TABLE 7.
Summary of nemonoxacin 500 mg safety in Phase II–IV studies stratified in patients with abnormal liver and kidney functions a .
| AEs incidences | Phase II/III b | Phase IV (China mainland) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A (n = 28) | B (n = 23) | A + B (n = 17) | NEMO-500 mg (n = 519) | RD c [95%CI] | A (n = 39) | B (n = 72) | A + B (n = 15) | NEMO-500 mg (n = 461) | RD c [95%CI] | |
| AEs | 12 (42.9) | 13 (56.5) | 9 (52.9) | 193 (37.2) | 15.7 [−8.3; 39.8] | 20 (51.3) | 24 (33.3) | 5 (33.3) | 200 (43.4) | 10.1 [−14.2; 34.3] |
| Drug-related AEs | 10 (35.7) | 9 (39.1) | 7 (41.2) | 119 (22.9) | 18.3 [−5.4; 41.9] | 13 (33.3) | 16 (22.2) | 3 (20.0) | 117 (25.4) | 5.4 [−15.3; 26.0] |
| Drug-related AEs led to study drug discontinuation | 3 (10.7) | 3 (13.0) | 3 (17.6) | 2 (0.4) | 17.2 [−0.9; 35.4] | 3 (7.7) | 1 (1.4) | 1 (6.7) | 13 (2.8) | 3.8 [−16.6; 8.9] |
| SAEs | 1 (3.6) | 1 (4.3) | 1 (5.9) | 12 (2.3) | 3.6 [−7.7; 14.8] | 1 (2.6) | 0 | 0 | 10 (2.2) | — |
| Drug-related SAEs | 0 | 0 | 0 | 1 (0.2) | — | 1 (2.6) | 0 | 0 | 2 (0.4) | — |
| Deaths | 0 | 0 | 0 | 1 (0.2) | — | 0 | 0 | 0 | 0 | — |
| Study drug-related AEs leading to deaths | 0 | 0 | 0 | 0 | — | 0 | 0 | 0 | 0 | — |
a
Abnormal liver and kidney function included: A with liver and/or kidney function abnormal baseline values that were clinically; B with ongoing liver and/or renal abnormalities; A + B means both A and B.
b
Based on Phase III, clinical and Phase II, clinical statistics numbered NCT01537250.
c
A + B VS. NEMO-500, mg.