TABLE 3. Central nervous system adverse events during the dosing period in 32 patients receiving cyclosporine and 8 receiving placebo*.
Event | Cyclosporine Groups | Placebo Group | p Value |
---|---|---|---|
cerebral edema | 0 | 1 | 0.05 |
intracranial hypertension | 21 | 6 | 0.45 |
decerebrate posturing | 3 | 1 | 0.79 |
decreased CPP | 28 | 7 | 0.89 |
seizures | 2 | 0 | 0.47 |
Values represent numbers of patients unless otherwise indicated. Definitions for all adverse events were agreed upon prior to initiation of the protocol in any patient. The events recorded in this table met the definition at any time point following the first dose of the study drug. Cerebral edema was defined as a new onset of fluid accumulation in the brain tissue; intracranial hypertension was defined as a clinically significant elevation of ICP that disrupts autoregulation (usually > 20 mm Hg; > 40 mm Hg sustained was defined as severe elevation); decerebrate posturing was defined as decerebrate rigidity with the extremities stiff and extended; decreased CPP was defined as any recorded value < 60 mm Hg; seizures were defined as sudden, involuntary contractions accompanied by electroencephalography changes.