Table 2.
Adverse event reporting.
| Grade | Frequency | Dose | Description | Relation | Expectation |
|---|---|---|---|---|---|
| Mild | 7 | 3 g | Heartburn | Possibly related | Unexpected |
| 3 g | Heart palpitations | Unlikely related | Unexpected | ||
| 6 g | Constipation | Unlikely related | Unexpected | ||
| 6 g | Chest pain | Possibly related | Unexpected | ||
| 6 g | Fever with concomitant R dermatitis (2) | Unlikely related | Unexpected | ||
| 9 g | Cold or Flu-like symptoms | Unlikely related | Unexpected | ||
|
| |||||
| Moderate | 1 | 6 g | Fatigue; secondary to UT infection | Unlikely related | Unexpected |
|
| |||||
| Severe | 1 | 6 g | Anxiety event | Possibly related | Unexpected |
|
| |||||
| Total | 9 | ||||