Table 4.
Infant QTc values in the safety population.
| Outcome | Ondansetron (N=48) | Placebo (N=44) | Difference (95% CI) | P Value |
|---|---|---|---|---|
| Mean number of ECG (range) | 3.3 (0 to 5) | 3.6 (0 to 5) | −0.3 (−1.1 to 0.5) | 0.46 b |
| Baseline QTc (in ms) | 423.6 | 418.9 | 4.7 (−9.7 to 19.1) | 0.52 b |
| Mean QTc after receipt of first infant dose a (in ms) | 435.3 | 429.1 | 6.2 (−9.9 to 22.3) | 0.45 b |
| Mean QTc change from baseline (initial QTc – mean of all post dose values) | −15.7 | −17.7 | 2.0 (−15.8 to 19.8) | 0.83 b |
a
This refers to mean of all QTc values measured for post doses
b
Two-sample t-test.