Table 7.
Details of serious adverse events in women with uncomplicated urinary tract infection randomised to ibuprofen or fosfomycin
Diagnosis | Age (years) | Beginning (days from randomisation) | Hospital admission | Trial drug |
---|---|---|---|---|
Bleeding gastric ulcer | 58 | 22 | Yes | Ibuprofen |
Cardiac palpitations | 37 | 1 | Yes | Ibuprofen |
Missed miscarriage* | 18 | 63 | Yes | Ibuprofen |
Acute appendicitis | 21 | 18 | Yes | Ibuprofen |
*One woman assigned to ibuprofen group proved to be pregnant despite negative pregnancy test result at inclusion. Both GP and gynaecologist thought miscarriage was not associated treatment drug.