TABLE 4.
Summary of adverse events (safety population)
| Parameter | Value |
||
|---|---|---|---|
| Peramivir |
Placebo (n = 100) | ||
| 300 mg (n = 99) | 600 mg (n = 99) | ||
| No. of events | 252 | 252 | 257 |
| No. (%) of patients with ≥1 event | 87 (87.9) | 90 (90.9) | 91 (91.0) |
| 95% CI (%) | 79.8, 93.6 | 83.4, 95.8 | 83.6, 95.8 |
| Pa | 0.4986 | 1.0000 | |
| Adverse events (≥6% in either group) [n (%) of patients] | |||
| Monocyte % increased | 20 (20.2) | 18 (18.2) | 31 (31.0) |
| Blood glucose increased | 18 (18.2) | 17 (17.2) | 18 (18.0) |
| Diarrhea | 14 (14.1) | 15 (15.2) | 17 (17.0) |
| Lymphocyte % increased | 14 (14.1) | 14 (14.1) | 5 (5.0) |
| Proteinuria present | 9 (9.1) | 11 (11.1) | 18 (18.0) |
| White blood cells urine positive | 8 (8.1) | 9 (9.1) | 8 (8.0) |
| β2 Microglobulin in urine increased | 14 (14.1) | 8 (8.1) | 11 (11.0) |
| White blood cell count decreased | 9 (9.1) | 7 (7.1) | 4 (4.0) |
| Blood bilirubin increased | 7 (7.1) | 8 (8.1) | 7 (7.0) |
| Alanine aminotransferase increased | 4 (4.0) | 7 (7.1) | 8 (8.0) |
| Aspartate aminotransferase increased | 1 (1.0) | 7 (7.1) | 6 (6.0) |
| α1 Microglobulin increased | 6 (6.1) | 6 (6.1) | 6 (6.0) |
| Nausea | 3 (3.0) | 6 (6.1) | 1 (1.0) |
| Blood lactate dehydrogenase increased | 2 (2.0) | 6 (6.1) | 4 (4.0) |
| β-N-Acetyl-d-glucosaminidase | 9 (9.1) | 5 (5.1) | 5 (5.0) |
| Urine albumine present | 5 (5.1) | 5 (5.1) | 6 (6.0) |
| Protein total decreased | 3 (3.0) | 4 (4.0) | 6 (6.0) |
| Lymphocyte morphology abnormal | 11 (11.1) | 4 (4.0) | 6 (6.0) |
| Nasopharyngitis | 0 (0.0) | 4 (4.0) | 6 (6.0) |
| Blood phosphate increased | 6 (6.0) | 3 (3.0) | 4 (4.0) |
a
The P value was calculated by intergroup comparison between peramivir and placebo groups using Fisher's exact test.