TABLE 4.
Summary of nemonoxacin 500 mg in postmarketing surveillance.
| Characteristics | Phase IV (China mainland) (n = 461) | PK study 1 | PK study 2 | PMOS1 (n = 444) | PMOS2 (n = 337) a | PMOS3 (n = 583) | PMOS4 (n = 488) | Database (n≈257, 420) b | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Hepatic impairment group (n = 10) | Healthy group (n = 10) | Renal impairment group (n = 10) | Healthy group (n = 10) | |||||||
| Sex (%) | ||||||||||
| Males | 227 (49.2) | 5 (50.0) | 5 (50.0) | 7 (70.0) | 7 (70.0) | 249 (56.1) | 132 (40.9) | 237 (40.7) | 265 (54.3) | 67 (57.3) |
| Females | 234 (50.8) | 5 (50.0) | 5 (50.0) | 3 (30.0) | 3 (30.0) | 195 (43.9) | 191 (59.1) | 346 (59.3) | 223 (45.7) | 50 (42.7) |
| Age (years) | ||||||||||
| Mean (SD) | 43.5 ± 15.9 | 54.10 ± 9.31 | 54.30 ± 11.25 | 45.38 ± 11.64 | 45.85 ± 10.95 | 53.59 ± 14.5 | 52 (34, 61) c | 48.1 ± 16.0 | 53.3 ± 14.5 | 53.4 ± 17.4 |
| Elderly (≥ 60 years) | 95 (20.6) | 4 (40.0) | 3 (30.0) | 1 (10.0) | 1 (10.0) | 158 (35.6) | -- | ≥65: 101 (17.3) | ≥≥ 65: 125 (25.6) | ≥70: 19 (16.2) |
| Treatment duration (day) | ||||||||||
| Mean (SD) | 8.5 ± 2.1 | 1 | 1 | 1 | 1 | 6.82 ± 2.4 | 8.24 ± 3.7 | 5.79 ± 2.1 | 7.6 ± 4.3 | 5.2 ± 3.8 |
| AEs | 200 (43.4) | 6 (60.0) | 3 (30.0) | 8 (80.0) | 2 (20.0) | 6 (1.4) | 6 (1.9) | 11 (1.9) | 2 (0.4) | 117 (0.045) |
| Drug-related AEs | 117 (25.4) | 5 (50.0) | 3 (30.0) | 3 (30.0) | 0 | 5 (1.1) | 6 (1.9) | 11 (1.9) | 1 (0.2) | 117 (0.045) |
| Drug-related AEs led to study drug discontinuation | 13 (2.8) | 0 | 0 | 0 | 0 | 2 (0.4) | 0 | 0 | 1 (0.2) | 77 (0.03) |
| SAEs | 10 (2.2) | 0 | 0 | 0 | 0 | 0 | 1 (0.3) | 0 | 0 | 6 (0.002) |
| SAEs related to the study drug | 2 (0.4) | 0 | 0 | 0 | 0 | 0 | 1 (0.3) | 0 | 0 | 6 (0.002) |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
a
14 patients were lost during the follow-up period;9.
b
Include a total of 257,420 patients with 2,630 feedbacks and 217 ICSRs, in 117 users.
c
Expressed as age median (P25, P75).
-- not reported.