Table 2. Summary of primary and secondary (safety) outcomes plus comparative statistics (intention-to-treat population).
Outcome | EchiTAb Plus-ICP | EchiTAb G | Relative Risk1 | P-value2 |
(n = 194) | (n = 206) | (one-sided 95% CI) | ||
PRIMARY OUTCOME | ||||
Permanent restoration of blood coagulability (20WBCT) 6 hr after 1st dose of antivenom | 161 (83.0%) | 156 (75.7%) | 1.10 (Lower limit 1.01) | 0.05 |
SECONDARY (SAFETY) OUTCOMES | ||||
Early anaphylactic-type reactions | ||||
Patients experiencing ≥1 reaction | 50 (25.8%) | 39 (18.9%) | 1.36 (Upper limit 1.86) | 0.06 |
Early pyrogenic reactions | 0 | 0 | inestimable | N/A |
Late serum sickness type reactions | 5/49 (10.2%) | 3/58 (5.2%) | 1.97 (Upper limit 6.28) | 0.27 |
Lower limit appropriate when comparing antivenom effectiveness (positive events); upper limit appropriate when comparing safety (negative events).
One-sided P-values calculated using Fisher's Exact test.