Table 2.
Summary of Adverse Events Reported Across All Studies.
| Percentages (%) and Totals Showing Adverse Events Across Studies Percent of Study Sample Showing AE | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study: | 1 | 2 | 4 | 6 | 7 | 8 | 9 | 10 | Total Subjects Across Studies | ||
| Adverse Event | Sample Size: | 20 | 16 | 16 | 12 | 48 | 12 | 55 | 14 | 48 | |
| Decreased Appetite | (30) | (75) | (44) | (83) | (2) | (42) | (24) | – | (27) | 66 (29.1, 27.4%) | |
| Nausea | – | (100) | (13) | – | – | – | (13) | (36) | (29) | 44 (29.5, 18.3%) | |
| Irritability | – | (88) | (57) | (75) | (8) | (17) | – | (21) | – | 39 (30.0, 16.2%) | |
| Sedation/Sleepiness | (30) | – | (81) | – | (12) | – | (4) | (21) | – | 29 (19.0, 12.0%) | |
| Fatigue | – | (75) | – | – | – | – | – | – | (23) | 23 (35.9, 9.5%) | |
| Sleep problems | – | – | (19) | (58) | – | (25) | – | – | (10) | 18(20.5, 7.5%) | |
| Mood swings | (30) | – | (31) | – | – | (25) | – | – | – | 14 (23.0, 5.8%) | |
| GI discomfort | – | – | (19) | – | (7) | (8) | – | (21) | (8) | 14 (10.1, 5.8%) | |
| Vomiting | – | – | (19) | – | – | – | (5) | – | (15) | 13 (10.9, 5.4%) | |
Note. First percentage in right column is based on total sample for cells where adverse event is reported; second percentage is based on all 241 subjects across all studies and assumes that investigators screened for that adverse event in all studies. Whereas neither percentage may be correct, we regard the first as more accurate, albeit possibly high.