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Janssen AD26 vaccine (JNJ-78436735) - versus control - 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 0.32 [0.19, 0.54]< 128%2 studies (1/1)100.0 %seriousnot evaluable lownon 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-
intracranial hemorrhage 1.59 [0.60, 4.21]< 10%1 study (-/1)17.6 %NAnot evaluable non important-
ischemic stroke 1.05 [0.65, 1.71]< 10%2 studies (1/1)42.0 %NAnot evaluable non important-
Myocardial infarction 1.70 [1.14, 2.55]< 10%3 studies (2/1)0.5 %NAnot evaluable non important-
myocarditis 5.11 [0.70, 37.23]< 10%1 study (-/1)5.5 %NAnot evaluable non important-
pericarditis 2.00 [0.07, 59.60]< 10%1 study (1/-)34.7 %NAnot evaluable non important-
pulmonary embolism 0.80 [0.16, 3.93]< 141%3 studies (2/1)61.0 %lownot evaluable highnon 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.



 

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