Table 2.
Summary of Adverse Events
| Adverse event | n (%) subjects | n (%) incidents |
|---|---|---|
| Gastrointestinal complaints | 12 (33%) | 18 (35%) |
| Nausea | 7 | 9 |
| Vomiting | 2 | 2 |
| Weight gain | 1 | 1 |
| Diarrhea | 2 | 2 |
| Bad taste | 1 | 1 |
| Acid reflux | 3 | 3 |
| Respiratory symptoms | 2 (6%) | 3 (6%) |
| Shortness of breath | 2 | 3 |
| General/ear, nose, throat | 14 (39%) | 9 (17%) |
| Cold symptoms/viral illness | 7 | 7 |
| Fever | 1 | 2 |
| Cough | 2 | 2 |
| Fatigue | 1 | 1 |
| Difficulty swallowing | 1 | 1 |
| Hearing changes | 1 | 1 |
| Headaches | 6 | 8 |
| Genitourinary complaints | 2 (6%) | 2 (4%) |
| Urinary retention | 1 | 1 |
| Menstrual irregularity | 1 | 1 |
| Psychiatric complaints | 4 (11%) | 9 (17%) |
| Irritability | 2 | 3 |
| Mood swings | 2 | 3 |
| Worsening depression | 1 | 1 |
| Panic attack | 1 | 1 |
| Suicide attempt | 1 | 1 |
| Skin and subcutaneous tissue | 6 (17%) | 8 (15%) |
| Canker sore | 2 | 2 |
| Redness | 1 | 1 |
| Burning sensation | 1 | 1 |
| Numbness | 1 | 1 |
| Tingling | 1 | 1 |
| Swelling | 1 | 2 |
| Other events | 2 (6%) | 3 (6%) |
| Ankle injury | 1 | 1 |
| Sternal pain | 1 | 1 |
| Sexual assault | 1 | 1 |