Table 2. Bleeding Event Rate by Noninferiority mITT Analysisa.
| Bleeding Event | No. (%) of Patients | % Difference (1-Sided 97.5% CI)b | Noninferiority P Valuec | |
|---|---|---|---|---|
| Ibuprofen (n = 345) | Acetaminophen (n = 343) | |||
| Most Severe Bleeding Eventd | ||||
| Type 1 | 16 (4.6) | 14 (4.1) | NA | NA |
| Type 2 | 12 (3.5) | 9 (2.6) | NA | NA |
| Type 3e | 10 (2.9) | 4 (1.2) | 1.7 (3.8) | .12 |
| Total children with bleeding | 38 (11.0) | 27 (7.9) | NA | NA |
| Most Severe Secondary Bleeding Event (mITT Analysis)d | ||||
| Type 1 | 16 (4.6) | 12 (3.5) | NA | NA |
| Type 2 | 10 (2.9) | 5 (1.5) | NA | NA |
| Type 3e | 8 (2.3) | 4 (1.2) | 1.17 (3.1) | .03 |
| Total children with bleeding | 34 (10.0) | 21 (6.2) | NA | NA |
| Most Severe Bleeding Event Rate (per Protocol Analysis)d,f | ||||
| Type 1 | 5 (3.4) | 1 (0.8) | NA | NA |
| Type 2 | 4 (2.8) | 3 (2.5) | NA | NA |
| Type 3e | 2 (1.4) | 2 (1.6) | 0.26 (2.69) | .02 |
| Total children with bleeding | 11 (7.6) | 6 (4.9) | NA | NA |
Abbreviations: mITT, modified intention-to-treat; NA, not applicable.
a
Noninferiority mITT analysis was performed only for type 3 bleeding.
b
Noninferiority is not achieved if the 1-sided 97.5% CI surpasses the noninferiority margin of 3%.
c
P values correspond to 1-sided CIs with noninferiority margin of 3.0%. P values <.025 are considered statistically significant.
d
The most severe type of bleeding event was included for children with multiple bleeding events.
e
Primary outcome measure.
f
Populations for these outcomes were 145 for ibuprofen and 122 for acetaminophen.