Table 3.
Percentage of participants reporting extra-intestinal symptoms at Baseline and End-of-Study
| Symptoms at Baseline | Symptoms at End of Study | ||||||
|---|---|---|---|---|---|---|---|
| DBM (N=30) | DBP (N=71) | TAU (N=72) | DBM (N=30) | DBP (N=71) | TAU (N=72) | ||
| SLEEP | Bad dreams (%) | 40.0 | 40.8 | 45.8 | 26.7* | 25.4 | 29.2 |
| Excessive sleepiness (%) | 43.3 | 38.0 | 47.2 | 30.0* | 25.4 | 26.4 | |
| Insomnia (%) | 36.7 | 33.8 | 40.3 | 20.0 | 26.8 | 31.9 | |
| Fatigue (%) | 63.3 | 52.1 | 70.8 | 30.0 | 52.1 | 61.1 | |
| NEURO | Inability to concentrate (%) | 43.3 | 43.7 | 38.9 | 23.3 | 35.2 | 26.4 |
| Irritability (%) | 33.3 | 43.7 | 44.4 | 10.0 | 21.1 | 36.1 | |
| Dry mouth (%) | 33.3 | 23.9 | 25.0 | 20.0* | 15.5 | 19.4 | |
| Headache (%) | 36.7 | 36.6 | 47.2 | 30.0* | 23.9 | 38.9 | |
| Weakness (%) | 13.3 | 14.1 | 23.6 | 13.3* | 5.6 | 11.1 | |
| Dizziness (%) | 26.7 | 22.5 | 25.0 | 26.7* | 11.3 | 18.1 | |
| MSK | Joint pain (%) | 33.3 | 35.2 | 33.3 | 13.3 | 21.1 | 27.8 |
| Muscle pain (%) | 30.0 | 32.4 | 27.8 | 6.7 | 15.5 | 20.8 | |
| RESP | Nasal congestion (%) | 46.7 | 42.3 | 38.9 | 26.7 | 38.0 | 37.5 |
| DERM | Skin rash (%) | 10.0 | 18.3 | 16.7 | 13.3* | 9.9 | 11.1 |
| Bruising (%) | 13.3 | 15.5 | 9.7 | 3.3 | 11.3 | 8.3 | |
*
Denotes symptoms that would be attributed to the study drug using the following, common definition of side effects: present in at least 2% of the drug group and at a higher incidence than placebo group at study end point.