Research Article
Safety Evaluation in Healthy Colombian Volunteers of P2Et Extract Obtained from Caesalpinia spinosa: Design 3+3 Phase I Clinical Trial
Table 5
Incidence of adverse events in level 1 dosing.
| | | P2Et 600 mg/d | | n | Events (%) |
| | Epigastric pain | 3 | 7 (16.7) | | Myalgia | 2 | 3 (7.1) | | Retching | 3 | 3 (7.1) | | Adynamia | 2 | 2 (4.8) | | Asthenia | 2 | 2 (4.8) | | Constipation | 2 | 2 (4.8) | | Odynophagia | 2 | 2 (4.8) | | Reflux | 2 | 2 (4.8) | | Acute nasopharyngitis | 2 | 2 (4.8) | | Increase AST | 1 | 1 (2.4) | | Increase bowel habit frequency | 1 | 1 (2.4) | | Increase abdominal bowel sounds | 1 | 1 (2.4) | | Cervical pain | 1 | 1 (2.4) | | Nail cyanosis at the level of the upper limbs not associated with paresthesias | 1 | 1 (2.4) | | Soft stool | 1 | 1 (2.4) | | Abdominal distention | 1 | 1 (2.4) | | Flatulence | 1 | 1 (2.4) | | Hypogammaglobulinemia | 1 | 1 (2.4) | | Hyporexia | 1 | 1 (2.4) | | Leukopenia | 1 | 1 (2.4) | | Neutropenia | 1 | 1 (2.4) | | Oliguria | 1 | 1 (2.4) | | Polydipsia | 1 | 1 (2.4) | | Feeling of fullness | 1 | 1 (2.4) | | Sensation of emptiness in epigastrium | 1 | 1 (2.4) | | Cough | 1 | 1 (2.4) |
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AST, aspartate aminotransferase.
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