Table 3.
Summary of AE patterns in each part of the study.
| Pyragrel | AE Type | Ozagrel/placebo | AE Type | |
|---|---|---|---|---|
| Part I | ||||
| 30 mg | 2 | DB elevation, palpitation | 1 | DB elevation |
| 60 mg | 2 | Leucocytes increase, positive urine protein | 0 | 0 |
| 120 mg | 1 | DB elevation | 1 | DB elevation |
| 180 mg | 3 | DB elevation (2), ventosity | 1 | abdominal pain |
| 240 mg | 2 | APTT extension | 0 | 0 |
| 300 mg | 2 | Lower hemoglobin, total bile acid increase | 0 | 0 |
| Part II | 2 | DB/TB elevation | N/A | N/A |
| Part III | 12 | DB/TB elevation, alanine aminotransferase elevated, abdominal pain, headache, low blood potassium, urine frequency, fecal OBT+. | N/A | N/A |
| Part IV | 8 | Dizziness, TB/DB elevation, transient left tinnitus, double upper arm papules, fatigue | N/A | N/A |
| Part V | 1 | DB elevation | N/A | N/A |
| Total | 35 | 3 |
TB, total bilirubin; DB, direct bilirubin; OBT, fecal occult blood test, APTT, activated partial thromboplastin time. N/A, not applicable.