Table 4.
Analysis of the pooled STRATUS EU, US, and META adverse events (AEs) that occurred during the 10-week medication phase and for 6 weeks after medication ended for the studies. The listed AEs impacted at least 2% of the total sample.
| Adverse Event (AE) | Placebo (N=789) | 5 mga (N=518) | 20 mg (N=790) |
|---|---|---|---|
| Any AEs reported (%) | 60.96% (481) | 61.00 (316) | 69.62 (550)*** |
| Upper Respiratory Disturbance | 21.67% (171) | 27.03% (140)* | 22.91% (181) |
| Headache | 15.72% (124) | 19.11% (99) | 11.39% (90)* |
| Sleep Disturbance | 12.29% (97) | 13.51% (70) | 15.19% (120) |
| Nausea | 6.84% (54) | 7.92% (41) | 18.48% (146)*** |
| Dyspepsia | 10.14% (80) | 9.85% (51) | 9.75% (77) |
| Diarrhea | 6.46% (51) | 7.34% (38) | 11.39% (90)*** |
| Depressive Symptoms | 7.35% (58) | 6.56% (34) | 9.24% (73) |
| Anxiety Symptoms | 5.70% (45) | 7.34% (38) | 9.75% (77)** |
| Dizziness | 6.59% (52) | 6.37% (33) | 9.11% (72) |
| Fatigue | 5.45% (43) | 4.83% (25) | 6.08% (48) |
| Influenza | 4.69% (37) | 6.18% (32) | 5.19% (41) |
| Irritability | 5.45% (43) | 4.63% (24) | 5.06% (40) |
| Hyporexia | 2.15% (17) | 3.28% (17) | 6.20% (49)*** |
| Back Pain | 3.68% (29) | 3.67% (19) | 4.30% (34) |
| Vomiting | 2.03% (16) | 2.12% (11) | 5.32% (42)*** |
| Dry Mouth | 2.28% (18) | 2.51% (13) | 3.42% (27) |
| Attentional Disturbance | 2.41% (19) | 1.54% (8) | 3.42% (27) |
| Constipation | 3.68% (29) | 1.93% (10) | 1.52% (12)** |
| Cough | 3.42% (27) | 1.54% (8)* | 1.77% (14)* |
| Arthralgia | 2.79% (22) | 2.12% (11) | 1.39% (11) |
Note:
*
p < .05,
**
p < .01,
***
p < .001.
a
The AEs report for the 5 mg sample are for the EU & US samples only.
EOT = end of treatment; AEs = adverse events.