TABLE 5.
Summary of AEs for Cefaclor granule and Cefaclor suspension in the fasting trial.
| AE category | Cefaclor granule a | Cefaclor suspension a | ||
|---|---|---|---|---|
| N | n | N | n | |
| Total adverse events | 5 | 5 | 6 | 8 |
| AEs related to the study drugs | 5 | 5 | 6 | 8 |
| Anemia | 1 | 1 | 0 | 0 |
| Vomited | 0 | 0 | 1 | 1 |
| Sweating | 0 | 0 | 1 | 1 |
| Slow pulse | 0 | 0 | 1 | 1 |
| Dizziness | 0 | 0 | 1 | 1 |
| Infection urinary tract | 2 | 2 | 0 | 0 |
| Urinary occult blood positive | 2 | 2 | 4 | 4 |
| AEs of grade 1 | 5 | 5 | 6) | 6 |
| AEs of grade 2 | 0 | 0 | 1 | 2 |
| AEs of grade 3 and above | 0 | 0 | 0 | 0 |
| AEs leading to discontinuation of study drug | 0 | 0 | 2 | 4 |
a
Subject with random number K014 discontinued the trial due to AEs. Blood samples were collected from subjects prior to oral medication, so subject participated in SS but not PKPS and BES. Subject with random number K024 discontinued the trial due to AEs. Blood samples were collected within 2 hours after oral administration Cefaclor suspension, therefore, the subject enrolled in SS and PKPS but not BES. The number of cefaclor was 22, the number of Cefaclor suspension was 24.
N, number of the subjects with adverse events; n, the number of adverse events; AEs, adverse events.