Table 2. Summary of adverse events.
Symptoms | IVIG | Placebo | IVIG vs. Placebo | IVIG vs. Placebo | ||||
---|---|---|---|---|---|---|---|---|
JE (n = 7) | Non-JE (n = 4) | Total(n = 11) | JE (n = 6) | Non-JE (n = 5) | Total(n = 11) | P- value | OR(95% CI) | |
Fever | 2 (.29) | 2 (0.5) | 4 (.36) | 1 (.17) | 1 (0.2) | 2 (.18) | 0.64 | 2.6 (0.3–29) |
Dyspnoea | 1(.14) | 2 (0.5) | 3 (.27) | 1 (.17) | 1 (0.2) | 2 (.18) | 1 | 1.7 (0.2–20.1) |
Vomiting | 0 (0) | 0 (0) | 0 (0) | 1 (.17) | 0 (0) | 1 (0.9) | 1 | 0 (0–18.7) |
Irritable | 1(.14) | 1 (.25) | 2 (.18) | 2 (.33) | 0 (0) | 2 (.18) | 1 | 1 (0.07–13.5) |
Non-urticarial skin rash | 0 (0) | 0 (0) | 0 (0) | 1 (.17) | 0 (0) | 1 (0.9) | 1 | 0 (0–18.7) |
Hypotension* | 1(.14) | 0 (0) | 1 (0.9) | 1 (.17) | 0 (0) | 1 (0.9) | 1 | 1 (0–43.7) |
Melena* | 1(.14) | 0 (0) | 1 (0.9) | 0 (0) | 1 (0.2) | 1 (0.9) | 1 | 1 (0–43.7) |
Death* | 0 (0) | 1(.14) | 1 (0.9) | 0 (0) | 0 (0) | 0 (0) | 1 | NA |
Data are number of patients (proportion).
* Serious adverse events. NA: not applicable