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Treatment emergent adverse events and the types of adverse events that differed significantly between treatment groups
| Placebo (n = 86) | 800 mg IV-Ibuprofen (n = 99) | Safety population (n = 185) | P value | ||||
|---|---|---|---|---|---|---|---|
| Number of patients experiencing at least one adverse event | 74 (86%) | 90 (91%) | 164 (89%) | 0.356 | |||
| Adverse events that differed significantly between treatment groups | |||||||
| Type of adverse event | n | % | n | % | N | % | |
| Vomiting | 12 | (14%) | 27 | (27%) | 39 | (21%) | 0.031 |
| Dyspepsia | 4 | (5%) | 0 | 0 | 4 | (2%) | 0.045 |
