Table 3.
Incidence of adverse events by body system and group
| Body System and Preferred Term* | TPTD | Placebo | Total |
|---|---|---|---|
| N (%) | N (%) | N (%) | |
| Number of Patients | 18 | 17 | 35 |
| Number of Events | 35 | 18 | 53 |
| Number of Patients with Events | 12 (67) | 10 (59) | 22 (63) |
| Head | |||
| Dizziness/faintness | 1 (3) | 1 (2) | |
| Nose/Throat | |||
| Difficulty swallowing | 1 (6) | ||
| Flu/Upper Respiratory Problems | 1 (3) | 1(2) | |
| Sinus Condition | 1 (3) | 2 (11) | 3 (6) |
| Chest | |||
| Shortness of breath | 1 (6) | 1 (2) | |
| Gastrointestinal | |||
| Nausea | 1 (3) | 2 (11) | 3 (6) |
| Vomiting | 1 (3) | 1 (2) | |
| Diarrhea | 1 (3) | 1 (6) | 2 (4) |
| Appetite decrease | 1 (3) | 1 (2) | |
| Genitourinary | |||
| Painful urination | 1 (3) | 1 (2) | |
| Difficulty urinating | 1 (3) | 1 (2) | |
| Increased frequency of urination | 2 (6) | 2 (4) | |
| Musculoskeletal | |||
| Muscle/bone/joint pain/condition | 7 (20) | 2(11) | 9 (17) |
| Edema | 2 (6) | 1 (6) | 3 (6) |
| Psychological/Behavioral | |||
| Tiredness/fatigue | 2 (6) | 2 (4) | |
| Other | |||
| Accidental injury | 5 (14) | 3 (17) | 8 (15) |
| Medical or surgical procedure | 3 (17) | 3 (6) | |
| Not Otherwise Listed (or Unknown) | 8 (23) | 3 (17) | 11 (21) |