TABLE 1.
Subject demographics and disposition
| Study | No. enrolled
|
Enrollment mean (range)
|
Withdrawals
|
|||||
|---|---|---|---|---|---|---|---|---|
| Sex
|
Smokers | Age (yr) | Wt (kg) | Completed | AEa | Other | ||
| Male | Female | |||||||
| Theophylline | 8 | 4 | 1 | 41 (21–68) | 78 (56–97) | 10 | 1b | 1c |
| Caffeine | 8 | 4 | 2 | 43 (24–66) | 82 (62–104) | 11 | 0 | 1c |
| Warfarin | 12 | 0 | 0 | 25 (21–31) | 77 (62–90) | 10 | 0 | 2d |
| Clinafloxacin on phenytoin | 2 | 13 | 3 | 38 (25–59) | 90 (64–124) | 11 | 4e | 0 |
| Phenytoin on clinafloxacin | 6 | 10 | 3 | 39 (28–52) | 83 (53–113) | 14 | 2f | 0 |
a
AE, adverse event.
b
Diarrhea considered severe in intensity and probably related to clinafloxacin administration.
c
Withdrew for personal reasons.
d
Failure to maintain INR of <2.5 before receiving clinafloxacin.
e
Two subjects for elevated liver function values, one subject for pruritis and rash, and one subject for nervousness—all considered by the clinician to be probably related to phenytoin.
f
For rash considered by the clinician to be related to phenytoin.