Janssen AD26 vaccine (JNJ-78436735) - versus potential COVID-19 treatments - for COVID-19 prophylaxis (excluding children) pdf   xlsx method abbreviations

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 0.19 [0.04, 0.81]< 10%1 study (1/-)98.7 %NAnot evaluable crucial-
hospitalization 0.18 [0.03, 1.17]< 10%1 study (1/-)96.3 %NAnot evaluable important-
symptomatic Covid-19 0.33 [0.27, 0.41]< 10%1 study (1/-)100.0 %NAnot evaluable important-
severe COVID-19 occurrence 0.23 [0.11, 0.48]< 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

ATE (Myocardial infarction or ischemic stroke) 0.50 [0.12, 2.00]< 10%1 study (1/-)83.6 %NAnot evaluable non important-
deep vein thrombosis 3.00 [0.61, 14.86]< 10%1 study (1/-)9.0 %NAnot evaluable non important-
Guillain-Barré syndrome 1.00 [0.06, 15.98]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
ischemic stroke 0.67 [0.11, 3.99]< 10%1 study (1/-)67.1 %NAnot evaluable non important-
Myocardial infarction 1.00 [0.02, 50.39]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
pericarditis 2.00 [0.07, 59.60]< 10%1 study (1/-)34.7 %NAnot evaluable non important-
pulmonary embolism 4.00 [0.45, 35.79]< 10%1 study (1/-)10.9 %NAnot evaluable non important-
venous thromboembolism 2.75 [0.88, 8.64]< 10%1 study (1/-)4.2 %NAnot evaluable non important-

AE of interest endpoints 00

cerebral venous sinus thrombosis (CVST) 2.00 [0.07, 59.60]< 10%1 study (1/-)34.7 %NAnot evaluable important-
appendicitis 1.20 [0.37, 3.93]< 10%1 study (1/-)38.2 %NAnot evaluable non important-
Bell's palsy 1.50 [0.25, 8.98]< 10%1 study (1/-)32.9 %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.