pdf   xlsx method abbreviations

urothelial cancer (UC) - bladder cancer (BC), 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) 0.69 [0.56, 0.86]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
deaths (OS) (extension) 0.76 [0.63, 0.92]< 10%1 study (1/-)99.8 %NAnot evaluable important-
PFS (extension) 0.54 [0.45, 0.64]< 10%1 study (1/-)100.0 %NAnot evaluable important-
progression or deaths (PFS) 0.62 [0.52, 0.74]< 10%1 study (1/-)100.0 %NAnot evaluable important-
DCR 1.85 [1.35, 2.54]> 10%1 study (1/-)100.0 %NAnot evaluable non important-
objective responses (ORR) 7.46 [2.53, 21.97]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 13.83 [6.28, 30.48]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
AE (grade 3-4) 3.85 [2.72, 5.44]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
AE leading to death (grade 5) 4.03 [0.18, 89.68]< 10%1 study (1/-)19.2 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 93.23 [5.71, 1522.42]< 10%1 study (1/-)0.1 %NAnot evaluable non important-
SAE (any grade) 1.55 [1.09, 2.21]< 10%1 study (1/-)0.8 %NAnot evaluable non important-
STRAE (any grade) 68.24 [4.16, 1120.28]< 10%1 study (1/-)0.2 %NAnot evaluable non important-
TRAE (any grade) 290.72 [105.09, 804.24]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE (grade 3-4) 133.97 [8.24, 2178.15]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 73.11 [4.46, 1198.64]< 10%1 study (1/-)0.1 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Arthralgia TRAE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Arthritis TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Chills TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 4.03 [0.18, 89.68]< 10%1 study (1/-)19.2 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Dry skin TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Guillain-Barré syndrome TRAE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 20.63 [1.20, 354.60]< 10%1 study (1/-)2.0 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 6.06 [0.30, 121.47]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Myositis TRAE (grade 3-4) 4.03 [0.18, 89.68]< 10%1 study (1/-)19.2 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Pancreatitis TRAE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Uveitis TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-
Vitiligo TRAE (grade 3-4) 1.00 [0.02, 50.69]< 10%1 study (1/-)49.9 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

hepatitis (Autoimmune) AE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 1.32 [0.57, 3.04]< 10%1 study (1/-)26.1 %NAnot evaluable non important-
Arthralgia AE (grade 3-4) 4.03 [0.18, 89.68]< 10%1 study (1/-)19.2 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.12 [0.01, 2.36]< 10%1 study (1/-)91.5 %NAnot evaluable non important-
Back pain AE (grade 3-4) 0.50 [0.15, 1.66]< 10%1 study (1/-)87.2 %NAnot evaluable non important-
Constipation AE (grade 3-4) 4.03 [0.18, 89.68]< 10%1 study (1/-)19.2 %NAnot evaluable non important-
Cough AE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.50 [0.05, 5.54]< 10%1 study (1/-)71.2 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 2.01 [0.18, 22.29]< 10%1 study (1/-)28.6 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 3.04 [0.61, 15.19]< 10%1 study (1/-)8.8 %NAnot evaluable non important-
Hypothyroidism AE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Infusion-related reaction AE (grade 3-4) 6.06 [0.30, 121.47]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.50 [0.05, 5.54]< 10%1 study (1/-)71.2 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Rash AE (grade 3-4) 2.01 [0.07, 60.08]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 2.02 [0.37, 11.09]< 10%1 study (1/-)21.1 %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.