Vaccine Group Events
9
Rate: 1.20 / 1,000
Placebo Group Events
9
Rate: 1.20 / 1,000
Observed Risk Ratio
1.00
95% CI: [0.39, 2.56]
P-Value (Fisher Exact)
1.0000
Signal: None (Parity)
Vaccine Arm
Placebo Arm
Required sample sizes to achieve 80% statistical power (α=0.05) for rare adverse reactions.
WHO Adverse Event Causality Assessment Tree
Active Case File: Guillain-Barré Syndrome |
Onset: 12 Days post-vaccination |
Background Rate: 1.5 / 100k/yr
Clinical Details: Recent Campylobacter jejuni infection confirmed by lab test.
Clinical Details: Recent Campylobacter jejuni infection confirmed by lab test.
Step 1: Is there strong evidence for an alternative etiology?
Does the patient have a confirmed underlying condition or lab-verified infection explaining the event?
Step 2: Is the temporal relationship biologically plausible?
Did the event occur within the established window of biological plausibility post-vaccination?
Step 3: Is there biological mechanism or trial evidence supporting causality?
Is there verified clinical/lab evidence or double-blind trial parity deviation?
Final Classification: Unlikely / Inconsistent with causal association (Alternative Etiology Present)