAE (grade 3-4) 0.23 [0.01, 5.24]< 10%1 study (1/-)81.7 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Peripheral oedema TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Pneumonia TRAE (grade 3-4) 1.90 [0.06, 56.93]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 0.95 [0.06, 15.24]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Pruritic rash TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.16 [0.01, 3.13]< 10%1 study (1/-)88.5 %NAnot evaluable non important-
Sepsis TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Skin exfoliation TRAE (grade 3-4) 0.95 [0.02, 47.96]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 0.09 [0.01, 1.70]< 10%1 study (1/-)94.4 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.47 [0.02, 14.15]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.31 [0.03, 3.03]< 10%1 study (1/-)84.1 %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.